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Selenium Sulfide Lotion
(Current title—not to change until July 1, 2007)
Monograph title change—to become official July 1, 2007
See Selenium Sulfide Topical Suspension
» Selenium Sulfide Lotion is an aqueous, stabilized suspension of Selenium Sulfide. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of SeS2. It contains suitable buffering and dispersing agents.
NOTE—Where labeled for use as a shampoo, it contains a detergent. Where labeled for other uses, it may contain a detergent.
Packaging and storage— Preserve in tight containers.
Identification— Digest about 2 g with 5 mL of nitric acid over gentle heat for 1 hour, dilute with water to about 50 mL, and filter: the solution responds to Identification test A under Selenium Sulfide, when tested as directed, beginning with “to 10 mL of the filtrate add 5 mL of water.”
pH 791: between 2.0 and 6.0.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Place a portion of well-mixed Lotion, equivalent to about 100 mg of selenium sulfide and accurately weighed, in a suitable flask. Cautiously digest with 25 mL of fuming nitric acid over gentle heat for 2 hours, and proceed as directed in the Assay under Selenium Sulfide, beginning with “Cool, transfer the solution to a 250-mL volumetric flask.” Each mL of 0.05 N sodium thiosulfate is equivalent to 1.789 mg of SeS2. Where the Lotion is labeled in terms of percentage (w/v) or of the amount of SeS2 in a given volume of Lotion, determine the density of the Lotion as follows: Using a tared, 100-mL volumetric flask, weigh 100 mL of Lotion that previously has been shaken to ensure homogeneity, allowed to stand until the entrapped air rises, and finally inverted carefully just prior to transfer to the volumetric flask. From the observed weight of 100 mL of the Lotion, calculate the quantity of SeS2 in each 100 mL.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 1958
Pharmacopeial Forum : Volume No. 30(2) Page 537
Phone Number : 1-301-816-8320