As for those active substances described in official pharmacopoeia monograph,stress testing is mandatory or not ?
according to CPMP/QWP/122/02,rev corr:
If there are named under "purity test" and/or "section on impurities", and the active substances completely meets the requirements of Pharmacopoeia, then no stress testing is needed.
therefore, I think, for those active substances with purity test or impurities itmes described in pharmocopoeia, in my idea, it's unnecessary to conduct such study.right or not? But why so many customers ask for those data? thanks in advance.
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original text is attached below:
stability testing of existing active substances//2.1.2 Stress testing
For an active substance the following approacehs may be used:
a) When an active substance is described in an official pharmacopoeia monograph and fully meets its requirements no dat are required on the degradaiton products if they are named under the headings "purity test" and/or "section on impurities".//