ABSTRACT
OBJECTIVE: To summarize 2017 edition of British Pharmacopoeia, and to facilitate the use of it by drug inspectors. METHODS: The main contents and layout of 2017 edition of British Pharmacopoeia were overviewed; the similarities and differences between Chinese Pharmacopoeia and British Pharmacopoeia were described by means of literature research and general comparison with the 2015 edition of Chinese Pharmacopoeia. The reference for Chinese Pharmacopoeia was put forward. RESULTS & CONCLUSIONS: British Pharmacopoeia includes 7 parts as "introduction" "explanatory notes" "text variety" "infrared control chromatogram", and divided into 6 volumes, such as "pharmaceutical raw materials" "formulated preparations" "veterinary drugs". Compared with the previous edition, 2017 edition added 69 new varieties, removed 9 monographs and modified 91 varieties technologically. Compared with Chinese Pharmacopoeia, British Pharmacopoeia additionally included veterinary drugs, homeopathic preparations, surgical materials, infrared spectrogram, etc. Compared with the update of Chinese Pharmacopoeia every 5 years, British Pharmacopoeia Commission updated and revised the British Pharmacopoeia every year, and provided reliable reference for the establishment of scientific analysis methods in time. At the same time, British Pharmacopoeia Commission established British Pharmacopoeia online website www. pharmacopoeia. com to provide a more convenient and fast platform for users; British Pharmacopoeia Commission paid special attention to maintaining close ties with drug manufacturers, regulators, the European Medicines Agency (EMA) and the Chinese Herbal Medicine Products Committee in EMA so as to revise drug standards timely. It provides enlightenment and reference for the revision of Chinese Pharmacopoeia.
ABSTRACT
OBJECTIVE:To provide ideas for revise and improve the standard and related method of the quality control of ben-zalkonium chloride in Chinese Pharmacopoeia (2015 edition,Ⅱ). METHODS:The standards and related methods of the quality control of benzalkonium chloride in Chinese Pharmacopoeia(2015 edition,Ⅱ),British Pharmacopoeia(2013 edition),European Pharmacopoeia (7.0 edition) and United States Pharmacopoeia (36 edition) were comprehensively compared. RESULTS:Com-pared with Chinese Pharmacopoeia(2015 edition,Ⅱ),the standards abroad provided the component and the ratio of the benzalko-nium chloride substituted homolog,the method for ammonia compound test had higher sensibility,it also added the test for benzyl alcohol,benzaldehyde and benzyl chloride impurity,as well as the component ratio test and average relative molecular mass calcu-lation. CONCLUSIONS:The standard and related method of the quality control of benzalkonium chloride in Chinese Pharmacopoe-ia(2015 edition,Ⅱ)still need to be further improved.
ABSTRACT
The paper presents a detailed review of British pharmaceutical standards including British Pharma-copoeia, European Pharmacopoeia, British Approved Names, Reference Standards and Non-Statutory Pharmaceutical Standards. British pharmaceutical standards are established by the British Pharmacopoeia Commission, Expert Advi-sory Groups, Panels of Experts and Working Parties, British Pharmacopoeia Commission Secretariat, British Pharma-copoeia Laboratory, and standard-setting procedures are clear and definite. British Pharmacopoeia standards are le-gally binding, and pharmaceutical products sold in the United Kingdom must comply with pharmacopoeia require-ments. British pharmaceutical standards can serve as an important reference for reforms to China’s pharmaceutical standards, including the scientific management of pharmaceutical standards, the improvement of organizational frame-works in the establishment pharmaceutical standards, the promptness of amendments to pharmacopoeia, and the uni-versality of international exchanges.