Customization: | Available |
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Type: | Pharmaceutical Intermediates |
Appearance: | Powder |
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Analysis | Specification | Result | Test Method |
Appearance | White to off white powder powder | Complies | Visual |
Appearance of solution (10% w/v in water) |
Clear and colorless | Complies | Visual |
Bulk density(g/ml) | ≥0.3g/ml | 0.33g/ml | USP <616> |
Tapped Density | ≥0.4g/ml | 0.52g/ml | USP <616> |
Substances | Total impurities≤2.0% | 1.3% | GSH USP monograph |
Related | L-glutathine oxidized | ≤ 1.5% | GSH USP monograph |
Identification | S.O.R(- 15.5° ~-17.5°) | - 16. 1° | USP<781S> |
Infrared | Positive | USP< 197K> | |
Loss on drying (3h at 105ºC) | ≤0.5% | 0. 1% | USP39 <731> |
Residue of Ignition | ≤0. 1% | <0. 1% | USP39 <281> |
Assay (dry basis) | 98%- 101. 1% | 99.50% | GSH USP monograph |
Ammonium | ≤200ppm | Complies | GSH USP monograph |
Chloride | ≤200ppm | Complies | USP <241> |
Sulfate | ≤300ppm | Complies | USP <221> |
Iron | ≤ 10ppm | Complies | USP <221> |
Pb | ≤0.5ppm | Complies | ICP-MS |
As | ≤0.5ppm | Complies | ICP-MS |
Hg | ≤0.5ppm | Complies | ICP-MS |
Cd | ≤0.5ppm | Complies | ICP-MS |
Total Plate Count | ≤ 10000cfu/g | N.D | USP39 <61> |
Yeast & Mold | ≤ 100cfu/g | N.D | USP39 <61> |
E.Coli | Negative | Complies | USP39 <62> |
S. aureus | Negative | Complies | USP39 <62> |