U.S. PHARMACOPEIA

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Halcinonide Topical Solution
» Halcinonide Topical Solution is Halcinonide in a suitable aqueous vehicle. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C24H32ClFO5.
Packaging and storage— Preserve in well-closed containers.
Identification— It responds to the Identification test under Halcinonide Cream.
Microbial limits 61 It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Mobile phase— Mix approximately equal volumes of acetonitrile and water, adjusting the ratio of solvents as necessary to achieve acceptable chromatography.
Internal standard solution— Transfer 15 mg of Progesterone to a 50-mL volumetric flask. Dissolve in Mobile phase, dilute with Mobile phase to volume, and mix.
Standard preparation— Transfer about 20 mg of USP Halcinonide RS, accurately weighed, to a 100-mL volumetric flask, dissolve in Mobile phase, dilute with Mobile phase to volume, and mix. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, add 2.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.
Assay preparation— Transfer an accurately measured quantity of Topical Solution, equivalent to about 1 mg of halcinonide, to a 50-mL volumetric flask, add 2.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.
Chromatographic system and Procedure Proceed as directed in the Assay under Halcinonide Cream. Calculate the quantity, in mg, of C24H32ClFO5 in the portion of Topical Solution taken by the formula:
50C(RU / RS),
in which the terms are as defined therein.
Auxiliary Information— Staff Liaison : Clydewyn M. Anthony, Ph.D., Scientist
Expert Committee : (MDCCA05) Monograph Development-Cough Cold and Analgesics
USP29–NF24 Page 1042
Phone Number : 1-301-816-8139