Journal articles: 'European Pharmacopoeia'

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Moiseev, S. V., N. E. Kuz’mina, and A. I. Luttseva. "NMR as Used in the Russian and Foreign Pharmacopoeias for Quality Control of Medicinal Products." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 12, no. 1 (February 18, 2022): 8–23. http://dx.doi.org/10.30895/1991-2919-2022-12-1-8-23.

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The ongoing development of the Pharmacopoeia of the Eurasian Economic Union and the current trend for harmonisation of the Russian Pharmacopoeia with the world leading pharmacopoeias suggest the necessity of studying how different pharmacopoeias use nuclear magnetic resonance (NMR) for quality control of medicinal products. The aim of the study was to compare the extent of medicine quality characteristics assessed by NMR in the Russian and foreign pharmacopoeias. The review summarises the experience of various national and world pharmacopoeias in using the NMR method for quality control of medicines and certification of pharmacopoeial reference materials. The comparative analysis covered the following quality parameters: active ingredient identification, determination of the composition of non-stoichiometric compounds, determination of the average polymer chain length in polymers and block copolymers, determination of the absolute content of the active ingredient, identification and quantification of impurities, polymorphism, and crystallinity. It was shown that the United States and Japanese Pharmacopoeias are leading the way in introducing the NMR method into pharmacopoeial analysis. There have been some positive trends in the introduction of the NMR method in the State Pharmacopoeia of the Russian Federation as well. It was concluded that changes are needed in the general chapters “Nuclear Magnetic Resonance Spectroscopy” and “Reference Standards” of the State Pharmacopoeia of the Russian Federation, 14th ed. in order to harmonise the texts with those of the Eurasian Pharmacopoeia and the European Pharmacopoeia and to allow for the possibility of direct identification of a substance by complex analysis of NMR spectral data, without comparing the test sample and the reference standard spectra. The NMR method should be included in the list of absolute methods used for determination of purity of primary chemical reference substances during certification.

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Grizodoub, Oleksandr. "Twenty Years of The State Pharmacopoeia of Ukraine: The Experience of Establishing the First National Pharmacopoeia in The Post-Soviet Area." SSP Modern Pharmacy and Medicine 1, no. 2 (October 14, 2021): 1–20. http://dx.doi.org/10.53933/sspmpm.v1i2.22.

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The quality and life expectancy of the population depends on the level of access to modern, high-quality, effective and evidence-based medical and pharmaceutical care. These types of care play a significant role in the pharmacotherapy of cardiovascular disease (CVD), which is one of the main medical, biological and socio-economic problems of society. CVDs cause 67% of all deaths in Ukraine. For comparison: in France and Japan, this component in the structure of mortality is 29%, in the United States - 31%. Heart attacks are one of the main nosologies that cause high mortality from COVID. The 1st October, 2021 marks 20 years since the introduction of the State Pharmacopoeia of Ukraine. The purpose of the study was to experience of creating the first national pharmacopoeia in the post-Soviet space. Ukraine, the first in the post-Soviet space, managed to create its own State Pharmacopoeia, which is fully harmonized with the European Pharmacopoeia and takes into account national specifics. The State Pharmacopoeia of Ukraine relies on its own National system of pharmacopoeial standard samples and pharmacopoeial program of professional testing of control laboratories as feedback from users. The State Pharmacopoeia of Ukraine is not funded by the state, and the Pharmacopoeia Center is a completely self-supporting structure. In general, the State Pharmacopoeia of Ukraine can be considered the best National Pharmacopoeia in the post-Soviet space.

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Vodyakova, M. A., A. R. Sayfutdinova, E. V. Melnikova, and Yu V. Olefir. "Comparison of the World Pharmacopoeias’ Requirements for the Quality of Cell Lines." BIOpreparations. Prevention, Diagnosis, Treatment 20, no. 3 (September 18, 2020): 159–73. http://dx.doi.org/10.30895/2221-996x-2020-20-3-159-173.

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The cell line is one of the necessary components of a biomedical cell product (BMCP) which can include only viable human cells. In addition, human, animal, insect, or bacterial cell lines can be used as a substrate for the production of some biological drugs. The list of quality parameters and test methods for medicinal products quality control are specified in the State Pharmacopoeia of the Russian Federation, but it contains only a few general monographs on blood products and a few requirements for cell lines as substrates for the production of biological drugs (which cover all types of cells). Currently, there is no regulatory document comparable to the State Pharmacopoeia of the Russian Federation that would contain requirements and test methods for BMCP quality control in the Russian Federation. Thus, one of the issues that arises both during quality control and approval of BMCPs is the lack of a regulatory document defining requirements for BMCP quality parameters and test methods. However, some general monographs of the Russian Pharmacopoeia and other pharmacopoeias can be used for quality control of both cell lines and non-cellular components. The aim of the study was to analyse and compare different pharmacopoeial requirements for the quality of cell lines used as components in human cell- and tissue-based products (comparable to BMCPs), which could be used in BMCP quality control. The paper analyses general monographs of the United States Pharmacopoeia (USP), European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia, Pharmacopoeia of the Republic of Belarus, including general monographs on biological/biotechnological products, because their requirements apply to human cell lines included as components in products similar to BMCPs. The analysed approaches and methods of quality control of cell- and tissue-based products described in the USP and Ph. Eur. could form the basis for elaboration of general monographs for the Russian Pharmacopoeia, including identification, potency, viral safety, and mycoplasma tests that are based on the nucleic acid amplification technology and other tests for cell lines as components of BMCPs.

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Bouin, Anne-Sophie, and Michael Wierer. "Quality standards of the European Pharmacopoeia." Journal of Ethnopharmacology 158 (December 2014): 454–57. http://dx.doi.org/10.1016/j.jep.2014.07.020.

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Shchukin, V. M., A. A. Erina, E. A. Lisman, and O. A. Vaganova. "Problems of Establishing Limits for Arsenic Content in Brown Algae and Brown Algae-Containing Medicinal Products." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 9, no. 3 (September 10, 2019): 167–72. http://dx.doi.org/10.30895/1991-2919-2019-9-3-167-172.

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Algae tend to accumulate elemental toxic substances in high concentrations. Algae are widely used in the food and pharmaceutical industries, and this dictates the need to establish limits for the content of toxic substances that they may contain. The aim of the study was to analyse the requirements of the Russian and foreign pharmacopoeias and other regulatory documents concerning the limits for the content of arsenic in brown algae. The paper presents the results of analysis of monographs from the State Pharmacopoeia of the Russian Federation, XIII and XIV editions, draft version of the Pharmacopoeia of the Eurasian Economic Union, United States Pharmacopoeia, Japanese Pharmacopoeia, European Pharmacopoeia, and Ayurvedic Pharmacopoeia of India containing limits for the content of arsenic in herbal medicinal products (HMPs). In addition, the authors analysed Russian, international and foreign food industry and dietary supplements regulations, as well as scientific publications on arsenic content in brown algae. They also considered the nomenclature of arsenic compounds to be determined and controlled in medicinal products, highlighted the main approaches to and identified global trends in establishing the limits for their content in HMPs. The paper summarises specific aspects of inorganic arsenic compounds accumulation by brown algae. It was demonstrated that the majority of foreign pharmacopoeias either have specific norms for arsenic content in brown algae, which differ from the norms for HMPs, or have general norms that take into account different toxicity levels of organic and inorganic arsenic compounds. There is a tendency to control the content of elemental toxic substances based on their maximum allowable daily intake. The paper substantiates the need for separate determination of toxic inorganic arsenic compounds and potentially toxic methyl arsonate and dimethyl arsinate in HMPs.

