Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment
» Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment is a sterile ointment containing Oxytetracycline Hydrochloride and Polymyxin B Sulfate. It contains the equivalent of not less than 90.0 percent and not more than 120.0 percent of the labeled amount of oxytetracycline, and not less than 90.0 percent and not more than 125.0 percent of the labeled amount of polymyxin B.
Packaging and storage—
Preserve in collapsible ophthalmic ointment tubes.
Sterility 
71
:
meets the requirements.
71:
meets the requirements.
Minimum fill 755:
meets the requirements.
755:
meets the requirements.
Water, Method I 921:
not more than 1.0%, 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 1.0%, 20 mL of a mixture of toluene and methanol (7:3) being used in place of methanol in the titration vessel.
Metal particles—
It meets the requirements of the test for Metal Particles in Ophthalmic Ointments 751.
751.
Assay for oxytetracycline—
Proceed with Ophthalmic Ointment as directed in the Assay for oxytetracycline under Oxytetracycline Hydrochloride and Hydrocortisone Ointment.
Assay for polymyxin B—
Proceed with Ophthalmic Ointment as directed in the Assay for polymyxin B under Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ointment.
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 |
|
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Senior Scientist 1-301-816-8339 |
(MSA05) Microbiology and Sterility Assurance |
USP32–NF27 Page 3184