BRIEFING
Levothyroxine Sodium for Injection. 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 proposed Assay was validated using the Zorbax SB-CN brand of column with L10 packing. The typical retention time for levothyroxine is about 3.3 min.
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The liquid chromatographic procedure in the Organic Impurities test was validated using the Xterra RP18 column with L1 packing. The typical retention time for levothyroxine is about 17 min.
(SM3: S. Parepalli)
Case ID—SUB-1761