Taurine
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Taurine [107-35-7].
»Taurine contains not less than 98.5percent and not more than 101.5percent of C2H7NO3S,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
USP Reference standards á11ñ—
USP Taurine RS.
Identification,
Infrared Absorption á197Kñ.
Loss on drying á731ñ—
Dry it at 105
for 3hours:it loses not more than 0.3%of its weight.
for 3hours:it loses not more than 0.3%of its weight.
Residue on ignition á281ñ:
not more than 0.3%.
Chloride á221ñ—
A0.7-g portion shows no more chloride than corresponds to 0.50mLof 0.020Nhydrochloric acid.Not more than 0.05%is found.
Sulfate á221ñ—
A0.8-g portion shows no more sulfate than corresponds to 0.25mLof 0.020Nsulfuric acid.Not more than 0.03%is found.
Iron á241ñ:
0.003%.
Heavy metals,Method Iá231ñ:
0.0015%.
Chromatographic purity—
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 10mg per mL.
Standard solution—
Dissolve an accurately weighed quantity of USP Taurine RSwith water to obtain a solution having a known concentration of about 0.05mg per mL,equivalent concentration to about 0.5%of the Test solution.
Application volume:
5µL.
Developing solvent system:
a mixture of butyl alcohol,glacial acetic acid,and water (60:20:20).
Spray reagent—
Dissolve 0.2g ninhydrin in 100mLof a mixture of butyl alcohol and 2Nacetic acid (95:5).
Procedure—
Proceed as directed for Thin-Layer Chromatographyunder Chromatography á621ñ,except to dry the plate at 80for 30minutes.Spray the plate with Spray reagent,and heat at 80for about 10minutes.Examine the plate under white light:no secondary spot in the chromatogram of the Test solutionis 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.[NOTE—The RFvalue for the taurine spots should be about 0.2.]
for 30minutes.Spray the plate with Spray reagent,and heat at 80for about 10minutes.Examine the plate under white light:no secondary spot in the chromatogram of the Test solutionis 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.[NOTE—The RFvalue for the taurine spots should be about 0.2.]
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Proceed as directed for Method IIunder Nitrogen Determination á461ñ.Each mLof 0.01Nsulfuric acid is equivalent to 1.25mg of C2H7NO3S.
Auxiliary Information—
Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 1849
Pharmacopeial Forum:Volume No.27(6)Page 3331
Phone Number:1-301-816-8389