Tag: ICH-Q3

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Defining Specification Limits for Unknown, Known and Total Impurities in New Drug Products with HPLC

Defining Specification Limits for Impurities in New Drug Products

Learn how pharmaceutical manufacturers define specification limits for known, unknown, and total impurities in new drug products, ensuring safety and...
Person working in QC Lab - LC

Impurities in Pharmaceuticals: Types, Regulations and Strategies

Discover the essential information about impurities in pharmaceuticals, their types, and how they impact drug quality. Learn about regulatory requirements,...

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