Triamcinolone Hexacetonide Injectable Suspension
DEFINITION
Triamcinolone Hexacetonide Injectable Suspension is a sterile suspension of Triamcinolone Hexacetonide in a suitable aqueous medium. It contains NLT 90.0% and NMT 115.0% of the labeled amount of triamcinolone hexacetonide (C30H41FO7).
IDENTIFICATION
• Infrared Absorption 
197K
197K
Sample:
Place a volume of Injectable Suspension, equivalent to 25 mg of triamcinolone hexacetonide, and 2 mL of water in a membrane filter of 0.20-µm pore size. Apply vacuum to the filter, wash the residue with two 5-mL portions of water, and air-dry the filter and the precipitate. Place the dried filter and precipitate in a small beaker with 5 mL of alcohol, and dissolve the precipitate. Decant the alcohol solution into a small beaker and evaporate with the aid of low heat and a current of air to dryness.
Acceptance criteria:
Meets the requirements
ASSAY
• Procedure
Mobile phase:
Methanol and water (3:1)
System suitability solution:
0.3 mg/mL of amcinonide and 0.4 mg/mL of USP Triamcinolone Hexacetonide RS in methanol
Standard solution:
0.4 mg/mL of USP Triamcinolone Hexacetonide RS in methanol
Sample solution:
Using a “to contain” pipet, transfer a volume of Injectable Suspension, equivalent to 40 mg of triamcinolone hexacetonide, to a 100-mL volumetric flask. Rinse the pipet with methanol, collecting the rinse in the volumetric flask. Dilute with methanol to volume.
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
4.6-mm × 25-cm; packing L1
Flow rate:
1.4 mL/min
Injection size:
10 µL
System suitability
Sample:
System suitability solution
[Note—The relative retention times for amcinonide and triamcinolone hexacetonide are about 0.50 and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 10 between amcinonide and triamcinolone hexacetonide
Tailing factor:
NMT 1.2 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 Injectable Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
| rU | = | = peak response of triamcinolone hexacetonide from the Sample solution |
| rS | = | = peak response of triamcinolone hexacetonide from the Standard solution |
| CS | = | = concentration of USP Triamcinolone Hexacetonide RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of triamcinolone hexacetonide in the Sample solution (mg/mL) |
Acceptance criteria:
90.0%–115.0%
PERFORMANCE TESTS
• Uniformity of Dosage Units 905:
Meets the requirements
905:
Meets the requirements
IMPURITIES
Organic Impurities
• Procedure: Limit of Triamcinolone Acetonide
Mobile phase, Sample solution, and Chromatographic system:
Proceed as directed in the Assay.
System suitability solution:
0.4 mg/mL each of USP Triamcinolone Acetonide RS and USP Triamcinolone Hexacetonide RS in methanol
Standard solution:
0.004 mg/mL of USP Triamcinolone Acetonide RS in methanol
System suitability
Sample:
System suitability solution
Suitability requirements
Resolution:
NLT 7.5 between triamcinolone acetonide and triamcinolone hexacetonide
Tailing factor:
NMT 1.2 for triamcinolone hexacetonide
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of triamcinolone acetonide in the portion of Injectable Suspension 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 | = | = nominal concentration of triamcinolone hexacetonide in the Sample solution (mg/mL) |
Acceptance criteria:
NMT 1.0%
SPECIFIC TESTS
• Bacterial Endotoxins Test 85:
It contains NMT 17.2 USP Endotoxin Units/mg of triamcinolone hexacetonide.
85:
It contains NMT 17.2 USP Endotoxin Units/mg of triamcinolone hexacetonide.
• pH 791:
4.0–8.0
791:
4.0–8.0
• Injections 1:
Meets the requirements
1:
Meets the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in single-dose or multiple-dose containers, preferably of Type I glass. Store at controlled room temperature. Do not freeze.
• USP Reference Standards 11
11
USP Endotoxin RS
USP Triamcinolone Acetonide RS 
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USP Triamcinolone Hexacetonide RS
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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 |
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4929
Pharmacopeial Forum: Volume No. 36(5) Page 1217