Tetracaine Ophthalmic Ointment
» Tetracaine Ophthalmic Ointment is a sterile ointment containing not less than 0.45 percent and not more than 0.55 percent of C15H24N2O2 in White Petrolatum.
Packaging and storage— Preserve in collapsible ophthalmic ointment tubes.
A: The solution employed for measurement of absorbance in the Assay exhibits a maximum at 310 ± 2 nm.
B: Dissolve 5 g in 50 mL of ether, extract the ether solution with 5 mL of 3 N hydrochloric acid, and filter the extract. To the extract add 2 mL of potassium thiocyanate solution (1 in 2): a crystalline precipitate is formed, and when recrystallized from water and dried at 80 for 2 hours, it melts between 130 and 132 (see Melting Range or Temperature 741).
Sterility 71: meets the requirements .
Minimum fill 755: meets the requirements.
Metal particles— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments 751.
Standard preparation— Prepare as directed in the Assay under Tetracaine Ointment.
Assay preparation— Using an accurately weighed portion of Ophthalmic Ointment, prepare as directed in the Assay under Tetracaine Ointment.
Procedure— Proceed as directed for Procedure in the Assay under Tetracaine Ointment.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3689