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Gray, Elaine, Trevor Barrowcliffe, and Barbara Mulloy. "Characterization of Unfractionated Heparin: Comparison of Materials from the last 50 Years." Thrombosis and Haemostasis 84, no. 12 (2000): 1052–56. http://dx.doi.org/10.1055/s-0037-1614170.

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SummaryPhysicochemical and anticoagulant characteristics of 27 samples from recent batches of commercially produced unfractionated heparin have been determined as part of the process of establishment of the 5th International Standard Unfractionated Heparin. They have been compared with current heparin standards (European Pharmacopoeia, United States Pharmacopoeia, Chinese), with the 4th International Standard Unfractionated Heparin, and with the three predecessor International Standards. The results indicate that the 4th International Standard Unfractionated Heparin, established in 1982, has significantly lower molecular weight and specific activity than recently produced heparin; this is also true of all preceding International Standard Heparins and of the United States Pharmacopoeial standard. The composition of commercial unfractionated heparin may therefore have changed over time; reasons for this are discussed.

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Rzepa, Józef, Mieczysław Sajewicz, Tomasz Baj, Patrycja Gorczyca, Magdalena Włodarek, Kazimierz Głowniak, Monika Waksmundzka-Hajnos, and Teresa Kowalska. "A Comparison of Methodical Approaches to Fingerprinting of the Volatile Fraction from Winter Savory (Satureja montana)." Chromatography Research International 2012 (January 12, 2012): 1–8. http://dx.doi.org/10.1155/2012/596807.

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It was the aim of this study to compare the efficiency of the different essential oil extraction methods upon the two winter savory (Satureja montana) samples of different origin. The compared techniques were the headspace gas chromatography with mass spectrometric detection (HS-GC/MS) run at the two different headspace temperatures (i.e., at 80 and 100°C) and the three different steam distillation techniques preceding the GC/MS analysis. HS-GC/MS is considered as the technique of the first choice, and the compared steam distillation techniques are recommended, respectively, by Polish Pharmacopoeia, European Pharmacopoeia, and the Polish Patent. Adequate conclusions were drawn as to the advantage of HS-GC/MS (not having the pharmacopoeial recommendation) over the different steam distillation techniques and the drawbacks of each individual analytical procedure were discussed.

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Melnyk, Halyna, Tatyana Yarnykh, and Marina Buryak. "Pharmacopeial aspects of preparation of infusions and decoctions in pharmacies." EUREKA: Health Sciences, no. 4 (July 30, 2021): 87–93. http://dx.doi.org/10.21303/2504-5679.2021.001971.

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An analytical review of pharmacopoeial aspects of preparation of infusions and decoctions in pharmacies is presented. The aim of this work is to conduct a comparative analysis of pharmacopoeial requirements for the technology of infusions and decoctions in pharmacies. Materials and methods of the research. Comparative analysis of pharmacopoeial requirements was performed using methods of systematic and structural-logical analysis. Results and discussions. It was found that in many pharmacopoeias (European, British, Italian, French, Czech, Kazakh) there are no instructions on the pharmacy technology of these dosage forms. Only the pharmacopoeias of Japan, Austria, Belarus and Russia contain separate monographs on the extemporaneous preparation of infusions and decoctions. After analyzing these monographs, it was found that the definition of infusions and decoctions as a dosage form differs. It was found that the Japanese Pharmacopoeia regulates the preliminary preparation of medicinal plant raw materials (soaking for 5 minutes in water), in other pharmacopoeias there is no such requirement. When conducting a comparative analysis of the technology of preparation of infusions and decoctions, we observe that the ratio of medicinal plant raw materials (MPRM) and extractant and extraction modes differ. Conclusions. An analytical review of pharmacopoeial aspects of preparation of infusions and decoctions in pharmacies is presented. A comparative analysis of the requirements for technology and quality control of infusions and decoctions in accordance with pharmacopoeial articles revealed both different and similar information. The results of the research showed that despite the differences in the structures of articles and names, as well as approaches to the definition of this dosage form, some requirements are similar (particle size of MPRM). The differences that were found include the ratio of MPRM and extractant, extraction modes. Taking into account the data of the analysis and the existing national requirements, the authors proposed a draft general pharmacopoeial article “Infusions and decoctions made in pharmacies”.

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Khokhlova, K. O., O. A. Zdoryk, N. V. Sydora, and V. I. Shatrovska. "Chromatographic Profiles Analysis of Fruits of Crataegus L. Genus by High-Performance Thin-Layer Chromatography." European Pharmaceutical Journal 66, no. 2 (November 1, 2019): 45–51. http://dx.doi.org/10.2478/afpuc-2019-0020.

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Abstract It was known that hawthorn - Crataegus L. is a polymorphic genus. Two hawthorn species and their hybrids are included in the European Pharmacopoeia, twelve – in Ukrainian pharmacopoeia. Determination of chromatographic profiles of hawthorn fruits species native to Ukraine and other countries that are non-pharmacopoeial, but have sufficient plant raw material base, is essential for quality control of drugs. Aim. To analyze and compare the chromatographic profiles of fruits of 23 Crataegus L. species on phenolic compounds, evaluated by means of high-performance thin-layer chromatography procedure (HPTLC), and determine the specific features of chromatographic fingerprints. Materials and Methods. A total of 39 samples of fruits of 23 hawthorn species that are native to Europe, Asia and North America, such as Crataegus monogyna, C. laevigata/C. oxyacantha, C. leiomonogyna, C. curvisepala, C. pseudokyrtostyla, C. fallacina, C. subrotunda, C. ambigua, C. pentagyna, C. sanguinea, C. chlorosarca, C. almaatensis, C.pseudoheterophylla subsp. turkestanica, C. pinnatifida, C. pentagyna subsp. pseudomelanocarpa, C. punctata, C. pringlei, C. festiva, C. douglasii, C. holmesiana, C. submollis, C. flabellata, C. canadensis were investigated. The analysis has been done following the TLC method from European Pharmacopeia modified into HPTLC, using automated HPTLC herbal system (CAMAG, Switzerland). The results have shown that chromatographic profiles of phenolic constituents of nine Crataegus L. species of Europe, both pharmacopoeial and non-pharmacopoeial, were quite similar, despite the significant morphological distinctions. The chromatographical profiles of three species of Asia were similar to the pharmacopoeial species; three other species looked different and had specific marker zones. In addition, eight Crataegus L. species of North America had specific markers helping for discriminative analysis from pharmacopoeial species. Conclusion. The findings could help to identify the possible adulterations and prevent the falsification of finished products. The results will be taken into consideration during revision of the Ukrainian national pharmacopoeial monograph for hawthorn fruits.

