The Chinese Pharmacopoeia 2010 English Edition Free 111: A Unique and Comprehensive Collection of Ch

In the Chinese "Pharmacopoeia of the People's Republic of China" - 9th edition (2010, English Version, ChP) you can find the provisions on dissolution testing. Unfortunately, the dissolution method described in the ChP isn't completely harmonised with the USP, Ph. Eur or the Japanese Pharmacopeia (JP). Compared to the USP for example, there are significant differences in:

The Chinese Pharmacopoeia 2010 English Edition Free 111

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2.5. Interference of the Aqueous Phase Extraction Solution. As the ultrapure paraffin oil is water insoluble oily liquid, its endotoxin must be water-extracted before analysis can be made. In order to determine possible interference factors, 10 mL ultrapure paraffin oil was mixed with 10 mL endotoxin-free water and shaken for 15 min at 2000 rpm. The bottom aqueous phase was then diluted twice with endotoxin-free water followed by endotoxin analysis according to the regulation of the Chinese Pharmacopoeia 2010, Appendix II, "The bacterial endotoxin test sample for the interference test" [5]. Control standard endotoxins were prepared at different concentrations, 0.25, 0.125, 0.06, and 0.03 EU/mL, with endotoxin-free water. The endotoxin-free water and the twice diluted water phase were used as negative controls. Tachypleus Amebocyte Lysate preparations with a sensitivity of 0.125 EU/mL from two different suppliers were applied for comparison.

2.7. Analysis of the Concentration of Bacterial Endotoxin in the Ultrapure Paraffin Oil. 10 mL endotoxin-free water was added to 10 mL sample followed by shaking for 15 min at 2000 rpm. The bottom aqueous phase was then analysed for endotoxin according to the gel-clot method of the Chinese Pharmacopoeia 2010, appendix XIE. The endotoxin level must be lower than 0.25 EU/mL. Bacterial endotoxin analysis of twice diluted extracts was performed using a Tachypleus Amebocyte Lysate with a sensitivity of 0.125 EU/mL [6, 7].

Raw PR (Supplementary Fig. 1), originated from Sichuan province (China), was provided by Kangmei Pharmaceutical Co. Ltd. Alumen was purchased from Jiangxi Zhangshu Tianqitang Traditional Chinese Medicine Co. Ltd. They were authenticated in accordance with the corresponding monograph in CP2010 (2010 edition of CP) by Dr. Hui Cao from Jinan University, China. Voucher specimens of raw PR (No. 20130510) and alumen (No. 1307007) were deposited at the School of Chinese Medicine, Hong Kong Baptist University.

The history of the Indian Pharmacopoeia (IP) (11) began in 1833, when a committee recommended publication of a pharmacopoeia, which was first completed in 1844 and mainly consisted of commonly used indigenous remedies. A subsequent publication in 1868 included not only the indigenous drugs used in India, but also the drugs of the British Pharmacopoeia. Then in 1885, the BP was made official in India. After independence from Britain, the Indian Pharmacopoeia Commission was established in 1948, with its main function being the publication of IP as the national pharmacopoeia. The first edition of the modern IP was published in 1955, and the current 8th edition was published in 2018.

Elsewhere, the first edition of the Russian Pharmacopoeia (now the State Pharmacopoeia of the Russian Federation or SP RF) dates back to 1866 (12); it is now in its 14th edition, which was published (in Russian and on-line only) by the Russian Ministry of Health in December 2018, with implementation required by January 2022. The Japanese Pharmacopoeia (JP) was first published in 1886 (13) and is now in its 17th edition including two supplements, with the 18th edition planned for publication in 2021. The pharmacopoeias in Mexico and Argentina were first published in 1846 and 1898, respectively (1). The first edition of the Brazilian Pharmacopoeia was published in 1929 (1) and is currently in its 5th edition including two supplements, with an updated 6th edition nearing completion. The Korean Pharmacopoeia was first published in 1958 (1); the Indonesian Pharmacopoeia in 1962 (12). Other recent examples include the pharmacopoeias in Vietnam, Thailand, the Philippines, and Kazakhstan, first published in 1970, 1987, 2004, and 2008, respectively (1).

In their historical context, the development of the USP and BP were intended to harmonize drug standards. But unlike the USP, BP, and many other pharmacopoeias, the more recent creation of the Ph. Eur. occurred within the context of modern manufacturing and regulatory systems in Europe and around the world, providing a recent and successful example of harmonization. In 1964, the Convention on the Elaboration of a European Pharmacopoeia, set forth by eight member states of the Council of Europe, established harmonized standards for medicines in Europe (5). The convention facilitated the free movement of medicines throughout member states and ensured access to medicines by European citizens. Today, this convention has 39 signatory parties from Europe, including the European Union, in which there is mandatory compliance with the requirements of the Ph. Eur. These member states participate and vote in the European Pharmacopoeia Commission sessions, where the standards published in the Ph. Eur. are adopted (14). Currently, there are also 30 observers from all over the world, including the US, China, and WHO, that are able to participate in the scientific work of the Commission and benefit from the European experience in this area. Observers also gain access to the work on the quality control of medicines and the methods of analysis in the Ph. Eur., which could further support compendial harmonization through adoption or adaptation of the Ph. Eur. standards.

In 1947, WHO took over the work begun under the League of Nations for the unification of pharmacopoeias. The first edition of the Ph. Int. was published in two volumes (1951 and 1955) and a supplement (1959) in English, French, and Spanish, and also translated into German and Japanese. The Ph. Int. was originally published with the aim of creating a worldwide, unified pharmacopoeia and relied on collaboration with national pharmacopoeia commissions for its preparation. However. it was recommended that Ph. Int. was not intended to be a legal pharmacopoeia in any country unless adopted by the pharmacopoeial authority of that country. In 1975, the purpose of the Ph. Int. was reconsidered. It was decided that the publication should focus more on the needs of developing countries, applying simple, classical chemical techniques for the testing of medicines. Priority would be given to drugs that were widely used throughout the world, with emphasis on the therapeutic value of these drugs. High priority would be accorded to drugs important to WHO health programs, and to those likely to contain impurities arising from degradation or due to difficulties in their manufacture. Since 1979, monographs in Ph. Int. have provided specifications for the identification, purity and content for drugs in the WHO Model List of Essential Medicines. 2ff7e9595c