Halcinonide Topical Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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>> 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 C₂₄H₃₂CIFO₅.

1 Packaging and storage

Preserve in well-closed containers.

2 USP REFERENCE STANDARDS (11)

USP Halcinonide RS

3 Identification

It responds to the Identification test under Halcinonide Cream.

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.

4 Assay

4.1 Mobile phase

Mix approximately equal volumes of acetonitrile and water, adjusting the ratio of solvents as necessary to achieve acceptable chromatography.

4.2 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.

4.3 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.

4.4 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.

4.5 Chromatographic system and Procedure

Proceed as directed in the Assay under Halcinonide Cream. Calculate the quantity, in mg, of C₂₄H₃₂CIFO₅ in the portion of Topical Solution taken by the formula:

50C(R_U/R_S)

in which the terms are as defined therein.