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Dymarczyk, Iwona. "Medicines from the first pharmacopoeia listed on the apothecary majolica vessels from the Mateusz B. Grabowski collection at the Museum of Pharmacy in Kraków." Opuscula Musealia 27 (2021): 169–83. http://dx.doi.org/10.4467/20843852.om.20.009.13748.

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This article concerns medicinal preparations from the first European pharmacopoeia listed on the cartouches of apothecary majolica vessels (16th‒18th century) from the Grabowski collection at the Museum of Pharmacy in Kraków. The materials for comparison are three 16th-century works: Ricettario Fiorentino (1550), Pharmacopoea by J. Placotomus (1560) and Dispensatorium by V. Cordus (1563). The inscriptions on the apothecary jars for which they were meant comprise greatly important information carriers about medicine in the old days. Their deciphering can also be helpful when dating these objects.

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Charton, E., M. Wierer, J. M. Spieser, A. van Dorsselaer, and G. Rautmann. "A Somatropin Counterfeit Challenging the European Pharmacopoeia Monograph." Pharmacy and Pharmacology Communications 5, no. 1 (January 1, 1999): 61–66. http://dx.doi.org/10.1211/146080899128734082.

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Antonova, N. P., I. M. Morgunov, S. P. Prokhvatilova, E. P. Shefer, A. M. Kalinin, and T. A. Golomazova. "Determination of Anthracene Derivatives in the Antihaemorrhoidal Medicinal Herb Mixture Proctophytol® Using the European Pharmacopoeia Method." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 10, no. 2 (June 20, 2020): 129–36. http://dx.doi.org/10.30895/1991-2919-2020-10-2-129-136.

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Specialists in pharmacognosy are facing an important task of improving quality control methods for combination herbal medicinal products in order to enable reliable assessment of the content of active substances that are responsible for the drug’s pharmacological effect.The aim of the study was to investigate the possibility of using the European Pharmacopoeia method to determine the total content of anthracene derivatives in the antihaemorrhoidal medicinal herb mixture Proctophytol® and to propose limit values for the total content of anthracene derivatives.Materials and methods: individual mixture components containing anthracene derivatives, such as senna leaves and frangula bark, as well as model mixtures containing these individual components in a 1:1 ratio, and a model mixture imitating Proctophytol® were used in the study. The determination of the anthracene derivatives content was carried out using spectrophotometry.Results: it was demonstrated that the European Pharmacopoeia method could be used to assess the quality of Proctophytol® in terms of anthracene derivatives total content. The spectrophotometric method described in the European Pharmacopoeia has advantages over the methods described in manufacturer specifications for Russian products, because it allows for thorough extraction of the active substances and is standardized for anthracene derivatives.Conclusions: the European Pharmacopoeia method was adjusted to determine anthracene derivatives in the medicinal herb mixture Proctophytol®. It was proposed to use 70% ethanol instead of 70% methanol as extraction solvent. The authors identified optimum sample weights and test solution dilutions, and calculated and verified the limit for anthracene derivatives content—“Not less than 1.9%”. The adjusted method can be recommended for inclusion in the monographs of the State Pharmacopoeia of the Russian Federation for medicinal herb mixtures similar to Proctophytol®.

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Le Tarnec, Caroline Larsen. "The European Pharmacopoeia: A Common European Initiative by the Council of Europe." CHIMIA International Journal for Chemistry 58, no. 11 (November 1, 2004): 798–99. http://dx.doi.org/10.2533/000942904777677254.

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Castle, P. "Combined Vaccines: Policy and Practice in the European Pharmacopoeia." Biologicals 22, no. 4 (December 1994): 381–87. http://dx.doi.org/10.1006/biol.1994.1058.

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Czigle, Szilvia, Jaroslav Tóth, Nikoletta Jedlinszki, Erzsébet Háznagy-Radnai, Dezső Csupor, and Daniela Tekeľová. "Ginkgo biloba Food Supplements on the European Market – Adulteration Patterns Revealed by Quality Control of Selected Samples." Planta Medica 84, no. 06/07 (March 5, 2018): 475–82. http://dx.doi.org/10.1055/a-0581-5203.

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AbstractThe aim of this study was to prove whether Ginkgo biloba food supplements on the European market comply with pharmaceutical quality, and whether their composition satisfies the European Pharmacopoeia criteria. Medicinal products containing a standardised Ginkgo leaf extract are used for the improvement of cognitive impairment and quality of life in mild dementia. Further, Ginkgonis folium is used for the treatment of peripheral circulation disorders. Pharmacopoeial Ginkgo dry extract contains 22.0 – 27.0% flavonoids and 5.4 – 6.6% terpene lactones (ginkgolides, bilobalide). In addition to its widespread use as an herbal medicine (herbal medicinal product), the same extract can be an ingredient in food supplements. The content of active secondary metabolites was quantified in a number of European food supplements containing Ginkgo dry extract or Ginkgo leaf. Flavonoids were quantified using a modified pharmacopoeial HPLC-UV method, and terpene lactones (ginkgolides A, B, C, and bilobalide) using LC-MS/MS. Some Ginkgo leaf supplement samples were also analysed by microscopy. The quality of food supplements on the European market is dubious. In this paper, we present selected examples of several methods of adulteration and falsification, including higher/lower doses of Ginkgo dry extract or Ginkgo leaf than declared and the addition of undeclared extraneous materials. These examples reveal several patterns in the manufacturing of adulterated products.

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Yuldasheva, Sokhiba, Sanjar Sherimbetov, Abdukodir Tulaganov, and Khalima Khaydarova. "Detection of heavy metals and pesticides in the raw materials of Araxacum Officinale Wigg and Taraxacum Kok-saghyz Rodin plants." E3S Web of Conferences 244 (2021): 02035. http://dx.doi.org/10.1051/e3sconf/202124402035.

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Taraxacum officinale Wigg and the results of scientific research on the development of modern methods of physicochemical analysis of heavy metals that can be found in raw materials of Taraxacum kok-saghyz Rodin, and the presence of pesticides in plants using the GOST (governmental standard) European Pharmacopoeia standard. Methods for the quantitative determination of inductively coupled plasma mass spectrometry (ICP-MS) of heavy metals; macro and microelements in plant raw materials have been developed. The test for the presence of pesticides and heavy metals in plants according to the GOST standard of the European Pharmacopoeia was carried out in accordance with the Sanitary Rules and Standards of the Republic of Uzbekistan.

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&NA;. "The European Pharmacopoeia monographs for heparin preparations have been revised,." Reactions Weekly &NA;, no. 1212 (July 2008): 3. http://dx.doi.org/10.2165/00128415-200812120-00009.

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OLSSON, BO. "The Revision of the Inhalanda Monograph of the European Pharmacopoeia." Journal of Aerosol Medicine 11, s1 (June 1998): S—13—S—16. http://dx.doi.org/10.1089/jam.1998.11.suppl_1.s-13.

