Witrynaimpurities being carried forward), unless it is consistently and convincingly demonstrated that the process is capable to purge the impurity from the final substance to a level which is below 30% of the appropriate concentration limit (preferably based on option 1 of table A.2.2 of the WitrynaOsimertinib Impurity 13-d6 Ref. 4Z-A-194027 Estimated delivery in United States, on Tuesday 3 Jan 2024 Active Pharmaceutical Ingredients (API) for research Deuterated …
EDQM Training Module 3: Impurity Control in the Ph. Eur.
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