T/R potency <5% [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-09-09 19:42 (151 d 03:24 ago) – Posting: # 23287
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Hi Achievwin!

Just trying to be simple, lets assume a T/R ratio of 90-111.1%. Based on your spec, assay limit can be +/- 10%.
The assay of test for assumption is 95% and Ref is 105%. With such scenario, it can be assumed that your T/R ratio can be on lower side and vice versa.
But if assay of test is 98% and ref is 102% (difference is LT 5%), the 90% CI limit can have higher probability be tighter than the previous case.
The ageing impact can vary with drug product, and thus it should be considered on case by case basis.
The overages (for e.g. Vitamins) can also be a challenge in such scenario.
Meeting your target for exact assay can be challenging in manufacturing where loss is observed resulting in to lower assay.

Thank you Helmut for the point in Health Canada.

Regards,
Divyen

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