Academic literature on the topic 'British pharmacopoeia'

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Journal articles on the topic "British pharmacopoeia"

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Sidani, S. A. "British Homoeopathic Pharmacopoeia." British Homeopathic Journal 84, no. 01 (January 1995): 63. http://dx.doi.org/10.1016/s0007-0785(05)80740-9.

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Jordan, Sue. "British Pharmacopoeia (BP) 2011British Pharmacopoeia (BP) 2011." Nursing Standard 25, no. 46 (July 20, 2011): 31. http://dx.doi.org/10.7748/ns2011.07.25.46.31.b1235.

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Keen, P. "British pharmacopoeia (veterinary) 1985." British Veterinary Journal 142, no. 5 (September 1986): 489. http://dx.doi.org/10.1016/0007-1935(86)90058-8.

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Kennard, Colin. "CD-ROM Containing British Pharmacopoeia and British Pharmacopoeia (Veterinary) from HMSO Electronic Publishing, England." Journal of Chemical Information and Modeling 35, no. 4 (July 1, 1995): 780. http://dx.doi.org/10.1021/ci00026a601.

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Chavan, Harishchandra, Gurmeet Chhabra, Nayan Gujarathi, and Anil Jadhav. "Comparative study of In-process and finished products quality control test for tablet and capsules according to pharmacopoeias." Asian Journal of Pharmaceutical Research and Development 6, no. 3 (July 10, 2018): 60–68. http://dx.doi.org/10.22270/ajprd.v6i3.370.

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The goal of all Pharmaceutical industry is to make a good quality product and for this it is necessary to allow In-Process Quality Control (IPQC) Approaches. In-process quality control tests are done before the manufacturing process is completed. The function of in-process controls is to monitor and if necessary, adaptation of the manufacturing process to achieve the required specification. This may incorporate control of equipment and environment too. In-process materials should be tested for their physical parameters and its quality attributes which are later approved or rejected by the quality control department. The reason of IPQC is to deliver a cumulative finished product by avoiding or eliminating mistakes at every stage in production. The objective of this study is the comparison of In-process quality control test of India Pharmacopoeia, British Pharmacopoeia and the United state Pharmacopoeia. It was observed from various studies that quality control tests for tablet and capsule listed in different pharmacopoeias have slight similarities and differences
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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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Olakojo, Oluwatobi O., and Isah S. Usman. "In vitro quality evaluation of brands of promethazine tablets marketed in Edo State, Nigeria." Journal of Pharmacy & Bioresources 18, no. 2 (September 6, 2021): 113–21. http://dx.doi.org/10.4314/jpb.v18i2.4.

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The increasing number of multisource pharmaceuticals has necessitated the need for continuous quality assessment of products available for atients’ consumption. Promethazine is an anti-histamine used in cases of nausea, vomiting, motion sickness etc. The study was to examine the in vitro quality parameters for ten brands of promethazine hydrochloride tablets sold in retail pharmacies in Edo State, Nigeria. The parameters determined were identification, weight variation, friability, hardness, disintegration, dissolution rate and assay. All samples were evaluated for conformity with British Pharmacopoeia (BP) 2017 standards. Results obtained showed tablet weight ranging from 0.08 g ± 1.77 % to 0.255 g ± 3.557 %, hardness from 4.36 ± 0.58 to 8.33 ± 3.21 kg/cm2, friability of < 1 %, disintegration time of 2.47 ± 0.90 to 69.66 ± 7.23 min and assay of 61.32 ± 2.04 to 183.19 ± 0.11%. The ten batches but one released more than 80 % of their drug content within 30 min. Analysis of similarity factor revealed other samples but PR-7 can be interchangeable with PR-1 based on dissolution profile. The results showed that not all samples examined passed all the pharmacopoeia tests for satisfactory quality. Thus, they all cannot be used interchangeably in clinical practice. Keywords: Promethazine; Quality Control; Dissolution; Pharmacopoeial specifications
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DEMBELE, Ousmane, Bakary Moussa Cissé, Mody Cissé, Seydou Moussa Coulibaly, Jacques Dakouo, Nana Houmama Cissé, and Benoît Yaranga Koumaré. "Evaluation of the quality of the main antimicrobial drugs sold in pharmacies in Bamako (Mali) according to a risk-based sampling." Journal of Drug Delivery and Therapeutics 12, no. 3-S (June 15, 2022): 154–59. http://dx.doi.org/10.22270/jddt.v12i3-s.5401.

