l-Glutamic acid, N-(aminocarbonyl)-;
N-Carbamoyl-l-glutamic acid [1188-38-1]
BRIEFING
Carglumic Acid. Because there is no existing USP monograph for this drug substance, a new monograph based on validated test methods is proposed. Based on comments received, the proposals in PF 41(6) and PF 47(6) have been canceled and are being replaced with a new proposal.
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The liquid chromatographic procedure in the Assay and the test for Organic Impurities is based on the validation performed with the NUCLEODUR C18 Pyramid brand of column with L1 packing. The typical retention time for carglumic acid is about 4 min.
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The liquid chromatographic procedure in the test for Limit of d-Carglumic Acid is based on the validation performed with the Astec CHIROBIOTIC TAG brand of column with L63 packing. The typical retention time for d-carglumic acid is about 7 min.
Description and solubility information: White crystalline powder. Soluble in boiling water, slightly soluble in cold water, and practically insoluble in organic solvents.
(SM6: M. Fadadu)
Case ID—SUB-2218