Bacitracin for Injection

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Bacitracin for Injection has a potency of NLT 50 Bacitracin Units/mg. It contains NLT 90.0% and NMT 115.0% of the labeled amount of bacitracin.

2 IDENTIFICATION

A. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST (201BNP): Meets the requirements

3 ASSAY

PROCEDURE

(See Antibiotics-Microbial Assays (81).)

Sample solution 1: Nominally 100 Bacitracin Units/mL, prepared as follows, Constitute one container of Bacitracin for Injection as directed in the labeling. Using a suitable hypodermic needle and syringe, withdraw the contents of the container, and dilute with Buffer B.1 (see the chapter) to a suitable volume.

Sample solution 2 (where the label states the number of Bacitracin Units in a given volume of constituted solution): Nominally 100 Bacitracin Units/mL, prepared as follows. Constitute one container of Bacitracin for Injection as directed in the labeling. Dilute a suitable aliquot of the constituted solution with Buffer B.1 (see the chapter) to a suitable final volume.

Analysis

Samples: Sample solution 1 or Sample solution 2

Proceed as directed in the chapter. Add sufficient 0.01 N hydrochloric acid to the Sample solution so that the amount of hydrochloric acid in the Test Dilution is the same as in the median level of the standard. Dilute with Buffer B.1 to obtain a Test Dilution having a bacitracin concentration that is nominally equivalent to the median level of the standard.

Acceptance criteria: 90.0%-115.0%

4 PERFORMANCE TESTS

UNIFORMITY OF DOSAGE UNITS (905): Meets the requirements

5 IMPURITIES

RESIDUE ON IGNITION (281).

Analysis: Moisten the charred residue with 2 mL of nitric acid and 5 drops of sulfuric acid.

Acceptance criteria: NMT 3.0%

6 SPECIFIC TESTS

CONSTITUTED SOLUTION: At the time of use, it meets the requirements in Injections and Implanted Drug Products (1), Specific Tests, Completeness and clarity of solutions

PH (791)

Sample solution: A solution containing 10,000 Bacitracin Units/mL

Acceptance criteria: 5.5-7.5

LOSS ON DRYING (731)

Analysis: Dry 100 mg in a capillary-stoppered bottle under vacuum at a pressure of NMT 5 mm of mercury at 60° for 3 h.

Acceptance criteria: NMT 5.0%

STERILITY TESTS (71); It meets the requirements when tested as directed in Test for Sterility of the Product to Be Examined. Membrane Filtration.

BACTERIAL ENDOTOXINS TEST (85): It contains NMT 0.01 USP Endotoxin Unit/Bacitracin Unit.

OTHER REQUIREMENTS: Meets the requirements in Injections and Implanted Drug Products (1)

7 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve as described in Packaging and Storage Requirements (659). Injection Packaging. Packaging for constitution, and store in a cool place.

USP REFERENCE STANDARDS (11)

USP Bacitracin Zinc RS