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Volford, Orsolya, Jo´zsef Va´mos, and Miha´ly Taka´cs. "The significance of different chromatographic methods in the European Pharmacopoeia." International Journal of Pharmaceutics 137, no. 1 (June 21, 1996): 111–15. http://dx.doi.org/10.1016/0378-5173(96)04513-9.

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Roncea, Florentina, Radu Cazacincu, Horatiu Miresan, Adrian Cosmin Rosca, Mihaela Bratu, and Antoanela Popescu. "Sambucus nigra (L.) liophylised extract as source of direct compression tablets obtaining." Analele Universitatii "Ovidius" Constanta - Seria Chimie 24, no. 2 (December 1, 2013): 79–82. http://dx.doi.org/10.2478/auoc-2013-0015.

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AbstractThe aim of this paper is the valorization of a 10 % anthocyanins elderberries lyophilized extract standardized as cyanidin-3-glucoside in lozenges obtained by direct compression and quality lozenges evaluation according to Romanian and European pharmacopoeia tests. The resulting lozenges with a 600 mg concentration of a 10 % anthocyanins elderberries lyophilized extract standardized as cyanidin-3-glucoside were evaluated using the following tests: appearance and mass uniformity (20 lozenges) disintegration time (6 lozenges), hardness (10 lozenges), anthocyanins assay expressed as cyanidin-3-glucoside using a spectrometric method at pH differential values. The results are expressed as means± standard deviation. The tablets for the two formulas have the same appearance (flat, round, colored in purple - red, non gritty), the dimensional characteristics (height, thickness) are different, average mass complies the pharmacopoeia standards. The lozenges from formula 2 have a higher resistance (215.7 N) and a lower disintegration time (11 min.) according to the official recommended values, due to differences from carbopol polymers differences in properties at the same concentration used in the two formulas. Using the direct compressible products described in this study, the direct compression technique can be easily applied for the manufacture of lozenges, thus ensuring their stability by avoiding heat and humidity factors during the manufacturing process. The resulting lozenges from formula 1 respect the quality specifications provided by the Romanian Pharmacopoeia Xth edition, the European Pharmacopoeia. The lozenges presented a high mechanical resistance (110 N) and a good disintegration time (15 min.)

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Schüssele, Andrea, and Annette Bauer-Brandl. "Note on the measurement of flowability according to the European Pharmacopoeia." International Journal of Pharmaceutics 257, no. 1-2 (May 2003): 301–4. http://dx.doi.org/10.1016/s0378-5173(03)00142-x.

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Miraldi, Elisabetta, Daniela Giachetti, and Sara Ferri. "Quality control of aromatic drugs reported in European Pharmacopoeia 3rd edition." Il Farmaco 56, no. 5-7 (July 2001): 365–71. http://dx.doi.org/10.1016/s0014-827x(01)01088-6.

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Shchukin, V. M., N. E. Kuz’mina, Yu N. Shvetsova, and A. I. Luttseva. "Development and Validation of Procedures for Determination of Elemental Toxicants in Herbal Substances and Herbal Medicinal Products." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 12, no. 1 (February 11, 2022): 65–78. http://dx.doi.org/10.30895/1991-2919-2022-12-1-65-78.

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When the approach to quality control of herbal substances (HSs) and herbal medicinal products (HMPs) changed from determination of the total content of heavy metals by calorimetry to selective determination by spectrometric techniques, many manufacturers of such products failed to meet the new requirements in their registration dossiers. Test procedures submitted by manufacturers often need to be clarified, and validation protocols often lack data.The aim of the study was to provide recommendations to HS and HMP manufacturers on the choice of test methods, materials, reagents, methods of organic matrix mineralisation, and main validation parameters, as well as recommendations on validation of the procedure for elemental toxicants determination, and preparation of the “Heavy metals and arsenic” part of the regulatory submission.Materials and methods: the study included analysis and systematisation of scientific literature, requirements of the Russian and foreign pharmacopoeias, guidelines, manuals on instrumental methods of analysis, and first-hand experience in elemental analysis of various types of HSs and HMPs.Results: the authors formulated recommendations on the choice of sample mineralisation conditions for quantification of elemental impurities in biological products, and substantiated requirements for the reagents, materials, and equipment. The paper compares different methods of elemental analysis. It was demonstrated that the main mistakes made by manufacturers stem from disregard to the organic matrix effect on the measurement results and lack of agreement between the impurity concentration being determined and the range of the calibration curve used. The paper gives acceptance criteria for validation parameters of test procedures for heavy metals and arsenic determination in HSs and HMPs.Conclusions: it is not correct to use reference standards containing heavy metals as inorganic salts not bound to organic compounds, for HS and HMP analysis. The criteria given in the European Pharmacopoeia and the United State Pharmacopoeia can be used for a number of validation parameters, when they are not included in the Russian Pharmacopoeia.

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Ponoran, Carmen. "Manufacture of gemmotherapy extract from Pol Henry to today." Farmacist.ro 1, no. 1 (March 16, 2020): 39–42. http://dx.doi.org/10.26416/farm.192.1.2020.2903.

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The pharmaceutical form and preparation method, initially proposed by Dr. Pol Henry, was adopted and improved. The improved method was officialized in 1965 in the French Pharmacopoeia, under the denomination of glycerol macerates. This denomination means an extract obtained with glycerol and ethanol, by cold extraction – maceration. The improvement of the Dr. Pol Henry’s initial method regards the cut of the vegetal raw material before the extraction. In initial method the buds were not cut, the extraction being conducted on entire buds. The pharmaceutical technology practice demonstrated and it is part of official pharmacopoeia method, that the extraction is more efficient on the cut vegetal raw material. Neither today exist a unitary method used by all producers for obtaining glycerol macerates, some of them uses also purified water at extraction. The method from French Pharmacopoeia was later adopted also by the the European Pharmacopoeia. Today are used also the concentrated glycerol macerates, due to the fact that the ethanol content of one administration is much more less than in diluted glycerol macerates and appears also complex formula, containing more unitary glycerol macerates, in that the individual components act synergically and enhancer one to the other.

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Wojtunik-Kulesza, Karolina, Kamila Kasprzak-Drozd, Daniel Sajdlowski, Anna Oniszczuk, Wojciech Swiatkowski, and Monika Waksmundzka-Hajnos. "Scutellaria baicalensis – a small plant with large pro-health biological activities." Current Issues in Pharmacy and Medical Sciences 34, no. 1 (March 1, 2021): 55–59. http://dx.doi.org/10.2478/cipms-2021-0010.

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Abstract Scutellaria baicalensis, known also as Huang-Qin is a traditional Chinese plant used in medicine for at least 2000 years. The plant is widely distributed in Japan, Korea, Mongolia and Russia, and is listed in Chinese Pharmacopoeia, European Pharmacopoeia and British Pharmacopoeia. The interest in Huang-Qin results from various biological activities which are primarily related to secondary plants metabolites consisting of flavonoids, phenolic compounds and terpenes. It is known that the compounds are active against numerous diseases and protect the organism against harmful pathogenic agents. Particular attention is paid to baicalein, wogonin and oroxylin A – which are characteristic secondary metabolites of the plant. In this paper, we focused on phytochemical analysis and selected biological activities used in periodontal and cardiovascular problems. The presented studies confirm the ability of Huang-Qin to scavenge free radicals, moreover, that it presents anti-bacterial, anti-inflammatory and enzyme inhibitory activities.

