Bland Lubricating Ophthalmic Ointment
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
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.
2 SPECIFIC TESTS
2.1 APPEARANCE
Analysis: Transfer a portion of it to a suitable test tube, and examine the sample in front of a light source.
Acceptance criteria: The sample appears translucent.
STERILITY TESTS (71): Meets the requirements
2.2 ACIDITY OR ALKALINITY
Sample solution: Transfer 20.0 g of Ophthalmic Ointment to a 400-mL beaker. Add 100 mL of a mixture of neutralized alcohol and water (1 in 2), agitate thoroughly, and gradually heat to boiling. Boil for 10 min.
Analysis: To the Sample solution 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).
Acceptance criteria: NMT 0.40 mL of 0.1 N hydrochloric acid VS or 0.1 N sodium hydroxide VS is required to produce the color change.
2.3 COLOR
Analysis: Examine the extruded Ophthalmic Ointment for color.
Acceptance criteria: Colorless to light yellow
OTHER REQUIREMENTS: It meets the requirements for Particulate and Foreign Matter in Ophthalmic Products-Quality Tests (771), Drug Product Quality, Universal Tests, Particulate and Foreign Matter.
3 ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in suitable collapsible ophthalmic ointment tubes.
