(Ph. Eur. 11.6 update)
Action and use
Glucocorticoid.
DEFINITION
Betamethasone Valerate Scalp Application is a cutaneous solution. It contains Betamethasone Valerate in a suitable liquid basis.
The application complies with the requirements stated under Liquids for Cutaneous Application and with the following
requirements.
Content of betamethasone, C22H29FO5
90.0 to 115.0% of the stated amount.
IDENTIFICATION
A. Complies with test A for Identification described under Betamethasone Valerate Lotion, preparing solution (1) by diluting a suitable volume of the application with absolute ethanol to give a solution containing the equivalent of 0.04% w/v of betamethasone.
B. In the Assay, the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to betamethasone valerate in the chromatogram obtained with solution (1).
ASSAY
Carry out the Assay described under Betamethasone Valerate Lotion, preparing solutions (2) and (3) in the following manner. For solution (2) dilute a quantity of the application containing the equivalent of 3 mg of betamethasone to 25 mL
with ethanol (65%). For solution (3) add 5 mL of a 0.11% w/v solution of the internal standard to a quantity of the application containing the equivalent of 3 mg of betamethasone and dilute to 25 mL with ethanol (65%).
STORAGE
Betamethasone Valerate Scalp Application should be protected from light.
LABELLING
The quantity of active ingredient is stated in terms of the equivalent amount of betamethasone.
The label indicates the pharmaceutical form as ‘cutaneous solution’.