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Objectives: In a world marked by the increase in chemoresistance leading to the adoption of therapeutic combinations, the advent of generic multi-source drugs, the spread of counterfeiting and substandard drugs, often without active ingredients or falsified active ingredients, a greater vigilance by pharmaceutical regulatory authorities is needed. Drug quality control therefore plays an important role in detecting poor quality products on the market. Antimicrobial resistance (AMR) is a growing threat to public health. It occurs when vital antimicrobials can no longer effectively treat bacteria and other microbes. Worldwide, around 700,000 people die each year due to antimicrobial resistance and without global action it could lead to 10 million deaths a year by 2050. This study aimed to assess the quality of major antimicrobials sold in Bamako to determine the prevalence of falsified and substandard antimicrobials. Methods: Samples were taken in some pharmacies in Bamako and analyzed according to the standards of the United State Pharmacopoeia (USP), British Pharmacopoeia (BP) and International Pharmacopoeia (IP) by identification and assay methods. Products that do not meet the required specifications described by these pharmacopoeias are declared non-compliant. Results: A total of 151 samples were taken according to a protocol based on the risks, of which 145 were compliant and 6 non-compliant due to an under-dosage of active ingredient. We found 58% of unregistered drugs that came from India and China. Conclusion: This study allowed us to detect 6 non-compliant products that were withdrawn from the market and regulatory measures were taken. Keywords: Antimicrobial, quality control, non-compliance, AMR.
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Mashin, V. V., A. N. Sergeev, N. N. Martynova, T. V. Antipina, E. I. Sakanyan, V. V. Kataeva, and N. V. Zagidullin. "Minimisation of the viral contamination risk of heterologous immunoglobulins in the context of the requirements of the State Pharmacopoeia of the Russian Federation." Biological Products. Prevention, Diagnosis, Treatment 22, no. 2 (June 2, 2022): 112–23. http://dx.doi.org/10.30895/2221-996x-2022-22-2-112-123.

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To ensure the safety and to secure the approval of injectable medicinal products based on antigen-specific immunoglobulins of animal origin, it is necessary to exclude their contamination with adventitious human pathogens. Ensuring the viral safety of heterologous immunoglobulins presents a major challenge, because the State Pharmacopoeia of the Russian Federation, 14 edition, lacks production stage-specific viral safety requirements for such medicinal products. The aim of the study was to analyse the requirements set forth in general and individual monographs of the State Pharmacopoeia of the Russian Federation, the European Pharmacopoeia, (10th edition), the British Pharmacopoeia (2019), the United States Pharmacopoeia (USP 43–NF 38), the Japanese Pharmacopoeia (17th edition), as well as the recommendations of the European Medicines Agency and the World Health Organisation concerning the viral safety of medicinal products for human use based on heterologous antigen-specific immunoglobulins. The authors analysed regulatory requirements for the following: serum/plasma-producing animals; immunisation antigens for the animals; quarantine of the animals; viral contamination tests for immune animal serum/plasma pools; model viruses to validate viral inactivation/removal processes at different stages of vaccine production; viral load reduction at each inactivation/ removal step; testing of materials obtained at critical production stages. The authors drafted sections for quality standards on production stage-specific measures to minimise the viral contamination risk of medicinal products for human use based on heterologous immunoglobulins, which they proposed for inclusion to the State Pharmacopoeia of the Russian Federation.
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Patel, S. S., M. S. Patel, and N. M. Patel. "Flowability Testing of Directly Compressible Excipients According to British Pharmacopoeia." Journal of Pharmaceutical Research 8, no. 2 (April 1, 2009): 66. http://dx.doi.org/10.18579/jpcrkc/2009/8/2/79756.

