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 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— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
Scientist
1-301-816-8139
(MDCCA05) Monograph Development-Cough Cold and Analgesics
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 2547
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.