Crotamiton Lotion

Crotamiton Cutaneous Suspension

Crotamiton Lotion is a cutaneous suspension. It contains Crotamiton in a suitable vehicle.

The lotion complies with the requirements stated under Liquids for Cutaneous Application and with the following requirements.

93.0 to 107.0% of the stated amount.

A. To a quantity of the lotion containing 0.5 g of Crotamiton add 30 mL of 1m hydrochloric acid and shake to produce a uniform suspension. Extract with 100 mL of petroleum spirit (boiling range, 40° to 60°), wash the petroleum spirit layer with 10 mL of 1m hydrochloric acid, with two 10 mL quantities of 1m sodium hydroxide and then with 10 mL of a saturated solution of sodium chloride. Dry the organic layer over anhydrous sodium sulfate, filter and evaporate to an oily residue. The light absorption, Appendix II B, in the range 220 to 350 nm of a 0.003% w/v solution of the residue in cyclohexane exhibits a maximum only at 242 nm. The A(1%, 1 cm) at the maximum is about 315.

B. Carry out Identification test B described under Crotamiton Cream using the residue from test A above in the preparation of solution (1).

C. In the Assay, the principal peak in the chromatogram obtained with solution (2) has the same retention time as the principal peak in the chromatogram obtained with solution (3).

Complies with the test described under Crotamiton Cream.

Not more than 15% of the total content of E- and Z-isomers determined in the Assay.

Carry out the Assay described under Crotamiton Cream using a quantity of the lotion containing 0.1 g of Crotamiton.