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.
Other requirements
It meets the requirements under
Injections 1.
Assay
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 C
25H
31FO
8 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.