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Abramova, E. G., Yu K. Gavrilova, S. V. Generalov, O. A. Lobovikova, I. V. Shulgina, A. V. Komissarov, and A. K. Nikiforov. "Development of an in-house reference standard for anti-rabies immunoglobulin potency, to be used in the virus neutralisation test in a Vero cell culture." BIOpreparations Prevention Diagnosis Treatment 22, no. 1 (March 10, 2022): 38–48. http://dx.doi.org/10.30895/2221-996x-2022-22-1-38-48.

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The development and use of new methods of quality control of medicines involve the use of a lot of reference materials in quality control testing. Specialists of the Russian Research Antiplague Institute “Microbe” have proposed an alternative methodological approach to determination of potency of anti-rabies immunoglobulin in cell culture, which requires the development of an in-house reference standard (RS) certified against the biological reference preparation (BRP) of the European Pharmacopoeia¾human rabies immunoglobulin.The aim of the study was to develop and evaluate the metrological characteristics of an in-house RS for anti-rabies immunoglobulin potency, to be used in the virus neutralisation test in a Vero cell culture.Materials and methods: The following materials were used in the study: equine rabies immunoglobulin, Vero continuous cell culture, fixed rabies virus (Moscow 3253Vero strain), human rabies immunoglobulin BRP of the European Pharmacopoeia. The potencies of the candidate in-house RS and rabies immunoglobulin samples were determined in the neutralisation test in cell culture. The results were recorded using a fluorescent microscope. Statistical processing was carried out in accordance with general chapter 1.1.0014.15 of the State Pharmacopoeia of the Russian Federation, 14th edition.Results: the certified value of the in-house RS potency was 180.8±18.8 IU/mL. The confidence limits were determined at the 0.95 probability level. The shelf life of the in-house RS is 1.5 years (when stored according to the sanitary regulation SanPiN 3.3686-21). The certified in-house RS was assigned with the number 41-01-20. A set of technical and operational documentation was developed and approved for the in-house RS. The developed in-house RS can be used for in vitro determination of anti-rabies immunoglobulin potency, expressed in international units, to confirm its compliance with the product specification file.Conclusions: the authors developed an in-house RS for anti-rabies immunoglobulin potency, to be used in the virus neutralisation test in cell culture, certified against the human rabies immunoglobulin BRP of the European Pharmacopoeia.

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Ganzetti, Roberta, Serena Logrippo, Matteo Sestili, Alessandro Caraffa, Marco Cespi, Giuseppe Pelliccioni, Paolo Blasi, and Giulia Bonacucina. "Tablet Splitting in Elderly Patients with Dementia: The Case of Quetiapine." Pharmaceutics 13, no. 9 (September 20, 2021): 1523. http://dx.doi.org/10.3390/pharmaceutics13091523.

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Quetiapine is an atypical antipsychotic approved for treating schizophrenia, bipolar depression, and mania but is frequently used in an off-label manner to control the behavioral and psychological symptoms of dementia in elderly patients with dementia. Due to the need to personalize doses for elderly patients with dementia, quetiapine tablet manipulation is widespread in hospital settings, long-term care facilities, and patient homes. The aim of this study was to assess the impact of the different splitting techniques on quetiapine fumarate tablets by analysing the obtained sub-divided tablets and to discuss compliance with the European Pharmacopoeia limits on whole and split tablets. Quetiapine fumarate tablets of two dose strengths were taken at random (in a number able to assure a power of 0.8 during statistical comparison) and were split with a kitchen knife or tablet cutter. The weight and the drug content were determined for each half tablet. The obtained data were compared to the European Pharmacopoeia limits. The differences between the different splitting techniques were statistically tested. Data showed that split tablets, independently of the dose strength and the technique employed, were not compliant with the European Pharmacopoeia specifications for both entire and subdivided tablets in terms of weight and content uniformity. Thus, such a common practice could have potential effects on treatment efficacy and toxicity, especially when also considering the fragility of the elderly target population in which polypharmacotherapy is very common. These results indicate a compelling need for flexible quetiapine formulations that can assure more accurate dose personalization.

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SIPPONEN, ARNO, and KIRSI LAITINEN. "Antimicrobial properties of natural coniferous rosin in the European Pharmacopoeia challenge test." APMIS 119, no. 10 (July 18, 2011): 720–24. http://dx.doi.org/10.1111/j.1600-0463.2011.02791.x.

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Doesburg, P., J. O. Andersen, C. Scherr, and S. Baumgartner. "Empirical investigation of preparations produced according to the European Pharmacopoeia monograph 1038." European Journal of Pharmaceutical Sciences 137 (September 2019): 104987. http://dx.doi.org/10.1016/j.ejps.2019.104987.

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Borovikova, Natal'ya Anatol'yevna. "EXTRACTION SPECIMENS BASED ON THE BUCKTHORN BARK AND METHODOLOGICAL APPROACHES TO IDENTIFY ANTHRACENE DERIVATIVES INCLUDED." chemistry of plant raw material, no. 2 (November 20, 2018): 73–81. http://dx.doi.org/10.14258/jcprm.2019023722.

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The article provides an overview of drugs based on buckthorn bark included in the State register of medicines of the Russian Federation and patented in recent years. The methods of quantitative determination of anthracenes-derived raw materials of buckthorn according to the state Pharmacopoeia of the Russian Federation XI and XIII editions and the European Pharmacopoeia are analyzed and presented in the comparative aspect. The main representatives of the anthracene-derived buckthorn are shown for a number of sources, taking into account modern phytochemical studies. The algorithm of development of a technique of spectrophotometric quantitative determination of anthracenes derivatives in buckthorn bark and extraction preparations from it is gradually presented. Studied and selected the optimal conditions of extraction: raw material grinding – 1 mm, extractant – 10% sodium hydroxide solution, the ratio of raw materials and extractant – 0.1 : 100, the extraction temperature in a water bath 100 °C, the duration of extraction – 30 minutes. The analytical maximum of 510 nm was established, a certified sample of frangul-emodin was used as a standard substance, and an experimental calculation of the specific absorption rate of frangul-emodin interaction products with an alkaline-ammonia mixture was presented. In the research we describe an optimized pharmacopoeial methodology, metrological characterizations and results of quantitative determination of the anthracene derivatives in aqueous and alcohol extracts based on the buckthorn bark. The content of the amount of anthracenes in the samples of raw materials of five domestic producers. The content varies from 4.35 to 4.85%.

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Kriukova, Anna, Dmytro Lytkin, Mykhailo Marchenko, and Inna Vladymyrova. "Development of green production technology and research of harpagophytum procumbens root dry extract." ScienceRise: Pharmaceutical Science, no. 4(32) (August 31, 2021): 43–49. http://dx.doi.org/10.15587/2519-4852.2021.239332.

