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 90.0percent and not more than 115.0percent of the labeled amount of C25H31FO8.
Packaging and storage— Preserve in single-dose or in multiple-dose containers,preferably of Type Iglass.
Identification— Filter a volume of Injectable Suspension,equivalent to about 50mg of triamcinolone diacetate,through a medium-porosity,sintered-glass funnel,wash with water,and dry the crystals in vacuum at 60for 1hour.Dissolve 2mg of the dried crystals in 1mLof 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 Identificationtest Aunder Triamcinolone Diacetate.
Bacterial endotoxins á85ñ— It contains not more than 7.1USP Endotoxin Units per mg of triamcinolone diacetate.
Uniformity of dosage units á905ñ: meets the requirements.
pHá791ñ: between 4.5and 7.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
0.005M Monobasic sodium phosphate solution,Mobile phase,Standard preparation,System suitability preparation,and Chromatographic system— Proceed as directed in the Assayunder Triamcinolone Diacetate.
Assay preparation— Quantitatively transfer an accurately measured portion of Injectable Suspension,equivalent to about 50mg of triamcinolone diacetate,to a 100-mLvolumetric flask.Dilute with Mobile phaseto volume,and mix.Pipet 2mLof this solution into a 25-mLvolumetric flask,dilute with Mobile phaseto volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Triamcinolone Diacetate.Calculate the quantity,in mg,of C25H31FO8in the portion of Injectable Suspension taken by the formula:
1.25C(rU/rS),
in which Cis the concentration,in µg per mL,of USP Triamcinolone Diacetate RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1963
Phone Number:1-301-816-8139