During Levothyroxine sodium tablet fd study analysis mass balance problem was observed?

04 July 2020 0 9K Report

During FD study assay of sample found 85 percent but degradation product was found only about 3%(Controlled sample assay is 100%). we have checked impurities RRF, we have checked degraded sample with extended run with maximum solvent & also checked by changing diluent. but still facing mass balance issue.

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