Items | Standards |
Appearance | White or almost white crystalline powder |
Appearance of Solution | Clear and colorless |
(10% w/v in water) | |
Bulk Density | ≥0.40g/ml |
Tapped Density | ≥0.60g/ml |
Mesh Size | 100% thru mesh 80 |
Identification | S.O.R: -15.5°~-17.5° |
| Infrared: Positive |
Related Substances | L-glutathione oxidized ≤1.5% |
| Total impurities ≤2.0% |
Assay (dry basis) | 98.0%~101.0% |
Loss on Drying (3h at 105℃) | ≤0.5% |
Residue on Ignition | ≤0.1% |
Ammonium | ≤200ppm |
Chloride | ≤200ppm |
Sulfate | ≤300ppm |
Iron | ≤10ppm |
Arsenic | ≤1.0ppm |
Cadmium | ≤0.2ppm |
Lead | ≤0.5ppm |
Mercury | ≤0.3ppm |
Heavy Metals | ≤10ppm |
Total Plate Count | ≤1000cfu/g |
Yeast & Mold | ≤100cfu/g |
Coliforms | Negative/1g |
E.Coli | Negative/10g |
Salmonella | Negative/10g |
Staphylococcus Aureus | Negative/10g |
Items | Standards |
Appearance | White or almost white, crystalline powder or colorless crystals |
Solubility | Freely soluble in water, very slightly soluble in ethanol and in methylene chloride |
Identification | S.O.R.:-15.5°~-17.5° |
| Infrared: Conforms to the Reference Spectrum |
Appearance of solution | Clear and colorless |
Specific optical rotation | -15.5°~-17.5° |
Related substances | -Impurity A (L-cysteinylglycine)≤0.5% |
| -Impurity B (Cysteine)≤0.5% |
| -Impurity C (L-glutathione oxidised)≤1.5% |
| -Impurity D (L-γ-glutamyl-L-cysteine)≤1.0% |
| -Impurity E (Product of degradation)≤0.5% |
| Total Impurities≤2.5% |
Chlorides | ≤200ppm |
Sulphates | ≤300ppm |
Ammonium | ≤200ppm |
Iron | ≤10ppm |
Heavy Metals | ≤10ppm |
Loss on Drying | ≤0.5% |
Sulfated ash | ≤0.1% |
Bacterial Endotoxin | ≤0.1EU/mg |
Assay | 98.0% to 101.0% |