Oxytetracycline Hydrochloride and Polymyxin B Sulfate Topical Powder
» Oxytetracycline Hydrochloride and Polymyxin B Sulfate Topical Powder contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amounts of oxytetracycline (C22H24N2O9) and polymyxin B in a suitable, fine powder base.
Packaging and storage Preserve in well-closed containers.
USP Reference standards 11
USP Polymyxin B Sulfate RS
Minimum fill 755: meets the requirements.
Loss on drying 731 Dry about 100 mg, accurately weighed, in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 2.0% of its weight.
Assay for oxytetracycline Transfer a suitable, accurately weighed quantity of Topical Powder to a glass blender jar containing a sufficient, accurately measured volume of 0.1 N hydrochloric acid to yield a stock solution containing not less than 150 µg of oxytetracycline per mL, and blend at high speed for 3 to 5 minutes. Proceed as directed for oxytetracycline under AntibioticsMicrobial Assays 81, using an accurately measured volume of this solution diluted quantitatively and stepwise with water to obtain a Test Dilution having a concentration of oxytetracycline assumed to be equal to the median dose level of the Standard.
Assay for polymyxin B Transfer an accurately weighed quantity of Topical Powder, equivalent to about 10,000 USP Polymyxin B Units, to a 50-mL centrifuge tube, add 15 mL of acetone and 0.05 mL of hydrochloric acid, and stir. Add 20 mL of acetone, and centrifuge for 10 minutes. Decant and discard the clear liquid. Add 15 mL of acetone and 0.05 mL of hydrochloric acid to the residue, stir, add 20 mL of acetone, and centrifuge for 10 minutes, decanting and discarding the clear liquid. [noteTake care not to discard any of the residue with the clear liquid. ] Add 5 mL of Buffer No. 6 to the residue, and mix. Transfer the mixture to a 100-mL volumetric flask with the aid of Buffer No. 6, dilute with the same solvent to volume, and mix. Proceed as directed for polymyxin B under AntibioticsMicrobial Assays 81, using an accurately measured volume of this stock solution diluted quantitatively with Buffer No. 6 to obtain a Test Dilution having a concentration of polymyxin B assumed to be equal to the median dose level of the Standard.
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USP35NF30 Page 4192