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Is it necessary to validate both assay and related
substances for usp official methods for products.
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Answer Posted / gokul yeole (archpharmalabs)
Yes,For USP official method it mens compandial methods
should be validate, Partial validation required
like Robtness,rugdness,Precision, Linearity, Accuracy,
Specificity
Because of in our product we don`t know which system and
lab will use for analysis.
non compandial methods do all parameter which is mentioned
in ICH Q2 guidline.
| Is This Answer Correct ? | 3 Yes | 1 No |
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