Bacitracin.
Bacitracin [1405-87-4].

Packaging and storage— Preserve in tight containers, and store in a cool place.

Labeling— Where it is packaged for prescription compounding, label it to indicate that it is not sterile and that the potency cannot be assured for longer than 60 days after opening, and to state the number of Bacitracin Units per milligram. Where it is intended for use in preparing injectable or other sterile dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable or other sterile dosage forms.

USP Reference standards 11— USP Bacitracin Zinc RS. USP Endotoxin RS.

Thin-layer chromatographic identification test 201BNP: meets the requirements.

pH 791: between 5.5 and 7.5, in a solution containing 10,000 Bacitracin Units per mL.

Loss on drying 731— Dry about 100 mg 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 5.0% of its weight.

Residual solvents 467: meets the requirements.

Other requirements— Where the label states that Bacitracin is sterile, it meets the requirements for Sterility Tests 71 and, where intended for injectable dosage forms, for Bacterial endotoxins under Bacitracin for Injection. Where the label states that Bacitracin must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Bacitracin for Injection.

Assay— Proceed with Bacitracin as directed under Antibiotics—Microbial Assays 81.

Expert Committee : (MDANT05) Monograph Development-Antibiotics

USP29–NF24 Page 233

Phone Number : 1-301-816-8223