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Chinese Pharmacopoeia 2010 Pdf



Chinese Pharmacopoeia 2010 Pdf: A Comprehensive Review




The Chinese Pharmacopoeia (CP) is the official compendium of standards for the quality and safety of drugs in China. It covers various types of drugs, such as chemical drugs, antibiotics, biochemical drugs, radioactive drugs, biological products, traditional Chinese medicines, excipients and packaging materials. The CP is revised and published every five years by the Chinese Pharmacopoeia Commission (CPC), which is affiliated with the National Medical Products Administration (NMPA).




Chinese Pharmacopoeia 2010 Pdf



The latest edition of the CP is the 2010 edition, which was published in July 2010 and came into effect on July 1, 2011. It consists of four volumes: Volume I for chemical drugs, antibiotics, biochemical drugs and radioactive drugs; Volume II for traditional Chinese medicines and traditional Chinese patent medicines; Volume III for biological products; and Volume IV for general rules, excipients and packaging materials. The CP 2010 contains a total of 4,727 monographs, including 628 new monographs, 2,661 revisions and 42 rejections.


Volume I: Chemical Drugs, Antibiotics, Biochemical Drugs and Radioactive Drugs




Volume I contains a total of 2,603 monographs of chemical drugs, antibiotics, biochemical drugs and radioactive drugs, including 492 new monographs, 415 revisions and 28 rejections. The new monographs include some new chemical entities that have been approved by the NMPA in recent years, such as apixaban, dabigatran etexilate, rivaroxaban, sitagliptin phosphate and vildagliptin. The revisions mainly involve the improvement of analytical methods and specifications for impurities and related substances. The rejections are mainly due to the withdrawal of marketing authorization or obsolescence of some drugs.


Volume I also contains 36 general chapters that provide general rules and guidance for the quality control of chemical drugs, antibiotics, biochemical drugs and radioactive drugs. Some of the general chapters are harmonized with the International Conference on Harmonisation (ICH) guidelines or other pharmacopoeias, such as the European Pharmacopoeia (EP) and the United States Pharmacopeia (USP). For example, the general chapter on genotoxic impurities refers to the ICH Q3B guideline; the general chapter on dissolution test refers to the EP chapter 2.9.3; and the general chapter on uniformity of dosage units refers to the USP chapter .


Volume II: Traditional Chinese Medicines and Traditional Chinese Patent Medicines




Volume II contains a total of 1,358 monographs of traditional Chinese medicines (TCMs) and traditional Chinese patent medicines (TCPMs), including 23 new monographs, 727 revisions and eight rejections. The new monographs include some rare or endangered medicinal materials that have been newly discovered or cultivated in China, such as Cordyceps sinensis, Ganoderma lucidum and Panax notoginseng. The revisions mainly involve the improvement of identification methods and specifications for heavy metals, microbial limits


to the WHO guideline on sterility testing of biological products; the general chapter on bacterial endotoxins test refers to the EP chapter 2.6.14; and the general chapter on mycoplasma test refers to the USP chapter .


Volume IV: General Rules, Excipients and Packaging Materials




Volume IV contains 36 general chapters that provide general rules and guidance for the quality control of drugs in general, such as the general requirements for preparations, the general testing methods and the guidelines for stability studies. Some of the general chapters are harmonized with the ICH guidelines or other pharmacopoeias, such as the EP and the USP. For example, the general chapter on stability testing of new drug substances and products refers to the ICH Q1A guideline; the general chapter on validation of analytical procedures refers to the ICH Q2 guideline; and the general chapter on residual solvents refers to the EP chapter 2.4.24.


Volume IV also contains 277 monographs of excipients and packaging materials, including 65 new monographs, 212 revisions and four rejections. The new monographs include some new excipients that have been widely used in drug formulations, such as crospovidone, hypromellose acetate succinate and polysorbate 80. The revisions mainly involve the improvement of identification methods and specifications for functional properties and safety. The rejections are mainly due to the withdrawal of marketing authorization or obsolescence of some excipients and packaging materials.


The CP 2010 is available in both Chinese and English versions. The Chinese version is the official and authoritative version, while the English version is for reference only. The CP 2010 can be purchased in print or electronic format from the CPC or its authorized distributors. The CP 2010 can also be accessed online through the CPC website or the NMPA website.


The CP 2010 is widely used by drug manufacturers, regulators, researchers, educators and health professionals in China and abroad. It provides the essential standards and guidance for ensuring the quality and safety of drugs in China. It also reflects the latest achievements and developments of drug science and technology in China and the world. It contributes to the harmonization and coordination of drug standards among different countries and regions.


The CPC is currently working on the preparation of the next edition of the CP, which is expected to be published in 2020. The CPC welcomes any suggestions and feedback from the users and stakeholders of the CP. The CPC also invites any interested parties to participate in the revision and formulation of the CP standards. The CPC hopes to make the CP more comprehensive, scientific, rational and precise, and to better serve the public health and drug industry in China and the world.


The Chinese Pharmacopoeia 2010 Pdf is a valuable resource for anyone who is interested in the quality and safety of drugs in China. It provides the official and authoritative standards and guidance for the quality control of various types of drugs, such as chemical drugs, biological products, traditional Chinese medicines and excipients. It also covers the general rules and testing methods for the quality control of drugs in general.