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Dissertations / Theses on the topic "British pharmacopoeia"

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Brits, Ilene. "International pharmacopoeia monographs for zinc acetate and zinc gluconate active pharmaceutical ingredients used in the treatment of paediatric diarrhoea / Brits I." Thesis, North-West University, 2012. http://hdl.handle.net/10394/8088.

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Acute diarrhoea is one of the largest health challenges globally, causing millions of child deaths every year. A continued effort is made by the WHO, in collaboration with other institutions, to successfully combat diarrhoea. A new formulation for ORS (with a reduced osmolarity), in combination with zinc supplementation, was proposed to reduce the severity and duration of diarrhoea (WHO, 2006:1). Appropriate zinc supplementation for the treatment of diarrhoea includes: zinc sulfate, zinc acetate dihydrate and zinc gluconate. With no monographs available in The Ph. Int. for zinc acetate dihydrate and zinc gluconate APIs, the development thereof has become a priority to the WHO. During this study, suitable methods according to The Ph. Int. for the quality control testing of zinc acetate dihydrate and zinc gluconate APIs were investigated and proposed. The following monograph requirements were proposed for zinc acetate dihydrate API: * Identification of zinc by means of a precipitation reaction of zinc hydroxide and zinc sulfide, * Identification of acetate by means of a precipitation reaction of ferric acetate, * Clarity and colour of a 0.05 g/ml solution, * pH value of a 0.05 g/ml solution, * Assay by means of a complexometric titration with disodium EDTA, * Impurities / Limit tests: o reducing substances by means of a reduction reaction with potassium permanganate, o chlorides by means of a precipitation reaction with silver nitrate, o sulfates by means of a precipitation reaction of barium sulfate, o arsenic by means of reaction between arsine and bromide, o aluminium, cadmium, copper, iron and lead by means of atomic absorption spectrometry. The following monograph requirements were proposed for zinc gluconate API: * Identification of zinc by means of a precipitation reaction of zinc ferrocyanide, * Identification of gluconate by means of a thin layer chromatographic separation method, * Clarity and colour of a 0.01 g/ml solution, * pH value of a 0.01 g/ml solution, * Water by means of the Karl Fischer method, * Assay by means of a complexometric titration with disodium EDTA, * Impurities / Limit tests: o reducing sugars by means of a reduction reaction with cupri–tartaric test solution, o chlorides by means of a precipitation reaction with silver nitrate, o sulfates by means of a precipitation reaction of barium sulfate, o heavy metals by means of a precipitation reaction of sulfides in acidic solutions, o cadmium by means of atomic absorption spectrometry, and o microbial testing if required by The Ph. Int. The proposed methods were then validated or verified according to international standards. Once the methods were proven to be fit for purpose, they were assembled into the respective monographs for inclusion in The Ph. Int. The newly developed monographs were then evaluated by determining the compliance of commercially available zinc acetate dihydrate and zinc gluconate to the proposed specifications. The study contributes to the WHO, pharmaceutical industry and medicines regulatory authorities by making these two monographs globally available, thus providing a quality gauge to ensure the availability of zinc acetate dihydrate and zinc gluconate APIs of pharmaceutical acceptable quality.
Thesis (MSc (Pharmaceutics))--North-West University, Potchefstroom Campus, 2012.
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Books on the topic "British pharmacopoeia"

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Britain), Stationery Office (Great. British pharmacopoeia 2009. London: Stationery Office, 2008.

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HMSO. British pharmacopoeia 2005. London: The Stationery Office, 2005.

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Britain), Stationery Office (Great. British Pharmacopoeia 2008. London: Stationery Office, 2007.

