Neomycin Sulfate and Hydrocortisone Acetate Lotion
» Neomycin Sulfate and Hydrocortisone Acetate Lotion contains the equivalent of not less than 90.0 percent and not more than 130.0 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.
USP Reference standards 11
USP Neomycin Sulfate RS
A: It meets the requirements for neomycin under Thin-Layer Chromatographic Identification Test 201BNP.
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 755: meets the requirements.
Assay for neomycin Proceed as directed for neomycin under AntibioticsMicrobial Assays 81, blending an accurately measured volume of Lotion for 3 to 5 minutes in a high-speed glass blender jar containing an accurately measured volume of Buffer No. 3. Dilute an accurately measured volume of the solution so obtained quantitatively and stepwise with Buffer No. 3 to obtain a Test Dilution having a concentration of neomycin assumed to be equal to the median dose level of the Standard.
Assay for hydrocortisone acetate Proceed with Lotion as directed in the Assay under Hydrocortisone Acetate Lotion.
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USP35NF30 Page 4016Pharmacopeial Forum: Volume No. 30(2) Page 518