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If a drug substance is not included in monographing pharmacopeia, what are the requirements for the drug substance specification?

刊登日期:2020-07-22  |  點閱次數 : 759 次 

If a drug substance is not included in monographing pharmacopeia, what are the requirements for the drug substance specification?

  1. 1. If a monograph for a drug substance is not published in the pharmacopeia of the ten medically advanced countries, then the drug substance specification may be established by referencing relevant ICH guidelines (i.e., ICH Q3A, ICH Q3C, ICH Q3D, ICH Q6A, ICH M7, ICH S9, etc.) for test items such as identification (should be specific), assay, purity, particle size, crystal form, microbial limit, bacterial endotoxin, etc.
  2. 2. If HPLC retention time is used for identification, two separate HPLC analytical methods according to different chromatographic principles should be used since single HPLC method is not fulfilled the specification requirement.
  3. 3. Purity test should be established by evaluating potential impurities such as organic impurities, enantiomeric impurities, potential genotoxic substances, residual solvents, elemental impurities, water content, etc.

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