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 acid
, H-Gly-OH
, Glycocoll
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 |
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 |
Learn more
About VWR
Avantor is a vertically integrated, global supplier of discovery-to-delivery solutions for...