» Taurine contains not less than 98.5 percent and not more than 101.5 percent of C2H7NO3S, calculated on the dried basis.
Packaging and storage Preserve in well-closed containers.
USP Reference standards 11
USP Taurine RS.
Identification, Infrared Absorption 197K.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 0.3% of its weight.
Residue on ignition 281: not more than 0.3%.
Chloride 221 A 0.7-g portion shows no more chloride than corresponds to 0.50 mL of 0.020 N hydrochloric acid. Not more than 0.05% is found.
Sulfate 221 A 0.8-g portion shows no more sulfate than corresponds to 0.25 mL of 0.020 N sulfuric acid. Not more than 0.03% is found.
Iron 241: 0.003%.
Heavy metals, Method I 231: 0.0015%.
Adsorbent: 0.25-mm layer of chromatographic silica gel mixture.
Test solution Dissolve an accurately weighed quantity of Taurine with water to obtain a solution having a concentration of about 10 mg per mL.
Standard solution Dissolve an accurately weighed quantity of USP Taurine RS with water to obtain a solution having a known concentration of about 0.05 mg per mL, equivalent concentration to about 0.5% of the Test solution.
Application volume: 5 µL.
Developing solvent system: a mixture of butyl alcohol, glacial acetic acid, and water (60:20:20).
Spray reagent Dissolve 0.2 g ninhydrin in 100 mL of a mixture of butyl alcohol and 2 N acetic acid (95:5).
Procedure Proceed as directed for Thin-Layer Chromatography under Chromatography 621, except to dry the plate at 80 for 30 minutes. Spray the plate with Spray reagent, and heat at 80 for about 10 minutes. Examine the plate under white light: no secondary spot in the chromatogram of the Test solution is larger or more intense than the principal spot in the chromatogram of the Standard solution. Not more than 0.5% of individual impurities are found. [noteThe RF value for the taurine spots should be about 0.2.]
Assay Proceed as directed for Method II under Nitrogen Determination 461. Each mL of 0.01 N sulfuric acid is equivalent to 1.25 mg of C2H7NO3S.
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USP32NF27 Page 3654Pharmacopeial Forum: Volume No. 27(6) Page 3331