Bland Lubricating Ophthalmic Ointment
» Bland Lubricating Ophthalmic Ointment is a sterile ointment of white petrolatum and mineral oil. It may contain Lanolin, Modified Lanolin, or Lanolin Alcohols. It may also contain a suitable antimicrobial preservative.
Packaging and storage— Preserve in suitable collapsible ophthalmic ointment tubes.
Appearance— Transfer a portion of it to a suitable test tube, and examine the sample in front of a light source: the sample should appear translucent.
Color— Examine the extruded ointment for color: it is colorless to light yellow.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
Homogeneity— Transfer about 250 mg of it to a clean microscope slide and examine for separation: no oily or watery substances should be visibly separated from the ointment. Place a cover slip on the ointment and flatten until light readily passes through the sample. Examine for agglomeration: no solid particles are visible.
Acidity or alkalinity— Transfer 20.0 g of it to a 400-mL beaker, add 100 mL of a 1 in 2 mixture of neutralized alcohol and water, agitate thoroughly, and gradually heat to boiling. Boil for 10 minutes. Add 1 mL of phenolphthalein TS and rapidly titrate, with vigorous agitation, with either 0.1 N sodium hydroxide VS (from a colorless alcohol-water layer to a sharp pink endpoint) or 0.1 N hydrochloric acid VS (from a pink alcohol-water layer to a colorless endpoint): not more than 0.40 mL of 0.1 N titrant is required.
Metal particles— It meets the requirements of the test for Metal Particles in Ophthalmic Ointments 751.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Feiwen Mao, M.S.
(MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3143