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.

Identification—

Specific gravity 841: between 0.818 and 0.880.

Viscosity 911— Perform the test at 40.0 ± 0.1 using a suitable capillary viscometer: the kinematic viscosity is between 3.0 and 34.4 mm2·s1.

Acidity— Add 20 mL of boiling water to 10 mL of Topical Light Mineral Oil, and shake vigorously for about 1 minute. Allow to cool, and draw off the separated water. To 10 mL of the filtrated aqueous layer add 0.1 mL of phenolphthalein TS: the solution does not produce a pink color. Not more than 1.0 mL of 0.01 N sodium hydroxide is required to change the color to pink.

Solid paraffin— Fill a tall, cylindrical, standard oil-sample bottle of colorless glass of about 120-mL capacity with Topical Light Mineral Oil that has been dried previously in a beaker at 105 for 2 hours and cooled to room temperature in a desiccator over silica gel. Insert the stopper, and immerse the bottle in a mixture of ice and water for 4 hours: the test specimen is sufficiently clear that a black line 0.5 mm in width, on a white background, held vertically behind the bottle, is clearly visible.

Topic/Question	Contact	Expert Committee
Monograph	Hong Wang, Ph.D. Scientist 1-301-816-8351	(EM205) Excipient Monographs 2
Reference Standards	Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org

USP32–NF27 Page 2985