What could be the possible reasons to not achieve mass balance in assay and RS methods of a drug solution packed in LDPE ampules?

Upon stability, the assay reduces to 91 to 92% but the remaining 8 to 9% is not being compensated by impurities. Assay and RS, both methods have been developed using HPLC. To identify...

22 January 2019 2,674 4 View