Glycine (glye' seen). DEFINITION Glycine contains NLT 98.5% and NMT 101.5% of glycine (C2H5NO2), calculated on the dried basis. IDENTIFICATION ASSAY • Procedure Sample: 150 mg of Glycine Blank: 100 mL of glacial acetic acid Titrimetric system (See Titrimetry 541.) Mode: Direct titration Titrant: 0.1 N perchloric acid VS Endpoint detection: Visual Analysis: Dissolve the Sample in 100 mL of glacial acetic acid, and add 1 drop of crystal violet TS. Titrate with the Titrant to a green endpoint. Perform the Blank determination. Calculate the percentage of glycine (C2H5NO2) in the Sample taken: Result = {[(VS VB) × N × F]/W} × 100
Acceptance criteria: 98.5%101.5% on the dried basis IMPURITIES • Residue on Ignition 281: NMT 0.1% • Chloride and Sulfate, Chloride 221 Standard solution: 0.10 mL of 0.020 N hydrochloric acid Sample: 1 g of Glycine Acceptance criteria: NMT 0.007% • Chloride and Sulfate, Sulfate 221 Standard solution: 0.20 mL of 0.020 N sulfuric acid Sample: 3 g of Glycine Acceptance criteria: NMT 0.0065% • Heavy Metals, Method I 231: NMT 20 ppm • Hydrolyzable Substances Sample solution: 100 mg/mL of Glycine Analysis: Boil 10 mL of the Sample solution for 1 min, and set aside for 2 h. Acceptance criteria: The solution appears as clear and as mobile as 10 mL of the same solution that has not been boiled. SPECIFIC TESTS • Loss on Drying 731: Dry a sample at 105 for 2 h: it loses NMT 0.2% 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 3355 Chromatographic Column Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30. |