Triamcinolone Hexacetonide
C30H41FO7 532.64
Pregna-1,4-diene-3,20-dione, 21-(3,3-dimethyl-1-oxobutoxy)-9-fluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11
,16
)-;
9-Fluoro-11,16,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone 21-(3,3-dimethylbutyrate)
[5611-51-8].
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C30H41FO7 532.64
Pregna-1,4-diene-3,20-dione, 21-(3,3-dimethyl-1-oxobutoxy)-9-fluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11
,16)-;
9-Fluoro-11
,16,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone 21-(3,3-dimethylbutyrate)
[5611-51-8].DEFINITION
Triamcinolone Hexacetonide contains NLT 97.0% and NMT 102.0% of C30H41FO7, calculated on the dried basis.
IDENTIFICATION
ASSAY
• Procedure
Mobile phase:
Methanol and water (3:1)
System suitability solution:
0.4 mg/mL each of USP Triamcinolone Acetonide RS and USP Triamcinolone Hexacetonide RS in methanol
Standard solution:
0.4 mg/mL of USP Triamcinolone Hexacetonide RS in methanol
Sample solution:
0.4 mg/mL of Triamcinolone Hexacetonide in methanol
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
4.6-mm × 25-cm; packing L1
Flow rate:
2 mL/min
Injection size:
10 µL
System suitability
Sample:
System suitability solution
[Note—The relative retention times for triamcinolone acetonide and triamcinolone hexacetonide are 0.27 and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 7.5 between triamcinolone acetonide and triamcinolone hexacetonide
Tailing factor:
NMT 1.3 for triamcinolone hexacetonide
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C30H41FO7 in the portion of Triamcinolone Hexacetonide taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = concentration of USP Triamcinolone Hexacetonide RS in the Standard solution (mg/mL) |
| CU | = | = concentration of Triamcinolone Hexacetonide in the Sample solution (mg/mL) |
Acceptance criteria:
97.0%–102.0% on the dried basis
IMPURITIES
Inorganic Impurities
• Heavy Metals, Method II 
231
:
NMT 20 ppm
231:
NMT 20 ppm
Organic Impurities
• Procedure: Limit of Triamcinolone Acetonide
Mobile phase, System suitability solution, Sample solution, Chromatographic system, and System suitability:
Proceed as directed in the Assay.
Standard solution:
0.004 mg/mL of USP Triamcinolone Acetonide RS in methanol
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of triamcinolone acetonide in the portion of Triamcinolone Hexacetonide taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of triamcinolone acetonide from the Sample solution |
| rS | = | = peak response of triamcinolone acetonide from the Standard solution |
| CS | = | = concentration of USP Triamcinolone Acetonide RS in the Standard solution (mg/mL) |
| CU | = | = concentration of Triamcinolone Hexacetonide in the Sample solution (mg/mL) |
Acceptance criteria:
NMT 1.0%
SPECIFIC TESTS
• Optical Rotation, Specific Rotation 781S
781S
Sample solution:
10 mg/mL in chloroform
Acceptance criteria:
+91
to +98
to +98
• Loss on Drying 731:
Dry a sample in a vacuum at 60 for 4 h: it loses NMT 2.0% of its weight.
731:
Dry a sample in a vacuum at 60 for 4 h: it loses NMT 2.0% of its weight.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers. Store at room temperature.
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Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Mary S. Waddell
Scientific Liaison 1-301-816-8124 |
(SM42010) Monographs - Small Molecules 4 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4928
Pharmacopeial Forum: Volume No. 36(5) Page 1216