» 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.
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. [noteSonicate 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 preparationPrepare 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.Chromatographic Column
USP32NF27 Page 3765
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.