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Impurity Control Strategy

The document provides guidelines on the reporting, identification, and qualification of impurities in new drug substances and products, including classifications of organic, inorganic impurities, and residual solvents. It outlines the rationale for controlling these impurities, analytical procedures for their detection, and the necessary specifications for reporting results. Additionally, it discusses the management of degradation products arising from chemical changes during manufacturing and storage.

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shiv7895311799
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27 views41 pages

Impurity Control Strategy

The document provides guidelines on the reporting, identification, and qualification of impurities in new drug substances and products, including classifications of organic, inorganic impurities, and residual solvents. It outlines the rationale for controlling these impurities, analytical procedures for their detection, and the necessary specifications for reporting results. Additionally, it discusses the management of degradation products arising from chemical changes during manufacturing and storage.

Uploaded by

shiv7895311799
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF or read online on Scribd

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