How does one justify the suitability of a primary reference standard if the primary reference standard is not purchased from a pharmacopoeial or equivalent sources?

刊登日期:2020-07-22  |  點閱次數 : 863 次 

In order to justify the suitability of the non-pharmacopoeial or equivalent primary reference standard, several structural elucidation methods should be used to confirm the molecular structure of the reference standard. In addition, validated analytical methods should be used to quantify the quantities of impurities such as organic impurities, inorganic impurities, water and residual solvents in the primary reference standard. The assigned content of the reference standard should then be calculated using the measured quantities of impurities and confirmed using other orthogonal quantitative methods (such as: QNMR, DSC, etc.) (Please refer to Ph. Eur. reference standard.)



上一筆 If a drug substance may contain different numbers of solvated water (ex: anhydrou
下一筆 When submitting a DMF or API registration application, if the specification of th