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The aim of this work is to study of standardization parameters and pharmacological properties of Harpagophytum procumbens (H. procumbens) root dry extract. Materials and methods – obtaining of H. procumbens root dry extract was performed in accordance with developed scheme that is characterized by simplicity and cost-effectiveness of technology compared to analogous scheme. Study of standardization parameters of obtained extract was performed in accordance with the requirements of the monograph «Harpagophyti extractum siccum» of the State Pharmacopoeia of Ukraine 2.2., harmonized with the monograph «Harpagophyti extractum siccum» of the European Pharmacopoeia 9.5. Pharmacology study of analgesic and anti-inflammatory activities were conducted on the rat paw formalin-induced edema model. Results. Obtained H. procumbens root dry extract is a free flowing, non-hygroscopic, light brown powder with taste and odor that is specific to raw material of H. procumbens. Determined loss on drying was 3.2±0.18 %. Content of heavy metals in dry extract was not more than 0.01 % (100 ppm). Harpagoside was identified by TLC method. Chromatographic zones on the obtained chromatograms of the reference solution and test solutions are the same in intensity of a color, cross-over and sharpness of development. Based on the results of the research performed by HPLC method, it has been established that content of harpagoside in investigated H. procumbens root dry extract is 2.50±0.02 %. According to the results of pharmacological research it was found that investigated dry extract (the content of harpagoside is not less than 37.0 mg/kg) showed a higher activity compared to reference drug («Phong Te Thap»). Conclusions. A new method of obtaining dry extract of H. procumbens (3.5:1) was proposed. The developed green production technology is simple; it does not require special equipment and expensive solvents. A correspondence of quality parameters with the requirements of State Pharmacopoeia of Ukraine and European Pharmacopoeia: appearance, identification of harpagoside and fructose, loss of drying, content of heavy metals, assay of harpagoside (2.50±0.02 %) was set. Analgesic and anti-inflammatory activities of H. procumbens dry extract has been established

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Charton, Emmanuelle. "The role of European Pharmacopoeia monographs in setting quality standards for biotherapeutic products." Generics and Biosimilars Initiative Journal 5, no. 4 (December 15, 2016): 174–79. http://dx.doi.org/10.5639/gabij.2016.0504.045.

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Li, B., A. Van Schepdael, J. Hoogmartens, and E. Adams. "Mass spectrometric characterization of gentamicin components separated by the new European Pharmacopoeia method." Journal of Pharmaceutical and Biomedical Analysis 55, no. 1 (April 2011): 78–84. http://dx.doi.org/10.1016/j.jpba.2011.01.017.

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Enesei, Dániel, Imre Kapui, Szabolcs Fekete, and Róbert Kormány. "Updating the European Pharmacopoeia impurity profiling method for terazosin and suggesting alternative columns." Journal of Pharmaceutical and Biomedical Analysis 187 (August 2020): 113371. http://dx.doi.org/10.1016/j.jpba.2020.113371.

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Piwowarski, Jakub P., and Anna K. Kiss. "C -glucosidic Ellagitannins from Lythri herba (European Pharmacopoeia ): Chromatographic Profile and Structure Determination." Phytochemical Analysis 24, no. 4 (December 28, 2012): 336–48. http://dx.doi.org/10.1002/pca.2415.

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Ghinami, C., V. Giuliani, A. Menarini, F. Abballe, S. Travaini, and T. Ladisa. "Electrochemical detection of tobramycin or gentamicin according to the European Pharmacopoeia analytical method." Journal of Chromatography A 1139, no. 1 (January 2007): 53–56. http://dx.doi.org/10.1016/j.chroma.2006.10.099.

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Leonel, Miriam de Fátima Vianna, Cristina Duarte Vianna Soares, and Arminda Lucia Siqueira. "Comparison of pharmacopeial statistical methods applied in microbiological assay for antibiotics potency determination using parallel lines and three-dose level." Brazilian Journal of Pharmaceutical Sciences 48, no. 3 (September 2012): 565–76. http://dx.doi.org/10.1590/s1984-82502012000300024.

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Pharmaceutical equivalence studies, useful for checking the interchangeability of generic medicines and their respective innovator medicines, have been carried out in Brazil since 1999, as a consequence of the establishment of the generic medicine policy. For medicines containing antibiotics, microbiological assays are often the most appropriate method. However, the statistical methods applied in these assays are not widely known due to the difficult access to official codes and/or little knowledge of the statistical tools of analysis. Thus, the aim of this work was to compare the statistical methods for determining the potency of antibiotics through the cylinder-plate method using parallel lines and a three-dose level model, as described in the Brazilian Pharmacopeia (4th edition, 1988), British Pharmacopoeia 2011, European Pharmacopoeia (7th edition), The International Pharmacopoeia (4th edition), and United States Pharmacopeia (34th edition). The assay is illustrated with the antibiotic ofloxacin, and details on orthogonal coefficients, normality test, homogeneity of variance test, and detection of outliers are discussed. The calculations obtained by statistical analyses from different pharmacopeias lead to the same final interpretation. In practice, with the availability of alternative pharmacopeial methods, the analyst can choose the most appropriate statistical calculation to be used.

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Kurkin, Vladimir Aleksandrovich, Tat'yana Konstantinovna Ryazanova, Anna Anatol'yevna Shmygareva, and Svetlana Nikolayevna Glushchenko. "THE DEVELOPMENT OF METHODS FOR DETERMINATION THE TOTAL OF ANTHRACENE DERIVATIVES IN RAW MATERIALS AND PREPARATIONS OF ALOE ARBORESCENS MILL." chemistry of plant raw material, no. 3 (September 27, 2021): 153–61. http://dx.doi.org/10.14258/jcprm.2021039221.

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Aloe arborescens Mill., family Asphodelaceae, is a pharmacopoeial plant, the raw material of which is used for the production of medicinal products for various therapeutic uses. The standardization of Aloe species in accordance with the requirements of the British, Japanese, European Pharmacopoeias and the United States Pharmacopoeia is carried out according to the barbaloin content by the spectrophotometric method. The methods are multistage, provide for preliminary acid hydrolysis in combination with the oxidation, liquid-liquid extraction of the formed aglycones and subsequent complexation with magnesium acetate. A mixture of isomers of aloin A and aloin B (barbaloin) and aloenin were isolated by chromatographic methods. It was determined that in all electronic spectra of the extracts and preparations from the leaves of Aloe arborescens Mill., a bathochromic shift of the long-wavelength band in the alkaline-ammonia solution is observed, which confirms the presence of anthracene derivatives. Under conditions of differential absorption, a maximum absorption is observed in the range of 412–416 nm, which indicates the advisability of using barbaloin in the analysis method, which has a maximum absorption at a wavelength of 412 nm. As a result of the study, there were developed methods for the quantitative determination of the total of anthracene derivatives in leaves and preparations of Aloe arborescens Mill. by using of the differential spectrophotometry calculated on barbaloin at an analytical wavelength of 412 nm. The content of total anthracene derivatives calculated on barbaloin was 0.60±0.03% in Aloe arborescens fresh leaves, 0.5±0.02% in freshly prepared juice, 0.135±0.006% in "Aloe juice" and 0.020±0.001% in "Aloe liquid extract", solution for subcutaneous administration, produced by ZAO "Vifitech" and OAO "Dalkhimpharm".