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Great Britain. Department of Health., ed. British pharmacopoeia (veterinary) 1985. London: H.M.S.O., 1993.

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Bernan. British Pharmacopoeia 2003 & British Pharmacopoeia Veterinary (British Pharmacopoeia). Bernan Assoc, 2003.

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Bernan. British Pharmacopoeia 2003 & British Pharmacopoeia Veterinary (British Pharmacopoeia). Bernan Assoc, 2003.

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British. British Pharmacopoeia 2005 (British Pharmacopoeia). Not Avail, 2005.

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Commission, British Pharmacopoeia. British Pharmacopoeia 2004 (British Pharmacopoeia). Stationery Office Books (TSO), 2004.

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Commission, British Pharmacopoeia. British Pharmacopoeia 2004 (British Pharmacopoeia). Stationery Office Books (TSO), 2004.

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HMOS. British Pharmacopoeia: Veterinary Amendment (British Pharmacopoeia). Bernan Press, 1986.

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Book chapters on the topic "British pharmacopoeia"

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"British Pharmacopoeia and the European Pharmacopoeia." In The British Pharmacopoeia, 1864 to 2014, 161–72. Routledge, 2016. http://dx.doi.org/10.4324/9781315614182-15.

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"The Earlier British National Pharmacopoeias." In The British Pharmacopoeia, 1864 to 2014, 25–50. Routledge, 2016. http://dx.doi.org/10.4324/9781315614182-10.

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"International Harmonisation of Pharmacopoeias." In The British Pharmacopoeia, 1864 to 2014, 173–84. Routledge, 2016. http://dx.doi.org/10.4324/9781315614182-16.

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"Early Years: 1864–1914." In The British Pharmacopoeia, 1864 to 2014, 51–68. Routledge, 2016. http://dx.doi.org/10.4324/9781315614182-11.

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"Middle Years: 1914–1968." In The British Pharmacopoeia, 1864 to 2014, 69–114. Routledge, 2016. http://dx.doi.org/10.4324/9781315614182-12.

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"Later Years: 1968–2014." In The British Pharmacopoeia, 1864 to 2014, 115–58. Routledge, 2016. http://dx.doi.org/10.4324/9781315614182-13.

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"Changes in Therapeutics 1864–2014." In The British Pharmacopoeia, 1864 to 2014, 187–226. Routledge, 2016. http://dx.doi.org/10.4324/9781315614182-18.

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"Changes in Analytical Methods 1864–2014." In The British Pharmacopoeia, 1864 to 2014, 227–54. Routledge, 2016. http://dx.doi.org/10.4324/9781315614182-19.

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"The European Directorate for the Quality of Medicines and HealthCare, European Pharmacopoeia, and British Pharmacopoeia." In Pharmaceutical Medicine, edited by Adrian Kilcoyne, Phil Ambery, and Daniel O'Connor, 34–36. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780199609147.003.0010.

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"The Regulation of Biological and other Innovative Medicinal Products." In The Law and Regulation of Medicines and Medical Devices, edited by Anne Cook, John Johnston, and Louise Bisset, 60–86. Oxford University Press, 2021. http://dx.doi.org/10.1093/oso/9780192847546.003.0003.

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This chapter discusses the phrase ‘biological medicinal product’, which is used to refer to products manufactured by biological or biotechnology means or to advanced therapy medicinal products. It examines biological medicinal products that are considered peptides or proteins and are made up of one or more linear sequences of amino acids. It also talks about the compliance of biological products with a minimum quality standard set by the British Pharmacopoeia or European Pharmacopoeia, which includes specific instructions for testing sterility, bacterial endotoxins, microbial limits, volume in container, uniformity of dosage units, and particulate matter. The chapter highlights biological products that are manufactured using recombinant cells and are extracted or made from unaltered tissues or blood that are purified in the same way as recombinant products. It explores the inherent heterogeneity of biological products as it comprises of a mixture of closely related molecules.
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