BRIEFING
Eslicarbazepine Acetate Tablets. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure in the Assay was validated using the Eclipse XBD C8 brand of column with L7 packing. The typical retention time for eslicarbazepine acetate is about 4.2 min.
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The liquid chromatographic procedure in the Dissolution test was validated using the Inertsil ODS-3V brand of column with L1 packing. The typical retention time for eslicarbazepine acetate is about 2.4 min.
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The liquid chromatographic procedure in the Organic Impurities test was validated using the Zorbax RX-C8 brand of column with L7 packing. The typical retention time for eslicarbazepine acetate is about 16 min.
(SM4: Q. Huynh)
Case ID—SUB-496, SUB-2585