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Pascual, Aurélie, Maud Henry, Sébastien Briolant, Serge Charras, Eric Baret, Rémy Amalvict, Emilie Huyghues des Etages, Michel Feraud, Christophe Rogier, and Bruno Pradines. "In VitroActivity of Proveblue (Methylene Blue) on Plasmodium falciparum Strains Resistant to Standard Antimalarial Drugs." Antimicrobial Agents and Chemotherapy 55, no. 5 (February 22, 2011): 2472–74. http://dx.doi.org/10.1128/aac.01466-10.

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ABSTRACTThe geometric mean 50% inhibitory concentration (IC50) for Proveblue, a methylene blue complying with the European Pharmacopoeia, was more active on 23P. falciparumstrains than chloroquine, quinine, mefloquine, monodesethylamodiaquine, and lumefantrine. We did not find significant associations between the Proveblue IC50and polymorphisms in thepfcrt,pfmdr1,pfmdr2,pfmrp, andpfnhe-1genes or the copy numbers of thepfmdr1andpfmdr2genes, all of which are involved in antimalarial resistance.

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Reshetnikova, Irina Olegovna, Sergey Vasilievich Metlitskikh, Nadezhda Dmitrievna Stekleneva, and Aleksandr Nikolaevich Volov. "Determination of the degree of degradation of specific impurity B contained in the substance of the drug «Lomustine» by high-resolution HPLC–MS/MS method." Farmacevticheskoe delo i tehnologija lekarstv (Pharmacy and Pharmaceutical Technology), no. 6 (September 15, 2021): 56–65. http://dx.doi.org/10.33920/med-13-2112-04.

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A high-resolution HPLC–MS/MS method was proposed for the study of solutions of standards of specific impurity B contained in the substance of the drug «Lomustine», which is included in the List of Vital Medicines. A characteristic degradation product of specific impurity B, the content and quantity of which is not regulated by the European Pharmacopoeia, has been found.

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Neugodova, N. P., E. O. Stepanyuk, G. A. Sapozhnikova, E. I. Sakanyan, and M. S. Ryabtseva. "Current Approaches to the Abnormal Toxicity Test." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 10, no. 2 (June 20, 2020): 82–88. http://dx.doi.org/10.30895/1991-2919-2020-10-2-82-88.

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For over 60 years, the Abnormal Toxicity Test (ATT) has been used as an important tool in safety control of some parenteral and veterinary products made from biological materials. In 2017, some of the members of the Pharmacopoeial Committee of the Eurasian Economic Union (EAEU) proposed not to include the ATT in the draft monographs of the EAEU Pharmacopoeia based on the decision of the European Pharmacopoeia Commission to suppress the test. However, this may not be achieved in Russia at this point, because some production sites that manufacture medicinal products for human and veterinary use have not fully implemented GMP principles yet. The main aim of the ATT is to detect any toxicity above the pre-determined acceptable level. The unacceptable toxicity levels can manifest themselves in higher mortality rates or unexpected intoxication effects in laboratory animals. This test makes it possible to detect abnormal (high) toxicity of a medicinal product which may be associated with degradation products or undesirable impurities resulting from changes of the production technology, which are not mentioned in specification documents related to production, transportation, and storage. In 2016—2017 12 batches of veterinary products, including vaccines and sera, were found to be noncompliant, and the Federal Service for Surveillance in Healthcare rejected 16 batches of medicinal products in 2016—2019. The aim of the study was to analyse current approaches to the ATT in the Russian and foreign pharmacopeias, and to develop a programme for phasing out the ATT use depending on the nature and pharmacological properties of medicinal products. Comparative analysis of the monographs of the world leading pharmacopeias showed that the State Pharmacopoeia of the Russian Federation has the most stringent test conditions. As an alternative to suppressing the ATT the authors suggest a phased approach to reduce the use of this test. They determined groups of medicinal products whose pharmacological properties allow for the suppression of the test. The proposed approach to phasing out the use of ATT will make it possible to use the test effectively and reduce the number of performed tests, but will still ensure drug safety. The suppression of the ATT can not be achieved without a comprehensive detailed research by quality control specialists and further discussion by all interested parties.

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Sela, Floresha, Marija Karapandzova, Gjoshe Stefkov, and Svetlana Kulevanova. "Chemical composition of berry essential oils from Juniperus communis L. (Cupressaceae) growing wild in Republic of Macedonia and assessment of the chemical composition in accordance to European Pharmacopoeia." Macedonian Pharmaceutical Bulletin 57 (2011): 43–51. http://dx.doi.org/10.33320/maced.pharm.bull.2011.57.005.

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Chemical composition of fifteen samples of juniper essential oil was analyzed using GC/FID/MS method. Thirteen samples of berries were collected on different locations in south-western part , two of them in central-north region of Republic of Macedonia. The essential oils were obtained by hydrodistillation in a Clevenger type apparatus using official method of European Pharmacopoeia. GC/MS analysis revealed 74 identified components. The predominant fractions of the oils were monoterpene hydrocarbons representing 39.11- 73.38%. Great variability in the chemical composition and content of some components was observed. The most variable components were α-pinene (15.59-43.19%), β-pinene (1.65%-5.35%), β-myrcene (2.89%-26.50%), sabinene (2.80-11.77%), and limonene (2.90-4.46%). In the fraction of oxidized monoterpenes the most abundant was terpene-4-ol (trace - 6.32%) followed by α-terpineol (0.18-1.63%). In the sesquiterpene fraction predominant components were: germacrene D (2.76-10.22%), β-elemene (1.13-3.40%) and trans-(E)-caryophyllene (1.8%- 4.05%). Twelve samples of Macedonian juniper oils comply with European Pharmacopoeia chemical composition requirements for juniper oil and three samples did not, due to lower amount of α-pinene.

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Ücker, Annekathrin, Stephan Baumgartner, David Martin, and Tim Jäger. "Critical Evaluation of Specific Efficacy of Preparations Produced According to European Pharmacopeia Monograph 2371." Biomedicines 10, no. 3 (February 25, 2022): 552. http://dx.doi.org/10.3390/biomedicines10030552.

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European Pharmacopoeia monograph 2371 describes the production of homeopathic preparations. A specific efficacy of these preparations in high dilution levels is questionable in view of basic scientific principles. There is empirical evidence for such effects, for example in a Lemna-intoxication bioassay published 2010. To test the replicability and robustness of this bioassay, we conducted two experimental series (five independent blinded and randomised experiments each). The specimen of Lemna gibba L., clone-number 9352, were stressed in arsenic solution for 48 h (158 mg/L AsNa2HO4 (250 mg/L in series 2)), then grew in either As2O3 preparations produced according to Eu. Pharm. Monogr. 2371 or control solution. Comparing the area-related relative growth rate of day 3–9 (rgr 3–9) between treatment and control groups for each series showed differences that were not significant in series 1 (p = 0.10), significant in series 2 (p = 0.04) and significant in the pooled data of both series (p < 0.01). The effect direction (rgr 3–9 increase) was comparable to experiments of 2010, but the effect size was smaller, likely due to a changed light cycle. These results are not compatible with the hypothesis that the application of European Pharmacopoeia monograph 2371 results in pharmaceutical preparations without specific effects. Further studies are needed to investigate a potential mode of action explaining these effects.

