Tetracycline Hydrochloride Ophthalmic Ointment
» Tetracycline Hydrochloride Ophthalmic Ointment contains not less than 90.0 percent and not more than 125.0 percent of the labeled amount of C22H24N2O8·HCl.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
Sterility 71: meets the requirements.
Minimum fill 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.
Metal particles— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments 751.
Assay— Proceed with Ophthalmic Ointment as directed in the Assay under Tetracycline Hydrochloride Ointment.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Ahalya Wise, M.S.
(MDANT05) Monograph Development-Antibiotics
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3698