Taurine
(taw' reen).
DEFINITION
Taurine contains NLT 98.5% and NMT 101.5% of taurine (C2H7NO3S), calculated on the dried basis.
IDENTIFICATION
ASSAY
• Nitrogen Determination, Method II 461
Analysis:
Proceed as directed in the chapter. Each mL of 0.01 N sulfuric acid is equivalent to 1.25 mg of C2H7NO3S.
Acceptance criteria:
98.5%101.5% on the dried basis
IMPURITIES
• Residue on Ignition 281:
NMT 0.3%
• Chloride and Sulfate, Chloride 221
Standard:
0.50 mL of 0.020 N hydrochloric acid
Sample:
0.7 g of Taurine
Acceptance criteria:
NMT 0.05%
• Chloride and Sulfate, Sulfate 221
Standard:
0.25 mL of 0.020 N sulfuric acid
Sample:
0.8 g of Taurine
Acceptance criteria:
NMT 0.03%
• Iron 241:
NMT 30 ppm
• Heavy Metals, Method I 231:
NMT 15 ppm
• Related Compounds
Standard solution:
0.05 mg/mL of USP Taurine RS in water, an equivalent concentration of about 0.5% of the Sample solution
Sample solution:
10 mg/mL of Taurine in water
Chromatographic system
Mode:
TLC
Adsorbent:
0.25-mm layer of chromatographic silica gel mixture
Application volume:
5 µL
Developing solvent system:
Butyl alcohol, glacial acetic acid, and water (3:1:1)
Spray reagent:
2 mg/mL of ninhydrin in a mixture of butyl alcohol and 2 N acetic acid (95:5)
Analysis:
Dry the plate at 80 for 30 min. Spray the plate with Spray reagent, and heat at 80 for about 10 min. Examine the plate under white light. [NoteThe RF value for the taurine spots should be about 0.2. ]
Acceptance criteria:
No secondary spot of the Sample solution is larger or more intense than the principal spot of the Standard solution.
Individual impurities:
NMT 0.5%
SPECIFIC TESTS
• Loss on Drying 731:
Dry a sample at 105 for 3 h: it loses NMT 0.3% of its weight.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4755
Pharmacopeial Forum: Volume No. 27(6) Page 3331
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