Topical Light Mineral Oil
» Topical Light Mineral Oil is Light Mineral Oil that has been suitably packaged.
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.
B: It meets the requirements of the test for Viscosity.
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Hong Wang, Ph.D.
(EM205) Excipient Monographs 2
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 2985
Pharmacopeial Forum: Volume No. 33(5) Page 964