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.
Microbial enumeration tests 61 and Tests for specified microorganisms 62
It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.
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
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Chromatographic Column
USP32NF27 Page 2547
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.
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