Triamcinolone Diacetate Injectable Suspension
» Triamcinolone Diacetate Injectable Suspension is a sterile suspension of Triamcinolone Diacetate in a suitable aqueous medium. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of C25H31FO8.
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
Identification— Filter a volume of Injectable Suspension, equivalent to about 50 mg of triamcinolone diacetate, through a medium-porosity, sintered-glass funnel, wash with water, and dry the crystals in vacuum at 60 for 1 hour. Dissolve 2 mg of the dried crystals in 1 mL of methanol in a small mortar. Evaporate with the aid of gentle heat and a stream of nitrogen to dryness: the crystals so obtained respond to Identification test A under Triamcinolone Diacetate.
Bacterial endotoxins 85 It contains not more than 7.1 USP Endotoxin Units per mg of triamcinolone diacetate.
Uniformity of dosage units 905: meets the requirements.
pH 791: between 4.5 and 7.5.
Other requirements— It meets the requirements under Injections 1.
0.005 M Monobasic sodium phosphate solution, Mobile phase, Standard preparation, System suitability preparation, and Chromatographic system— Proceed as directed in the Assay under Triamcinolone Diacetate.
Assay preparation— Quantitatively transfer an accurately measured portion of Injectable Suspension, equivalent to about 50 mg of triamcinolone diacetate, to a 100-mL volumetric flask. Dilute with Mobile phase to volume, and mix. Pipet 2 mL of this solution into a 25-mL volumetric flask, dilute with Mobile phase to volume, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Triamcinolone Diacetate. Calculate the quantity, in mg, of C25H31FO8 in the portion of Injectable Suspension taken by the formula:
1.25C(rU / rS)
in which C is the concentration, in µg per mL, of USP Triamcinolone Diacetate RS in the Standard preparation, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
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Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3786
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.