Amcinonide Cream
» Amcinonide Cream is Amcinonide in a suitable cream base. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of amcinonide (C28H35FO7).
Packaging and storage— Preserve in tight containers.
Identification— Place 2 g of the Cream in a 150-mL beaker, add 50 mL of chloroform and 15 g of anhydrous sodium sulfate, and stir with a glass rod to dissolve the specimen. Filter the solution, and clarify the filtrate, if necessary, by the further addition of anhydrous sodium sulfate and a second filtration. Evaporate the filtrate to dryness, and dissolve the residue in chloroform to obtain a solution containing about 100 µg of amcinonide per mL. Apply 25 µL of this solution, and 25 µL of a solution of USP Amcinonide RS in chloroform containing 100 µg per mL, on a line parallel to and about 3 cm from the bottom edge of a thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel. Place the plate in a developing chamber containing and equilibrated with ether. Develop the chromatogram until the solvent front has moved about 12 cm above the line of application. Remove the plate, allow the solvent to evaporate, and locate the spots on the plate by viewing under short-wavelength UV light: the intensity and the RF value of the principal spot obtained from the solution under test are similar to those of the spot obtained from the Standard solution.
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.
Minimum fill 755: meets the requirements.
pH 791: between 3.5 and 5.2.
Solution A, Solution B, Mobile phase, System suitability solution, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Amcinonide.
Assay preparation— Transfer an accurately weighed quantity of Cream, equivalent to about 10 mg of Amcinonide, to a 50-mL volumetric flask, add 5 mL of Solution B and 15 mL of acetonitrile, and heat over a steam bath until dissolved. Add 20 mL of Solution B while hot, cool to room temperature, dilute with Solution B to volume, and refrigerate for 30 minutes. Vigorously shake the solution to disperse the mixture, and filter while cold. Transfer 5 mL of this solution to a 50-mL volumetric flask, dilute with Solution B to volume, and mix.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation. Record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of amcinonide (C28H35FO7) in the portion of Cream taken by the formula:
500C(rU / rS)
in which C is the concentration, in mg per mL, of USP Amcinonide RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
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USP32–NF27 Page 1506
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.