Alclometasone Dipropionate Ointment

Printed on: Sat Jun 26 2021, 06:10:15 AM Official Status: Currently Official on 26-Jun-2021 DocId: 1_GUID-C7285951-BB6A-4897-A6E5-D446C5D9F4BE_2_en-US

(EST)
Printed by: Nguyen Nhan Official Date: Official Prior to 2013 Document Type: USP @2021 USPC
1

50-mL centrifuge tube, add 10 mL of

Alclometasone Dipropionate Ointment 2,2,4-trimethylpentane, insert a stopper securely into the
DEFINITION tube, and disperse the specimen using a vortex mixer. Add
Alclometasone Dipropionate Ointment contains NLT 90.0% 5.0 mL of Internal standard solution and 5.0 mL of Solution
and NMT 110.0% of the labeled amount of alclometasone A, insert the stopper securely, shake vigorously for 2 min,
dipropionate (C28H37ClO7) in a suitable ointment base. and centrifuge at 2500 rpm for 3 min. Remove the lower,
aqueous alcohol phase, and transfer this Sample solution
IDENTIFICATION to a stoppered vial.
• A. The retention time of the major peak of the Sample Chromatographic system
solution corresponds to that of the Standard solution, both (See Chromatography á621ñ, System Suitability.)
relative to the internal standard, as obtained in the Assay. Mode: LC
• B. THIN-LAYER CHROMATOGRAPHIC IDENTIFICATION TEST Detector: UV 254 nm
á201ñ Column: 4-mm × 30-cm; packing L1
Standard solution: 0.25 mg/mL USP Alclometasone Flow rate: 1.2 mL/min
Dipropionate RS in methanol Injection volume: 20 µL
Sample solution: Place a quantity of Ointment, equivalent System suitability
to 1.25 mg of alclometasone dipropionate, in a 50-mL Sample: Standard solution
centrifuge tube, add 10 mL of 2,2,4-trimethylpentane, [NOTE—The relative retention times for alclometasone
insert a stopper securely into the tube, and disperse the dipropionate and betamethasone dipropionate are
specimen using a vortex mixer. Add 5.0 mL of a solution of about 0.7 and 1.0, respectively.]
methanol in water (45 in 50), insert the stopper securely, Suitability requirements
shake vigorously for 2 min, and centrifuge at 2500 rpm for Resolution: NLT 3.0 between the analyte and internal
al
3 min. Remove the lower, aqueous alcohol phase, and standard peaks
transfer to a stoppered vial. Relative standard deviation: NMT 2%
Chromatographic system Analysis
(See Chromatography á621ñ, Thin-Layer Chromatography.) Samples: Standard solution and Sample solution
Adsorbent: 0.25-mm layer of chromatographic silica gel Calculate the percentage of the labeled amount of
mixture alclometasone dipropionate (C28H37ClO7) in the portion of
Application volume: 20 µL
Developing solvent system: Chloroform and acetone
(7:1)
ci Ointment taken:
Result = (RU/RS) × (CS/CU) × 100

Analysis
Samples: Standard solution and Sample solution RU = peak height ratio of alclometasone dipropionate
ffi
Dry the applications with the aid of a stream of nitrogen, to the internal standard from the Sample solution
and develop the chromatograms in a saturated, unlined RS = peak height ratio of alclometasone dipropionate
chromatographic chamber. When the solvent front has to the internal standard from the Standard
moved three-fourths of the length of the plate, remove solution
the plate from the chamber, mark the solvent front, and CS = concentration of USP Alclometasone
allow the solvent to evaporate. Observe the plate under Dipropionate RS in the Standard solution
O
short-wavelength UV light. (mg/mL)

Acceptance criteria: The RF value of the principal spot CU = nominal concentration of alclometasone
obtained from the Sample solution corresponds to that of dipropionate in the Sample solution (mg/mL)
the Standard solution.
Acceptance criteria: 90.0%–110.0%
ASSAY
• PROCEDURE PERFORMANCE TESTS
Buffer: 6.80 g/L of monobasic potassium phosphate • MINIMUM FILL á755ñ: Meets the requirements
(0.05 M) SPECIFIC TESTS
Solution A: Dilute 450 mL of methanol with water to • MICROBIAL ENUMERATION TESTS á61ñ and TESTS FOR
500 mL. SPECIFIED MICROORGANISMS á62ñ: Meets the requirements
Mobile phase: Methanol and Buffer (2:1) of the tests for absence of Staphylococcus aureus and
Internal standard solution: 0.15 mg/mL of betamethasone Pseudomonas aeruginosa
dipropionate in Solution A
Standard stock solution: 0.1 mg/mL of USP Alclometasone ADDITIONAL REQUIREMENTS
Dipropionate RS in Solution A • PACKAGING AND STORAGE: Preserve in collapsible tubes or
Standard solution: 0.05 mg/mL of USP Alclometasone tight containers, and store at controlled room temperature.
Dipropionate RS obtained by combining, in a small • USP REFERENCE STANDARDS á11ñ
stoppered flask, 5.0 mL of Standard stock solution and USP Alclometasone Dipropionate RS
5.0 mL of Internal standard solution
Sample solution: Transfer a quantity of Ointment,
equivalent to 0.5 mg of alclometasone dipropionate, to a
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Alclometasone Dipropionate Ointment

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Printed on: Sat Jun 26 2021, 06:10:15 AM Official Status: Currently Official on 26-Jun-2021 DocId: 1_GUID-C7285951-BB6A-4897-A6E5-D446C5D9F4BE_2_en-US

50-mL centrifuge tube, add 10 mL of

Result = (RU/RS) × (CS/CU) × 100

short-wavelength UV light. (mg/mL)

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