Tolazamide Tablets

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

Tolazamide Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C₁₄H₂₁N₃O₃S.

1 Packaging and storage

Preserve in tight containers.

1.1 USP Reference standards 〈11〉

USP Tolazamide RS

2 Identification

Triturate a quantity of Tablets, equivalent to about 250 mg of tolazamide, with 50 mL of chloroform, and filter. Evaporate the filtrate to dryness, and dry in vacuum at 60° for 3 hours: the residue so obtained responds to Identification test A under Tolazamide.

2.1 Dissolution 〈711〉

Medium: 0.05 M Tris(hydroxymethyl)aminomethane, pH 7.6, adjusted, if necessary, with hydrochloric acid to a pH of 7.6; 900 mL.

Apparatus 2: 75 rpm.

Time: 30 minutes.

Procedure-Determine the amount of C₁₄H₂₁N₃O₃S dissolved from UV absorbances at the wavelength of maximum absorbance at about 224 nm of filtered portions of the solution under test, suitably diluted with Dissolution Medium, in comparison with a Standard solution having a known concentration of USP Tolazamide RS in the same medium. [Note—Sonicate the Standard solution until the Reference Standard is dissolved.]

Tolerances-Not less than 70% (Q) of the labeled amount of C₁₄H₂₁N₃O₃S is dissolved in 30 minutes.

Uniformity of dosage units 〈905〉: meet the requirements.

3 Assay

Internal standard preparation, Mobile phase, and Standard preparation-Prepare as directed in the Assay under Tolazamide.

Assay preparation-Weigh and finely powder not less than 10 Tablets. Weigh accurately a portion of the powder, equivalent to about 300 mg of tolazamide, and transfer to a suitable container. Add 100.0 mL of Internal standard solution and about 20 glass beads. Securely close the container, and shake vigorously for approximately 30 minutes. Centrifuge, and use the clear liquid as the Assay preparation.

Procedure-Proceed as directed for Procedure in the Assay under Tolazamide. Calculate the quantity, in mg, of C₁₄H₂₁N₃O₃S in the portion of Tablets taken by the formula:

100C(Rᵤ/Rₛ)

in which the terms are as defined therein.