Is it necessary to validate both assay and related
substances for usp official methods for products.
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Answer Posted / venugopal reddy
Based on the USP 1225 generachapter,
Analytical methods described in USP–NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposals for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity.
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