CAS No.: | 657-27-2 |
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Type: | Pharmaceutical Intermediates |
Appearance: | Powder |
Quality: | Technical |
Colour: | White |
Color: | White |
Samples: |
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Customization: |
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Name | L-Lysine HCL |
Cas No. | 657-27-2 |
Net Weight | 25kg/drum |
Batch No. | 007-231001A |
SI. NO. | Items | CP2020 | USP2023 | EP10.0 | AJI92 |
1 | Assay | ≥98.5% | 98.5%~ 101.5 % | 98.5%~ 101.0 % | 99.0%~ 100.5% |
2 | Identification | The IR spectrum conforms to that of reference spectrum | The IR spectrum conforms to that of Reference Standard | The IR spectrum conforms to that of Reference Standard | The IR spectrum conforms to that of Reference Standard |
3 | Specific rotation | +20.4°~ +21.5° | +20.4°~ +21.4° | +21.0°~ +22.5° | +20.7°~ +21.5° |
4 | pH | 5.0~6.0 | —— | —— | 5.0~6.0 |
5 | Transmittance | ≥98.0% | —— | The solution is clear and not more intensely coloured than reference solution B7 or GY7 | ≥98.0% |
6 | Loss on drying | ≤ 0.4% | ≤ 0.4% | ≤0.5% | ≤0.40% |
7 | Residue on ignition | ≤ 0.1% | ≤ 0.1% | ≤ 0.1% | ≤0.10% |
8 | Content of chloride | 19.0%~19.6% | 19.0%~19.6% | Conforms | 19.12%~19.51% |
9 | Sulfate | ≤ 0.02% | ≤ 0.03% | ≤300 ppm | ≤ 0.020% |
10 | Ammonium | ≤0.02% | —— | ≤0.02% | ≤0.02% |
11 | Iron | ≤0.003% | ≤ 30ppm | ≤30 ppm | ≤10 ppm |
12 | Heavy metals | ≤10 ppm | —— | —— | ≤10 ppm |
13 | Arsenic | ≤0.0001% | —— | —— | ≤1ppm |
14 | Other amino acids | ≤ 0.5% | Individual impurity ≤ 0.5% Total impurities ≤ 2.0% |
—— | Conforms |
15 | Ninhydrin-positive substances | —— | —— | Any ninhydrin-positive substance:for each impurity ≤ 0.2% Total ≤ 1.0% |
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16 | Endotoxin | < 10EU/g | (Optional) | (Optional) | —— |
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