Topical Light Mineral Oil

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Topical Light Mineral oil is Light Mineral Oil that has been suitably packaged.

2 IDENTIFICATION

Change to read:

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197E _{(CN 1-MAY-2020)}

B. It meets the requirements in Specific Tests for Viscosity-Capillary Methods (911).

3 SPECIFIC TESTS

SPECIFIC GRAVITY (841): 0.818-0.880

VISCOSITY-CAPILLARY METHODS (911): 3.0-34.4 mm² s¹ for kinematic viscosity, measured with a capillary viscometer at 40 ± 0.1°

3.1 ACIDITY

Sample: 10 mL

Analysis: Add 20 mL of boiling water to the Sample, and shake vigorously for about 1 min. Allow to cool, and draw off the separated water. To 10 mL of the filtered aqueous layer add 0.1 mL of phenolphthalein TS.

Acceptance criteria: The solution does not produce a pink color. NMT 1.0 mL of 0.01 N sodium hydroxide is required to produce a pink color.

3.2 SOLID PARAFFIN

Sample: Topical Light Mineral Oil that has been dried previously in a beaker at 105° for 2 h and cooled to room temperature in a desiccator over silica gel

Analysis: Fill a tall, cylindrical, standard oil-sample bottle of colorless glass of 120-mL capacity with the Sample. Insert the stopper, and immerse the bottle in a mixture of ice and water for 4 h.

Acceptance criteria: The Sample solution is sufficiently clear that a black line 0.5 mm in width, on a white background, held vertically behind the bottle, is clearly visible.

4 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight, light-resistant containers. No storage requirements specified.

LABELING: Label it to indicate the name and quantity of any substance added as a stabilizer, and label packages intended for direct use by the public to indicate that it is not intended for internal use.

USP REFERENCE STANDARDS (11)

USP Mineral Oil RS