Triamcinolone Acetonide Injectable Suspension
DEFINITION
Triamcinolone Acetonide Injectable Suspension is a sterile suspension of Triamcinolone Acetonide in a suitable aqueous medium. It contains NLT 90.0% and NMT 115.0% of the labeled amount of C24H31FO6.
IDENTIFICATION
• A. Infrared Absorption 
197K
197K
Sample:
Extract a volume of Injectable Suspension, equivalent to 50 mg of triamcinolone acetonide, with two 10-mL portions of peroxide-free ether, and discard the ether extracts. Filter with the aid of suction, wash with small portions of water, and dry the precipitate at 105
for 1 h.
for 1 h.
Acceptance criteria:
Meets the requirements
• B. Ultraviolet Absorption 197U
197U
Sample solution:
20 µg/mL in methanol, using the triamcinolone acetonide obtained from Identification test A
Acceptance criteria:
Meets the requirements
ASSAY
• Procedure
Mobile phase:
Acetonitrile and water (30:70)
Internal standard solution:
84 µg/mL of fluoxymesterone in methanol
Standard stock solution:
200 µg/mL of USP Triamcinolone Acetonide RS in methanol
Standard solution:
80 µg/mL of USP Triamcinolone Acetonide RS from the Standard stock solution diluted with Internal standard solution
Sample stock solution:
Dissolve a volume of freshly mixed Injectable Suspension in methanol to obtain a solution containing 200 µg/mL of triamcinolone acetonide.
Sample solution:
80 µg/mL of triamcinolone acetonide from the Sample stock solution diluted with Internal standard solution
Chromatographic system
Mode:
LC
Detector:
UV 254 nm
Column:
4-mm × 30-cm; packing L1
Flow rate:
1.0 mL/min
Injection size:
15–25 µL
System suitability
Sample:
Standard solution
Suitability requirements
Resolution:
NLT 2.0 between triamcinolone acetonide and fluoxymesterone
Relative standard deviation:
NMT 3.0% for five replicate injections
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C24H31FO6 in the portion of Injectable Suspension taken:
Result = (RU/RS) × (CS/CU) × 100
| RU | = | = peak response ratio of the triamcinolone acetonide peak to the internal standard peak from the Sample solution |
| RS | = | = peak response ratio of the triamcinolone acetonide peak to the internal standard peak from the Standard solution |
| CS | = | = concentration of USP Triamcinolone Acetonide RS in the Standard solution (mg/mL) |
| CU | = | = nominal concentration of triamcinolone acetonide 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
SPECIFIC TESTS
• Bacterial Endotoxins Test 85:
It contains NMT 4.4 USP Endotoxin Units/mg of triamcinolone acetonide.
85:
It contains NMT 4.4 USP Endotoxin Units/mg of triamcinolone acetonide.
• pH 791:
5.0–7.5
791:
5.0–7.5
• 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, protected from light. Store at controlled room temperature. Do not freeze.
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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 4926
Pharmacopeial Forum: Volume No. 36(5) Page 1215