ChP refers to the Pharmacopoeia of the People’s Republic of China (Chinese Pharmacopoeia). ChP is China’s official collection of standards for drug development, production, sales, utilization, supervision, and control.
ChP is updated by the Chinese Pharmacopoeia Commission every five years. The latest version is the ChP 2020, of which the API & excipient standards are listed in this database.
In China, all drugs shall comply with the ChP standards to obtain marketing authorization. Therefore, it’s necessary for drug applicants to understand and meet the standards.
The API standards generally include the following items: (1) name (Chinese name, Pinyin, and English name); (2) structural formula of organic drugs; (3) molecular formula and molecular weight; (4) sources or chemical name of organic drugs; (5) content or potency; (6) formulation; (7) production; (8) description; (9) identification; (10) test; (11) assay of content or potency; (12) category; (13) strength; (14) storage; (15) preparation; (16) label; (17) impurity information, etc.
The excipient standards generally include: (1) name (Chinese name, Pinyin, and English name); (2) structural formula of organics; (3) molecular formula, molecular weight, and CAS number; (4) sources; (5) production; (6) description; (7) identification; (8) test; (9) assay of content; (10) category; (11) storage; (12) label; (13) appendices and notes, etc.
The standards sent to you are English translations.