Chlortetracycline Hydrochloride Ophthalmic Ointment
» Chlortetracycline Hydrochloride Ophthalmic Ointment contains not less than 90.0 percent and not more than 125.0 percent of the labeled amount of C22H23ClN2O8·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 as directed under AntibioticsMicrobial Assays 81, using an accurately weighed quantity of Ophthalmic Ointment, equivalent to about 10 mg of chlortetracycline hydrochloride, shaken in a separator with about 50 mL of ether, and extracted with four 20-mL portions of 0.01 N hydrochloric acid. Combine the aqueous extracts in a 100-mL volumetric flask, dilute with 0.01 N hydrochloric acid to volume, and mix. Dilute this stock solution quantitatively and stepwise with water to obtain a Test Dilution having a concentration assumed to be equal to the median dose level of the Standard.
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USP32NF27 Page 1919