Glycine CAS 56-40-6 (H-Gly-OH) Assay 98.5~101.5% Factory High Quality

USP35-NF30
DEFINITION
Glycine contains NLT 98.5% and NMT 101.5% of glycine (C2H5NO2), calculated on the dried basis.
IDENTIFICATION
A. INFRARED ABSORPTION <197M>
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 per chloric 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
VS = Titrant volume consumed by the Sample (mL)
VB = Titrant volume consumed by the Blank (mL)
N = actual normality of the Titrant (mEq/mL)
F = equivalency factor, 75.07 mg/mEq
W = Sample weight (mg)
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
• HEAVY METALS, Method I <231>: NMT 20 ppm
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.
• USP REFERENCE STANDARDS <11>
USP Glycine RS

Japanese Pharmacopoeia JP17
Glycine, when dried, contains not less than 98.5% of Glycine(C2H5NO2).
Description Glycine occurs as white, crystals orcrystalline powder. It has a sweet taste. It is freely soluble in water and in formic acid, and practically insoluble in ethanol (95). It shows crystal polymorphism.
Identification Determine the infrared absorption spectrum of Glycine, previously dried, as directed in the potassiumbromide disk method under Infrared Spectrophotometry <2.25>, and compare the spectrum with the Reference Spec-trum: both spectra exhibit similar intensities of absorption atthe same wave numbers. If any difference appears between the spectra, dissolve Glycine in water, evaporate the water todryness, and repeat the test with the residue.
pH <2.54> Dissolve 1.0 g of Glycine in 20 mL of water: thepH of the solution is between 5.6 and 6.6.
Purity
(1) Clarity and color of solution-Dissolve 1.0 gof Glycine in 10 mL of water: the solution is clear and color-less.
(2) Chloride <1.03>-Perform the test with 0.5 g of Glycine. Prepare the control solution with 0.30 mL of 0.01mol/L hydrochloric acid VS (not more than 0.021%)
(3) Sulfate <1.14>-Perform the test with 0.6 g of Glycine. Prepare the control solution with 0.35 mL of 0.005mol/L sulfuric acid VS (not more than 0.028z).
(4) Ammonium <1.02>-Perform the test using 0.25 g of Glycine. Prepare the control solution with 5.0 mL of Standard Ammonium Solution (not more than 0.02%).
(5) Heavy Metals <1.07>-Proceed with 1.0 g of Glycine according to Method 1, and perform the test. Prepare the control solution with 2.0 mL of Standard Lead Solution (notmore than 20 ppm).
(6) Arsenic <1.11>-Prepare the test solution with 1.0 gof Glycine according to Method 1, and perform the test (notmore than 2 ppm).
(7) Related Substences-Dissolve 0.10 g of Glycine in 25mL of water and use this solution as the sample solution. Pipet 1 mL of the sample solution, add water to make exactly 50 mL. Pipet 5 mL of this solution, add water to makeexactly 20 mL, and use this solution as the standard solution.Perform the test with these solutions as directed under Thin-layer Chromatography<2.03>. Spot 5mL each of the sample solution and standard solution on a plate of silica gel forthin-layer chromatography. Develop the plate with a mixture of 1-butanol, water and acetic acid (100) (3:1:1) to a distance of about 10 cm, and dry the plate at 80℃ for 30 minutes. Spray evenly a solution of ninhydrin in acetone (1 in 50), andheat at 80℃ for 5 minutes: the spots other than the principal spot from the sample solution are not more intense than the spot from the standard solution.
Loss on Drying <2.41> Not more than 0.30% (1 g, 105℃, 3 hours).
Residue on Ignition <2.44> Not more than 0.10% (1g).
Assay Weigh accurately about 80 mg of Glycine, previously dried, dissolve in 3 mL of formic acid, add 50 mL of acetic acid (100), and titrate <2.50> with 0.1 mol/L perchloric acid VS (potentiometric titration). Perform a blank determi-nation, and make any necessary correction.
Each mL of 0.1 mol/L perchloric acid VS＝7.507 mg of C2H5NO2
Containers and storage Containers-Well-closed containers.