| CAS No.: | 70-18-8 |
|---|---|
| Formula: | / |
| EINECS: | / |
|
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| Test Items | Specifications | Results | |
| Appearance | White or almost white, crystalline powder or colourless crystals |
White crystalline powder | |
| Solubility | freely soluble in water, very slightly solublie in ethanol and in | Complies | |
| Identification | S.O.R. | -15.5°~-17.5° | -15.6° |
| Infrared | Conforms to the Reference Spectrum | Conforms to the Reference Spectrum | |
| Appearance of solution | Clear and colourless | Clear and colourless | |
| Specific optical rotation | -15.5°~-17.5° | -15.6° | |
| Related substances: | |||
| - Impurity A (L-cysteinylglycine) | Not more than 0.5% | <0.05% | |
| - Impurity B (Cysteine) | Not more than 0.5% | <0.05% | |
| - Impurity C (L-glutathione oxidised) | Not more than 1.5% | 0.12% | |
| - Impurity D(L-γ-glutamyl-L-cysteine) | Not more than 1.0% | 0.31% | |
| -Impurity E (Product of degradation) | Not more than 0.5% | 0.05% | |
| - Total Impurities | Not more than 2.5% | 0.58% | |
| Chlorides | Maximum 200 ppm | Complied | |
| Sulphates | Maximum 300 ppm | Complied | |
| Ammonium | Maximum 200 ppm | Complied | |
| Iron | Not more than 10 ppm | Complied | |
| Heavy Metals | Not more than 10 ppm | Complied | |
| Loss on drying | Maximum 0.5% | 0.4% | |
| Sulfated ash | Maximum 0.1% | 0.04% | |
| Bacterial Endotoxin | Not more than 0.10EU/mg | Complied | |
| Assay | 98.0% to 101.0% | 99.3% | |
| Conclusion | Complies with the standard of European Pharmacopoeia 10.0 | ||
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