The Chinese Pharmacopoeia 2010 Pdf is based on the latest scientific and technological achievements and developments in the field of drug science and technology. It also incorporates the relevant requirements and guidelines of the international organizations and other pharmacopoeias, such as the WHO, the ICH, the EP and the USP. It aims to ensure the quality and safety of drugs in China and to promote the harmonization and coordination of drug standards among different countries and regions.


The Chinese Pharmacopoeia 2010 Pdf is available in both Chinese and English versions. The Chinese version is the official and authoritative version, while the English version is for reference only. The Chinese Pharmacopoeia 2010 Pdf can be purchased in print or electronic format from the CPC or its authorized distributors. The Chinese Pharmacopoeia 2010 Pdf can also be accessed online through the CPC website or the NMPA website.


The Chinese Pharmacopoeia 2010 Pdf is the result of the hard work and dedication of the CPC and its members, who are experts and representatives from various fields and sectors related to drug science and technology. The CPC is responsible for the revision and publication of the CP every five years. The CPC also welcomes any suggestions and feedback from the users and stakeholders of the CP. The CPC also invites any interested parties to participate in the revision and formulation of the CP standards.


The Chinese Pharmacopoeia 2010 Pdf is not only a compendium of standards, but also a reflection of the history and culture of China. It contains the rich and diverse knowledge and experience of traditional Chinese medicine, which has been developed and accumulated for thousands of years. It also shows the innovation and progress of modern drug science and technology in China, which has been achieved through the reform and opening-up policy and the rapid economic and social development in China.


The Chinese Pharmacopoeia 2010 Pdf is not only a tool for ensuring the quality and safety of drugs in China, but also a bridge for connecting and communicating with the international drug community. It facilitates the exchange and cooperation of drug science and technology among different countries and regions. It also contributes to the public health and drug industry in China and the world.


In conclusion, the Chinese Pharmacopoeia 2010 Pdf is a comprehensive and authoritative compendium of standards for the quality and safety of drugs in China. It covers various types of drugs, such as chemical drugs, biological products, traditional Chinese medicines and excipients. It also provides general rules and guidance for the quality control of drugs in general. It is based on the latest scientific and technological achievements and developments in the field of drug science and technology. It also incorporates the relevant requirements and guidelines of the international organizations and other pharmacopoeias. It aims to ensure the quality and safety of drugs in China and to promote the harmonization and coordination of drug standards among different countries and regions. It is a valuable resource for anyone who is interested in the quality and safety of drugs in China. It is also a reflection of the history and culture of China, a bridge for connecting and communicating with the international drug community, and a contribution to the public health and drug industry in China and the world.


If you want to learn more about the Chinese Pharmacopoeia 2010 Pdf, you can visit the official website of the CPC or the NMPA. You can also download the Chinese Pharmacopoeia 2010 Pdf for free from the web of pharma website. You can also purchase the Chinese Pharmacopoeia 2010 Pdf in print or electronic format from the CPC or its authorized distributors. You can also access the Chinese Pharmacopoeia 2010 Pdf online through the CPC website or the NMPA website.


The Chinese Pharmacopoeia 2010 Pdf is a useful and reliable source of information for anyone who is involved or interested in the quality and safety of drugs in China. It provides the official and authoritative standards and guidance for the quality control of various types of drugs, such as chemical drugs, biological products, traditional Chinese medicines and excipients. It also provides general rules and guidance for the quality control of drugs in general. It is based on the latest scientific and technological achievements and developments in the field of drug science and technology. It also incorporates the relevant requirements and guidelines of the international organizations and other pharmacopoeias. It aims to ensure the quality and safety of drugs in China and to promote the harmonization and coordination of drug standards among different countries and regions.


The Chinese Pharmacopoeia 2010 Pdf is not only a compendium of standards, but also a reflection of the history and culture of China. It contains the rich and diverse knowledge and experience of traditional Chinese medicine, which has been developed and accumulated for thousands of years. It also shows the innovation and progress of modern drug science and technology in China, which has been achieved through the reform and opening-up policy and the rapid economic and social development in China.


The Chinese Pharmacopoeia 2010 Pdf is not only a tool for ensuring the quality and safety of drugs in China, but also a bridge for connecting and communicating with the international drug community. It facilitates the exchange and cooperation of drug science and technology among different countries and regions. It also contributes to the public health and drug industry in China and the world.


In summary, the Chinese Pharmacopoeia 2010 Pdf is a comprehensive and authoritative compendium of standards for the quality and safety of drugs in China. It covers various types of drugs, such as chemical drugs, biological products, traditional Chinese medicines and excipients. It also provides general rules and guidance for the quality control of drugs in general. It is based on the latest scientific and technological achievements and developments in the field of drug science and technology. It also incorporates the relevant requirements and guidelines of the international organizations and other pharmacopoeias. It aims to ensure the quality and safety of drugs in China and to promote the harmonization and coordination of drug standards among different countries and regions. It is a valuable resource for anyone who is interested in the quality and safety of drugs in China. It is also a reflection of the history and culture of China, a bridge for connecting and communicating with the international drug community, and a contribution to the public health and drug industry in China and the world. d282676c82


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