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.
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 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.
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.
Senior Scientist
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
Reference Standards Lili Wang, Technical Services Scientist
711 Margareth R.C. Marques, Ph.D.
Senior Scientist
(BPC05) Biopharmaceutics05
USP32–NF27 Page 3765
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.