USP Monographs: Neomycin and Polymyxin B Sulfates and Bacitracin Ointment

Neomycin and Polymyxin B Sulfates and Bacitracin Ointment

» Neomycin and Polymyxin B Sulfates and Bacitracin Ointment contains the equivalent of not less than 90.0 percent and not more than 130.0 percent of the labeled amounts of neomycin, polymyxin B, and bacitracin. It may contain a suitable local anesthetic.

Packaging and storage— Preserve in tight, light-resistant containers, preferably at controlled room temperature.

USP Reference standards

— USP Bacitracin Zinc RS. USP Neomycin Sulfate RS. USP Polymyxin B Sulfate RS.

Thin-layer chromatographic identification test

201BNP

: meets the requirements.

Minimum fill

755

: meets the requirements.

Water, Method I

921

: not more than 0.5%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.

Residual solvents

467

: meets the requirements.

(Official January 1, 2007)

Assay for neomycin and Assay for polymyxin B— Proceed with Ointment as directed in the Assay for neomycin and in the Assay for polymyxin B under Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment.

Assay for bacitracin— Proceed with Ointment as directed in the Assay under Bacitracin Ointment.

Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 1503

Pharmacopeial Forum : Volume No. 28(4) Page 1160

Phone Number : 1-301-816-8223


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