Glycine, crystals, EMPROVE® EXPERT Ph. Eur., BP, JP, USP, SAFC®
:56-40-6
:
:NH₂CH₂COOH
:MFCD00008131
:75.07 g/mol
:13,04504
:181 °C (1013 hPa)
:83 °C
:1.64 g/cm³ (20 °C)
:Ambient
:200-272-2
- Assay (perchloric acid titration, calculated on dried substance):98.5 - 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