BRIEFING
Zinc Sulfate Injection. This proposal is based on the version of the monograph official as of May 1, 2018. It is proposed to revise the monograph with the following changes:
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Add Identification B, which is based on the retention time match as obtained in the Assay.
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Replace the current atomic absorption spectrophotometry procedure in the Assay with a validated liquid chromatographic procedure. The procedure was validated using a Dionex IonPac CG5A brand of column with L100 packing. The typical retention time for zinc is about 6 min.
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Add USP Reference Standards 〈11〉 to support the addition of USP Zinc Sulfate RS in the Assay.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
(SM3: R. Fales)
Case ID—SUB-1424