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Tinidazole
» Tinidazole contains not less than 98.0 percent and not more than 101.0 percent of C8H13N3O4S, calculated on the dried basis.
Packaging and storage
Preserve in tight containers, protected from light, at controlled room temperature.
USP Reference standards
USP Tinidazole RS. USP Tinidazole Related Compound A RS. USP Tinidazole Related Compound B RS.
Identification
C:
The RF value and intensity of the principal spot obtained from the chromatogram of Test solution 2 correspond to those obtained from the chromatogram of Standard solution 1, as obtained in the test for Related compounds.
Loss on drying
Residue on ignition
Heavy metals, Method II
Related compounds
Adsorbent:
0.25-mm layer of chromatographic silica gel mixture.
Test solution 1
Dissolve about 200 mg of Tinidazole, accurately weighed, in 10 mL of methanol.
Test solution 2
Transfer 1.0 mL of Test solution 1 to a 10-mL volumetric flask, dilute with methanol to volume, and mix.
Standard solution 1
Prepare a solution of USP Tinidazole RS in methanol containing 2.0 mg per mL.
Standard solution 2
Dilute 1.0 mL of Standard solution 1 with methanol to 20 mL.
Standard solution 3
Dilute 4.0 mL of Standard solution 2 with methanol to 10 mL.
Standard solution 4
Prepare a solution of USP Tinidazole Related Compound A RS in methanol containing 0.1 mg per mL.
Standard solution 5
Prepare a solution of USP Tinidazole Related Compound B RS in methanol containing 0.1 mg per mL.
Application volume:
10 µL.
Developing solvent system:
a mixture of ethyl acetate and butyl alcohol (3:1).
Procedure
Proceed as directed for Thin-Layer Chromatography under Chromatography
Assay
Dissolve 150 mg of Tinidazole, accurately weighed, in 25.0 mL of glacial acetic acid, and titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically with suitable electrodes (see Titrimetry
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP32NF27 Page 3750
Pharmacopeial Forum: Volume No. 27(1) Page 1820
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