Soluble Bacitracin Methylenedisalicylate
DEFINITION
Soluble Bacitracin Methylenedisalicylate is a mixture of Bacitracin Methylenedisalicylate and Sodium Bicarbonate. It has a potency of NLT 8 Bacitracin Units/mg, calculated on the dried basis.
ASSAY
• Antibiotics—Microbial Assays 
81
81
Diluent:
20 g/L of sodium bicarbonate
Sample stock solution:
Transfer a suitable amount of Soluble Bacitracin Methylenedisalicylate 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:
NLT 8 Bacitracin Units/mg on the dried basis
SPECIFIC TESTS
• pH 791:
8.0–9.5, in a 25 mg/mL solution
791:
8.0–9.5, in a 25 mg/mL solution
• Loss on Drying 731:
Dry 100 mg in a capillary-stoppered bottle in 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 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 well-closed containers.
• Labeling:
Label it to indicate that it is for veterinary use only.
• 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 1105