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Impurity profiling in pharmaceuticals

Impurity profiling in pharmaceuticals

Paperback

Medical Reference

ISBN10: 6208435757
ISBN13: 9786208435752
Publisher: LAP Lambert Academic Publishing
Published: Apr 24 2025
Pages: 52
Weight: 0.18
Height: 0.12 Width: 6.00 Depth: 9.00
Language: English
Impurity profiling in pharmaceuticals refers to the process of identifying, characterizing, and quantifying any unwanted substances (impurities) present in a drug substance or drug product, which is crucial for ensuring safety and efficacy by monitoring and controlling their levels within acceptable regulatory limits; this involves using advanced analytical techniques to detect and analyze the structure of these impurities to assess potential toxicological risks.

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Jamdhade, Mansi

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Medical Reference