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What is API Potency and Assay Calculation Guide about?

This document discusses how to calculate the potency or assay of an active pharmaceutical ingredient (API). It covers adjusting for moisture content, salt removal or factor adjustment, and calculating the percentage of API in a formulation. The key steps are compensating for moisture content using a factor, removing salt using molecular weight ratios, and determining API percentage based on amounts used.

Author

Dharmesh Patel

Language

EN