Bacitracin Methylenedisalicylate Soluble Powder
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Bacitracin Methylenedisalicylate Soluble Powder contains NLT 90.0% and NMT 120.0% of the labeled amount of bacitracin.
2 ASSAY
ANTIBIOTICS-MICROBIAL, ASSAYS (81)
Diluent: 20 g/L of sodium bicarbonate
Sample stock solution: Transfer a suitable amount of Bacitracin Methylenedisalicylate Soluble Powder to a high-speed glass blender jar, add 99.0 mL of Diluent and 1.0 mL of Polysorbate 80, and blend for 3 min.
Test dilution: To a suitable aliquot of the Sample stock solution, add a suitable volume of 0.01 N hydrochloric acid and dilute with Buffer B. 1 to obtain a concentration of bacitracin assumed to be equal to the median dose level of the Standard. [NOTE-The amount of hydrochloric acid in the Test dilution should be the same as that in the median dose level of the Standard.]
Analysis: Proceed as directed for Bacitracin in Antibiotics-Microbial Assays (81)
Acceptance criteria: 90.0%-120.0%
3 SPECIFIC TESTS
PH (791): 8.0-9.5 in a 50 mg/mL solution
LOSS ON DRYING (731): Dry 100 mg in a capillary-stoppered bottle in a vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 h: it loses NMT 8.5% of its weight.
4 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight containers.
LABELING: Label it to indicate that it is for veterinary use only. Label it to state the content of bacitracin in terms of grams per pound, each gram of bacitracin being equivalent to 42,000 Bacitracin Units.
USP REFERENCE STANDARDS (11)
USP Bacitracin Zinc RS
