U.S. PHARMACOPEIA

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Triamcinolone Acetonide Dental Paste
» Triamcinolone Acetonide Dental Paste is Triamcinolone Acetonide in a suitable emollient paste. 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 tight containers.
Identification— It responds to the Identification test under Triamcinolone Acetonide Cream.
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.
(Official January 1, 2007)
Assay—
Mobile phase— Prepare as directed in the Assay under Triamcinolone Acetonide Cream.
Internal standard solution and Standard preparation—Prepare as directed in the Assay under Triamcinolone Acetonide Cream.
Assay preparation— Transfer an accurately weighed quantity of Dental Paste, equivalent to about 1.5 mg of triamcinolone acetonide, to a screw-cap tube. Add 20.0 mL of Internal standard solution, cap, and place in a sonic bath for 15 to 20 minutes. Place in a water bath at 70 for 5 minutes, then swirl for 1 minute. Repeat the heating and swirling sequence once. Cool in an ice–methanol bath for 15 minutes, then centrifuge for 10 minutes at 5. Mix an accurately measured volume of the supernatant with an equal volume of Mobile phase. Place in an ice–methanol bath for 15 minutes, then centrifuge for 15 minutes. Draw off and discard the upper phase. Filter the lower phase to obtain a clear solution.
Procedure— Proceed as directed for Procedure in the Assay under Triamcinolone Acetonide Cream.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 2186
Phone Number : 1-301-816-8143