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.
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.
Assay for methylprednisolone acetate
Proceed with Cream as directed in the Assay under Methylprednisolone Acetate Cream.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 3055
Pharmacopeial Forum: Volume No. 28(4) Page 1158
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