Glycine 99.01-101.0% (by perchloric acid titration), crystals, EMPROVE® EXPERT Ph. Eur., BP, JP, USP, SAFC®

Supplier: EMD MILLIPORE – PCS CA EXCEP

Synonyms: Aminoacetic acidH-Gly-OHGlycocoll

1.00590.5000 1.00590.1000 1.00590.9025 1.00590.5000
CA1.00590.5000CS 3590.46 CAD
EM1.00590.9025 CA1.00590.5000 EM1.00590.1000 EM1.00590.5000
Glycine 99.01-101.0% (by perchloric acid titration), crystals, EMPROVE® EXPERT Ph. Eur., BP, JP, USP, SAFC®
Glycine

Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).


Certifications: Corresponds to Ph. Eur., BP, JP, USP

Formula: NH₂CH₂COOH
MW: 75.07 g/mol
Melting Pt: 233 °C (dec.)
Density: 1.161 g/cm³ (20 °C)
MDL Number: MFCD00008131
CAS Number: 56-40-6
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Specification Test Results

Assay (perchloric acid titration, calculated on dried substance) 99.0 - 101.0 %
Identity (IR-spectrum) passes test
Appearance white to almost white, crystalline powder
Appearance of solution (100 g/l, CO₂-free water) clear and colorless and not more intense in color than reference solution Y₇
pH (50 g/l CO₂-free water) 5.9 - 6.4
Chloride (Cl) ≤ 70 ppm
Sulfate (SO₄) ≤ 65 ppm
Heavy metals (as Pb) ≤ 10 ppm
As (Arsenic) ≤ 2 ppm
Hydrolyzable substances passes test
Related substances (TLC) passes test
Ninhydrin-positive substances (LC) (any ninhydrin-positive impurity) ≤ 0.10 %
Ninhydrin-positive substances (LC) (ammonium (570 nm)) ≤ 0.02 %
Ninhydrin-positive substances (LC) (total impurities) ≤ 1.0 %
Related substances (HPLC) (Impurity B) ≤ 0.10 %
Related substances (HPLC) (Impurity H) ≤ 0.10 %
Related substances (HPLC) (Impurity I) ≤ 0.10 %
Related substances (HPLC) (unspecified impurities) ≤ 0.10 %
Related substances (HPLC) (Sum of all impurities) ≤ 0.2 %
Related compounds (HPLC) (Glycine anhydride) ≤ 0.10 %
Related compounds (HPLC) (Iminodiacetic acid) ≤ 0.10 %
Related compounds (HPLC) (Diglycine) ≤ 0.10 %
Related compounds (HPLC) (Triglycine) ≤ 0.10 %
Related compounds (HPLC) (Hexamethylenetetramine) ≤ 0.10 %
Related compounds (HPLC) (Total impurities) ≤ 1.0 %
Methanol (HS-GC) ≤ 3000 ppm
Other residual solvents (ICH Q3C) excluded by manufacturing process
Loss on drying (105 °C, 2 h) ≤ 0.2 %
Sulfated ash (600 °C) ≤ 0.1 %
Bacterial endotoxins ≤ 2.0 I.U./g
Total aerobic microbial count (TAMC) ≤ 10 CFU/g
Total combined yeasts/moulds count (TYMC) ≤ 10 CFU/g

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