Packaging and storage— Preserve in well-closed containers.

USP Reference standards 11— USP Triamcinolone Acetonide RS.

Identification— Place 2 g of Ointment in a conical flask, add 5.0 mL of chloroform, and shake for 10 minutes. Add 15 mL of alcohol, and shake for an additional 10 minutes. Filter the solution into a centrifuge tube, and evaporate the filtrate to dryness. Dissolve the residue in alcohol to obtain a solution containing about 250 µg per mL. Apply 10 µL of this solution, and 10 µL of a solution of USP Triamcinolone Acetonide RS in alcohol containing 250 µg per mL, on a line parallel to and about 1.5 cm from the bottom edge of a thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel. Place the plate in a developing chamber containing and equilibrated with a mixture of chloroform, benzene, and methanol (100:40:20). Develop the chromatogram until the solvent front has moved about 12 cm above the line of application. Remove the plate, allow the solvent to evaporate, and spray with a mixture of equal volumes of sodium hydroxide solution (1 in 5) and a 1 in 500 solution of blue tetrazolium in methanol: the intensity of the blue color and the RF of the spot obtained from the solution under test are similar to those of the spot obtained from the Standard solution.

Microbial limits 61— It meets the requirements of the tests for absence of Staphylococcus aureus and Pseudomonas aeruginosa.

Minimum fill 755: meets the requirements.

Residual solvents 467: meets the requirements.

Assay— Proceed with Ointment as directed in the Assay under Triamcinolone Acetonide Cream, except to read “Ointment” in place of “Cream” throughout.

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 2185

Phone Number : 1-301-816-8143