Amcinonide

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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C₂₈H₃₅FO₇ 502.57

Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-16,17-[cyclopentylidenebis(oxy)]-9-fluoro-11-hydroxy-, (11β,16α)-;9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with cyclopentanone, 21-acetate CAS RN®: 51022-69-6;

UNII: 423W026MA9.

1 DEFINITION

Amcinonide contains NLT 97.0% and NMT 102.0% of amcinonide (C₂₈H₃₅FO₇), calculated on the dried basis.

2 IDENTIFICATION

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A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)

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B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay. (USP1-Aug-2019)

3 ASSAY

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3.1 Procedure

Solution A: Acetonitrile and water (35:65) (USP 1-Aug-2019)

Solution B: Acetonitrile and water (70:30) (USP 1-Aug-2019)

Mobile phase: See Table 1. Equilibrate the system with Solution A.

Table 1

System suitability solution: 12.5 μg/mL of USP Butylparaben RS (USP 1-Aug-2019) and 20 μg/mL of USP Amcinonide RS in Solution B

Standard solution: 0.02 mg/mL of USP Amcinonide RS in Solution B

Sample solution: 0.02 mg/mL of Amcinonide in Solution B. Sonicate for 5 min.

3.2 Chromatographic system

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm × 25-cm; 5-μm (USP 1-Aug-2019) packing L1

Flow rate: 2 mL/min

Injection volume: 10 μL

3.3 System suitability

Samples: System suitability solution and Standard solution

[Note - The relative retention times for butylparaben and amcinonide are 0.78 and 1.0, respectively.]

3.4 Suitability requirements

Resolution: NLT 8.0 between butylparaben and amcinonide, System suitability solution

Tailing factor: NMT 1.5, Standard solution

Relative standard deviation: NMT 2.0%, Standard solution

3.5 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of amcinonide (C₂₈H₃₅FO₇) in the portion of Amcinonide taken:

Result = (r_u/r_s) × (C_s/C_u) × 100

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

C_s = concentration of USP Amcinonide RS in the Standard solution (mg/mL)

C_u = concentration of Amcinonide in the Sample solution (mg/mL)

Acceptance criteria: 97.0% - 102.0% on the dried basis

4 SPECIFIC TESTS

Optical Rotation 〈781S〉, Procedures, Specific Rotation

Sample solution: 10 mg/mL of Amcinonide in chloroform

Acceptance criteria: +89.4° to +94.0°

Loss on Drying 〈731〉

Sample: Amcinonide

Analysis: Dry the Sample at 105° for 4 h.

Acceptance criteria: NMT 1.0%

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in well-closed containers.

Change to read:

USP Reference Standards 〈11〉

USP Amcinonide RS

USP Butylparaben RS