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Neomycin Sulfate and Hydrocortisone Acetate Cream
» Neomycin Sulfate and Hydrocortisone 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 hydrocortisone acetate (C23H32O6).
Packaging and storage
Preserve in well-closed containers.
Identification
A:
It meets the requirements for neomycin under Thin-Layer Chromatographic Identification Test
B:
The retention time of the major peak for hydrocortisone acetate in the chromatogram of the Assay preparation, corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay for hydrocortisone acetate.
Minimum fill
Assay for neomycin
Proceed with Cream as directed in the Assay under Neomycin Sulfate Ointment.
Assay for hydrocortisone acetate
Proceed with Cream as directed in the Assay under Hydrocortisone Acetate Lotion.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4016
Pharmacopeial Forum: Volume No. 30(2) Page 517
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