Bacitracin Ointment
» Bacitracin Ointment is Bacitracin in an anhydrous ointment base. It contains not less than 90.0 percent and not more than 140.0 percent of the labeled amount of bacitracin. It may contain a suitable anesthetic.
Packaging and storage—
Preserve in well-closed containers containing not more than 60 g, unless labeled solely for hospital use, preferably at controlled room temperature.
Thin-layer chromatographic identification test 
201BNP
:
meets the requirements.
201BNP:
meets the requirements.
Minimum fill 755:
meets the requirements.
755:
meets the requirements.
Water, Method I 921:
not more than 0.5%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
921:
not more than 0.5%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
Assay—
Proceed as directed under Antibiotics—Microbial Assays 81, using an accurately weighed portion of Ointment shaken with about 50 mL of ether in a separator, and extracted with four 20-mL portions of Buffer No. 1. Combine the buffer extracts, and dilute with Buffer No. 1 to an appropriate volume to obtain a stock solution. Add sufficient 0.01 N hydrochloric acid to an accurately measured portion of the stock solution so that the amount of hydrochloric acid in the Test Dilution will be the same as in the median dose level of the Standard, and quantitatively dilute with Test Dilution having a bacitracin concentration assumed to be equal to the median dose level of the Standard.
81, using an accurately weighed portion of Ointment shaken with about 50 mL of ether in a separator, and extracted with four 20-mL portions of Buffer No. 1. Combine the buffer extracts, and dilute with Buffer No. 1 to an appropriate volume to obtain a stock solution. Add sufficient 0.01 N hydrochloric acid to an accurately measured portion of the stock solution so that the amount of hydrochloric acid in the Test Dilution will be the same as in the median dose level of the Standard, and quantitatively dilute with Test Dilution having a bacitracin concentration assumed to be equal to the median dose level of the Standard.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Ahalya Wise, M.S.
Scientist 1-301-816-8161 |
(MDANT05) Monograph Development-Antibiotics |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 1621
Pharmacopeial Forum: Volume No. 28(4) Page 1070