Neomycin Sulfate and Bacitracin Ointment
»Neomycin Sulfate and Bacitracin Ointment contains the equivalent of not less than 90.0percent and not more than 130.0percent of the labeled amounts of neomycin and bacitracin.
Packaging and storage— Preserve in tight,light-resistant containers,preferably at controlled room temperature.
Thin-layer chromatographic identification test á201BNPñ: meets the requirements.
Minimum fill á755ñ: meets the requirements.
Water,Method Iá921ñ: not more than 0.5%,20mLof a mixture of toluene and methanol (7:3)being used in place of methanol in the titration vessel.
Assay for neomycin— Proceed with Ointment as directed in the Assayunder Neomycin Sulfate Ointment.
Assay for bacitracin— Proceed with Ointment as directed in the Assayunder Bacitracin Ointment
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1344
Pharmacopeial Forum:Volume No.28(4)Page 1153
Phone Number:1-301-816-8335