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OPHTHALMIC OINTMENTS
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
51).
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 51 and Antimicrobial Agents—Content 341). Sterilization processes are employed for the finished ointment or for all ingredients, if the ointment is manufactured under rigidly aseptic conditions, even though such substances are used (see also Parenteral and Topical Preparations in the section Added Substances, under General Notices, and Sterilization and Sterility Assurance of Compendial Articles 1211). Ophthalmic ointments that are packaged in single-use containers are not required to contain antibacterial agents; however, they meet the requirements for Sterility Tests 71.
51 and Antimicrobial Agents—Content 341). Sterilization processes are employed for the finished ointment or for all ingredients, if the ointment is manufactured under rigidly aseptic conditions, even though such substances are used (see also Parenteral and Topical Preparations in the section Added Substances, under General Notices, and Sterilization and Sterility Assurance of Compendial Articles 1211). Ophthalmic ointments that are packaged in single-use containers are not required to contain antibacterial agents; however, they meet the requirements for Sterility Tests 71.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
for 8 hours. No significant leakage occurs during or at the completion of the test (disregard traces of ointment presumed to originate externally from within the crimp of the tube or from the thread of the cap). If leakage is observed from one, but not more than one, of the tubes, repeat the test with 20 additional tubes of the Ointment. The requirement is met if no leakage is observed from the first 10 tubes tested, or if leakage is observed from not more than one of 30 tubes tested.
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| Topic/Question | Contact | Expert Committee |
| General Chapter | Desmond G. Hunt, Ph.D.
Scientist 1-301-816-8341 |
(GC05) General Chapters 05 |
USP32–NF27 Page 302