Tag: Impurities

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Gas Chromatography for testing residual solvents in GMP

Residual Solvents in GMP: Classes, Guidelines and Testing

Explore the classes and regulatory guidelines used in Residual Solvents testing in GMP....
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,...
Topical Ophthalmic Drug Products

FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products

Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products. Stay informed on key considerations for...

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