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 60days 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 á11ñ— USP Bacitracin Zinc RS.USP Endotoxin RS.

Thin-layer chromatographic identification test á201BNPñ: meets the requirements.

pHá791ñ: between 5.5and 7.5,in a solution containing 10,000Bacitracin Units per mL.

Loss on drying á731ñ— Dry about 100mg in a capillary-stoppered bottle in vacuum at a pressure not exceeding 5mm of mercury at 60for 3hours:it loses not more than 5.0%of its weight.

Other requirements— Where the label states that Bacitracin is sterile,it meets the requirements for Sterility Tests á71ñand,where intended for injectable dosage forms,for Bacterial endotoxinsunder 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 endotoxinsunder Bacitracin for Injection.

Assay— Proceed with Bacitracin as directed under Antibiotics—Microbial Assays á81ñ.

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 214

Phone Number:1-301-816-8335