![]() ![]() Added Substances— Suitable substances may be added to ophthalmic ointments to increase stability or usefulness, unless proscribed in the individual monograph, provided they are harmless in the amounts administered and do not interfere with the therapeutic efficacy or with the responses to the specified assays and tests. No coloring agent may be added, solely for the purpose of coloring the finished preparation, to an article intended for ophthalmic use (see also Added Substances under General Notices and under Antimicrobial Effectiveness Testing ![]() ![]() A suitable substance or mixture of substances to prevent the growth of microorganisms must be added to ophthalmic ointments that are packaged in multiple-use containers, regardless of the method of sterilization employed, unless otherwise directed in the individual monograph, or unless the formula itself is bacteriostatic. Such substances are used in concentrations that will prevent the growth of or kill microorganisms in the ophthalmic ointments (see also Antimicrobial Effectiveness Testing
![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() Containers— Containers, including the closures, for ophthalmic ointments do not interact physically or chemically with the preparation in any manner to alter the strength, quality, or purity beyond the official requirements under the ordinary or customary conditions of handling, shipment, storage, sale, and use. Leakage— Select 10 tubes of the Ointment, with seals applied when specified. Thoroughly clean and dry the exterior surfaces of each tube with an absorbent cloth. Place the tubes in a horizontal position on a sheet of absorbent blotting paper in an oven maintained at a temperature of 60 ± 3 ![]() Auxiliary Information— Please check for your question in the FAQs before contacting USP.
USP32–NF27 Page 302
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