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Dessislava Vladimirova Ilieva-Tonova, Ivanka Petkova Pencheva-El Tibi, and Assena Christova Serbezova. "UV spectrophotometric test for analysis of antihypertensive drug combinations containing amlodipine." World Journal of Advanced Pharmaceutical and Life Sciences 2, no. 1 (March 30, 2022): 001–8. http://dx.doi.org/10.53346/wjapls.2022.2.1.0036.

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The present study provides rapid test for the identity and quantification of Amlodipine besylate as monoproduct and in double and triple antihypertensive drug combinations. Test represents direct analysis - drug mixtures are analyzed in solution without prior separation using UV-VIS spectrophotometry. The spectral characteristics of the complex spectrum are used for authentication, counterfeiting, identification and assay. Basic spectral characteristics are determined and analytical parameters of the validation process are investigated. The method uses 4 types of calculations for normal and derivative spectrophotometry at different analytical zones and fixed wavelengths in the range 190 - 500 nm. For double mixtures Amlodipine / Valsartan, the best results are obtained by determining at the 1st derivative of the function, the 2nd polynomial level, the presence of 3 smoothing points, the analytical range is 190 - 400 nm, and the fixed lengths of the waves - 266 and 360 nm. For triple mixtures containing Amlodipine / Valsartan / Hydrochlorothiazide, the best results are obtained with IVth calculation type for Amlodipine and Valsartan and Ist, IIIrd and IVth for Hydrochlorothiazide. The developed method was compared with available in European Pharmacopoeia and US Pharmacopoeia methods for assay of Amlodipine substance and tablets respectively. The results show comparability and meet the pharmacopoeia criteria.

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Lagler, F., P. Hofbauer, L. Danninger, B. Hattinger, M. Aichberger, U. Mursch-Edlmayr, and W. Sperl. "P58 Development of JUNIORMED – the Austrian paediatric pharmacopoeia." Archives of Disease in Childhood 104, no. 6 (May 17, 2019): e41.1-e41. http://dx.doi.org/10.1136/archdischild-2019-esdppp.96.

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BackgroundDespite the regulatory measures to improve the availability of medicines for new-borns, infants and children, extemporaneous preparations are often necessary to cover the needs of these patients. In Austria the prescription of magistral medicines is more common (approx. 3,4% of all prescriptions) than in the European average (1,9%)1, yet a paediatric pharmacopoeia which sets standards for the preparation and use of extemporaneous preparations was missing so far.MethodsThe project was mutually conducted by the Austrian Chamber of Pharmacists, Austrian Society for Pediatric and Adolescent Medicine and the Austrian Society of General Practice/Family Medicine and funded by the Austrian Federal Ministry of Education, Science and Research (BMWFW-97.160/0001-C1/9/2015). 9.000 community and hospital pharmacists, paediatricians, dermatologists and general practitioners have been invited to submit commonly prescribed paediatric preparations. In a five step approach all submissions were assessed for completeness, pharmaceutical and medical correctness as well as level of evidence by the involved expert board (1 paediatric pharmacologist, 1 paediatrician, 4 pharmacists) and additional 10 external consultants covering 7 organ systems. Only preparations fulfilling the quality criteria for recommendation have been included in the compendium.Results1500 preparations have been submitted by 780 pharmacists, 227 general practitioners, 165 paediatricians and 3 dermatologists. 1175 were applicable for further assessment and 177 were recommended and included in the monograph compendium after assessment of correctness and level of evidence. These fell into 7 organ systems, namely 60 medicines for skin, 34 for the gastro intestinal tract, 20 for the respiratory system, 19 for CNS, 18 for ENT, 16 for circulation and kidneys, 10 for eyes.ConclusionThis project is an example of successful inter-professional cooperation with the aim to improve the quality of magistral formulations for children. The high number of excluded preparations underlines the need for quality control and standardisation.ReferenceHofbauer P. 19. GD Jahrestagung, 18. März 2015 in Berlin.Disclosure(s)Nothing to disclose

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Gray, E., A. B. Heath, B. Mulloy, J.-M. Spiese, and T. W. Barrowcliffe. "A Collaborative Study of Proposed European Pharmacopoeia Reference Preparations of Low Molecular Mass Heparin." Thrombosis and Haemostasis 74, no. 03 (1995): 893–99. http://dx.doi.org/10.1055/s-0038-1649843.

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SummaryA European collaborative study, in which 16 laboratories participated, was carried out to assess the performance of the European Pharmacopoeia (EP) monograph methods for anticoagulant activities (anti-Xa and anti-IIa assays) of low molecular mass (EMM) heparin and to assess the suitability of six candidate materials as the EP working standard for LMM heparin. There was good interlaboratory agreement for both types of assays as indicated by most gcv’s being less than 10%, indicating acceptable performance of the EP assay methods. All the candidate preparations gave dose-response curves parallel to the 1st International Standard for Low Molecular Weight heparin and to each other. All preparations, possibly with the exception of E and F, gave similar performance as measured by interlaboratory agreement and would be suitable as working standards. Based on these data, preparations A, B, C and D have been established by the EP as official EP Biological Reference Preparations and they will be issued as successive batches.

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TELLEZ, S., R. CASIMIRO, A. VELA, J. FERNANDEZGARAYZABAL, R. EZQUERRA, M. LATRE, V. BRIONES, J. GOYACHE, R. BULLIDO, and M. ARBOIX. "Unexpected inefficiency of the European pharmacopoeia sterility test for detecting contamination in clostridial vaccines." Vaccine 24, no. 10 (March 6, 2006): 1710–15. http://dx.doi.org/10.1016/j.vaccine.2005.12.037.

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Sitaramaraju, Yarramraju, Adil Riadi, Ward D’Autry, Kris Wolfs, Jos Hoogmartens, Ann Van Schepdael, and Erwin Adams. "Evaluation of the European Pharmacopoeia method for control of residual solvents in some antibiotics." Journal of Pharmaceutical and Biomedical Analysis 48, no. 1 (September 2008): 113–19. http://dx.doi.org/10.1016/j.jpba.2008.05.015.

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Schwanig, M., Margit Nagel, Karin Duchow, and Beate Krämer. "Elimination of abnormal toxicity test for sera and certain vaccines in the European Pharmacopoeia." Vaccine 15, no. 10 (July 1997): 1047–48. http://dx.doi.org/10.1016/s0264-410x(97)00074-1.

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Schlags, Wolfgang, Bodo Lachmann, Michael Walther, Martin Kratzel, and Christian R. Noe. "Two-dimensional electrophoresis of recombinant human erythropoietin: A future method for the European Pharmacopoeia?" PROTEOMICS 2, no. 6 (June 2002): 679–82. http://dx.doi.org/10.1002/1615-9861(200206)2:6<679::aid-prot679>3.0.co;2-f.

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Journal articles on the topic 'European Pharmacopoeia'

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