USP Monographs: Neomycin Sulfate and Methylprednisolone Acetate Cream

Neomycin Sulfate and Methylprednisolone Acetate Cream

» Neomycin Sulfate and Methylprednisolone Acetate Cream contains the equivalent of not less than 90.0 percent and not more than 135.0 percent of the labeled amount of neomycin, and not less than 90.0 percent and not more than 110.0 percent of the labeled amount of methylprednisolone acetate (C24H32O6).

Packaging and storage— Preserve in collapsible tubes or in tight containers, protected from light.

USP Reference standards

— USP Methylprednisolone Acetate RS. USP Neomycin Sulfate RS.

Identification—

A: It meets the requirements for neomycin under Thin-Layer Chromatographic Identification Test

201BNP

B: In the thin-layer chromatogram prepared as directed in the Assay for methylprednisolone acetate, the RF value of the principal spot obtained from the Assay preparation corresponds to that obtained from the Standard preparation, prepared as directed in the Assay for methylprednisolone acetate.

Minimum fill

755

: meets the requirements.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay for neomycin— Proceed with Cream as directed in the Assay under Neomycin Sulfate Ointment.

Assay for methylprednisolone acetate— Proceed with Cream as directed in the Assay under Methylprednisolone Acetate Cream.

Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 1501

Pharmacopeial Forum : Volume No. 28(4) Page 1158

Phone Number : 1-301-816-8223


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