hplc assay limit 98.0 to 105 why

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hplc assay limit 98.0 to 105 why..

Answer / chetan

For release of most of the drug product its 98 to 102%.
for stability it is 95 to 105%.

Limit set according to specification and previous stability data of drug substance.

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hplc assay limit 98.0 to 105 why..

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