Diltiazem Hydrochloride Injection

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BRIEFING

Diltiazem Hydrochloride Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.

The liquid chromatographic procedure in the Assay was validated using the InertSustain C18 brand of column with L1 packing. The typical retention time for diltiazem is about 9 min.
The liquid chromatographic procedure in the test for Organic Impurities was validated using the InertSustain C18 brand of column with L1 packing. The typical retention time for diltiazem is about 17 min.

(SM2: M. Fadadu)

Case ID—SUB-79

USP REFERENCE STANDARDS FOR PURCHASE

USP Desacetyl Diltiazem Hydrochloride RS
USP Diltiazem Hydrochloride RS

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