Packaging and storage—
Preserve in tight containers.
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.
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 C
14H
21N
3O
3S 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.
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 C
14H
21N
3O
3S in the portion of Tablets taken by the formula:
100C(RU / RS),
in which the terms are as defined therein.
