(al'' kloe met' a sone dye proe' pee oh nate).
Pregna-1,4-diene-3,20-dione, 7-chloro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (7,11,16)-;
7-Chloro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate [66734-13-2].
Alclometasone Dipropionate contains NLT 97.0% and NMT 102.0% of C28H37ClO7, calculated on the dried basis.
• B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, both relative to the Internal standard solution, as obtained in the Assay.
Solution A: 6.80 mg/mL of monobasic potassium phosphate (0.05 M)
Mobile phase: Methanol and Solution A (2:1)
Internal standard solution: 2 mg/mL of betamethasone dipropionate in methanol
Standard stock solution: 1.2 mg/mL of USP Alclometasone Dipropionate RS in methanol
Standard solution: 4.0 mL of Standard stock solution and 4.0 mL of Internal standard solution. Dilute with methanol to 25 mL. [NoteThis solution contains approximately 0.2 mg/mL of USP Alclometasone Dipropionate RS. ]
Sample stock solution: 1.2 mg/mL of Alclometasone Dipropionate in methanol
Sample solution: 4 mL of Sample stock solution and 4 mL of Internal standard solution. Dilute with methanol to 25 mL.
Detector: UV 254 nm
Column: 4-mm × 30-cm; packing L1
Flow rate: 1.2 mL/min
Injection size: 10 µL
Sample: Standard solution
[NoteThe relative retention times for alclometasone dipropionate and betamethasone dipropionate are about 0.7 and 1.0, respectively. ]
Resolution: NLT 3.0 between the analyte and the Internal standard solution peaks
Relative standard deviation: NMT 2%
Samples: Standard solution and Sample solution
Calculate the percentage of C28H37ClO7 in the portion of Alclometasone Dipropionate taken:
Result = (RU/RS) × (CS/CU) × 100
Acceptance criteria: 97.0%102.0% on the dried basis
Mobile phase: Acetonitrile and water (3:2)
Diluent: Acetonitrile and water (2:1)
System suitability solution: 1.5 mg/mL of USP Alclometasone Dipropionate RS and 0.015 mg/mL of USP Alclometasone Dipropionate Related Compound A RS in Diluent
Sample solution: 1.5 mg/mL of Alclometasone Dipropionate in Diluent
Detector: UV 254 nm
Column: 4.6-mm × 15-cm; 5-µm packing L1
Flow rate: 1 mL/min
Injection size: 5 µL
Run time: Three times the retention time of alclometasone
Sample: System suitability solution
Tailing factor: NMT 1.5 for alclometasone dipropionate
Relative standard deviation: NMT 2.0% for alclometasone dipropionate
Resolution: NLT 2.0 between alclometasone dipropionate and alclometasone dipropionate related compound A
Sample: Sample solution
Calculate the percentage of each impurity in the portion of Alclometasone Dipropionate taken:
Result = (rU/rT) × (1/F) × 100
Individual impurities: See Impurity Table 1.
Total impurities: NMT 2.0%
• Optical Rotation, Specific Rotation 781S
Sample solution: 30 mg/mL in dioxane
Acceptance criteria: +21 to +25
• Loss on Drying 731: Dry a sample in a vacuum at a pressure not exceeding 5 mm of mercury at 105 for 3 h: it loses NMT 0.5% of its weight.
• Packaging and Storage: Preserve in tight containers, and store at controlled room temperature.
• USP Reference Standards 11
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USP35NF30 Page 2086Pharmacopeial Forum: Volume No. 36(5) Page 1156