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This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously reg...
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In the fast-paced world of pharmaceutical manufacturing, efficiency is the cornerstone of success. For pharmaceutical companies ...
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When selecting packaging, manufacturers should prioritize material quality, sealing performance, and the use of desiccants to en...
ICH Q1 EWG Stability Testing of Drug Substances and Drug Products
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