á771ñOPHTHALMIC 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 Substancesunder General Noticesand under Antimicrobial Effectiveness Testing á51ñ).
Asuitable 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 á51ñand Antimicrobial Agents—Content á341ñ).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 Preparationsin the section Added Substances,under General Notices,and Sterilization and Sterility Assurance of Compendial Articles á1211ñ).Ophthalmic ointments that are packaged in single-use containers are not required to contain antibacterial agents;however,they meet the requirements for Sterility Tests á71ñ.
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 10tubes 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 8hours.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 20additional tubes of the Ointment.The requirement is met if no leakage is observed from the first 10tubes tested,or if leakage is observed from not more than one of 30tubes tested.