Bacitracin Methylenedisalicylate Soluble Powder
DEFINITION
Bacitracin Methylenedisalicylate Soluble Powder contains NLT 90.0% and NMT 120.0% of the labeled amount of bacitracin.
ASSAY
• Antibiotics—Microbial Assays 
81
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 No. 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.
81.
Acceptance criteria:
90.0%—120.0%
SPECIFIC TESTS
• pH 791:
8.0–9.5 in a 50 mg/mL solution
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.
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.
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
11
USP Bacitracin Zinc RS
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Morgan Puderbaugh, B.S.
Associate Scientific Liaison 1-301-998-6833 |
(SM32010) Monographs - Small Molecules 3 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2297
Pharmacopeial Forum: Volume No. 35(5) Page 1106