Triamcinolone Acetonide Injectable Suspension
» Triamcinolone Acetonide Injectable Suspension is a sterile suspension of Triamcinolone Acetonide 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 C24H31FO6.
Packaging and storage Preserve in single-dose or in multiple-dose containers, preferably of Type I glass, protected from light.
Identification Extract a volume of Injectable Suspension, equivalent to about 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 hour: the triamcinolone acetonide so obtained responds to the Identification tests under Triamcinolone Acetonide.
Bacterial endotoxins 85 It contains not more than 4.4 USP Endotoxin Units per mg of triamcinolone acetonide.
pH 791: between 5.0 and 7.5.
Other requirements It meets the requirements under Injections 1.
Mobile phase: approximately 30% acetonitrile in water.
Internal standard solution Dissolve fluoxymesterone in methanol to obtain a solution having a concentration of about 84 µg per mL.
Standard preparation Dissolve an accurately weighed quantity of USP Triamcinolone Acetonide RS in methanol to obtain a solution having a known concentration of about 200 µg per mL. Pipet 20 mL of this solution into a 50-mL volumetric flask, dilute with Internal standard solution to volume, and mix. The Standard preparation has a known concentration of about 80 µg of USP Triamcinolone Acetonide RS per mL.
Assay preparation Dissolve an accurately measured volume of freshly mixed Injectable Suspension in methanol, and dilute quantitatively with methanol to obtain a solution having an expected concentration of about 200 µg of triamcinolone acetonide per mL. Pipet 20 mL of this solution into a 50-mL volumetric flask, dilute with Internal standard solution to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Triamcinolone Acetonide Cream, except to use peak responses in the calculation. Calculate the quantity, in mg, of C24H31FO6 in each mL of the Injectable Suspension taken by the formula:
(CD / V)(RU / RS)in which C is the concentration, in mg per mL, of USP Triamcinolone Acetonide RS in the Standard preparation, D is the dilution factor used in the Assay preparation, V is the volume, in mL, of Injectable Suspension taken, and RU and RS are the ratios of the peak responses of triamcinolone acetonide to the internal standard, obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 3784
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.