Tolazamide Tablets
» Tolazamide Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C14H21N3O3S.
Packaging and storage—
Preserve in tight containers.
USP Reference standards 
11
—
11—
USP Tolazamide RS 
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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.
for 3 hours: the residue so obtained responds to Identification test A under Tolazamide.
Dissolution 711—
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.
905:
meet the requirements.
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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Elena Gonikberg, Ph.D.
Principal Scientific Liaison 1-301-816-8251 |
(SM32010) Monographs - Small Molecules 3 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
|
| 711 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
USP35–NF30 Page 4889