CAS No.: | 63-91-2 |
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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-Phenylalanine |
Cas No. | 63-91-2 |
Net Weight | 25kg/drum |
Batch No. | 002-230901A |
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 | -33.5°~ -35.0° | -33.5°~ -35.0° | -33.0°~ -35.5° | -33.5°~ -35.0° |
4 | pH | 5.4~6.0 | 5.4~6.0 | —— | 5.4~6.0 |
5 | Transmittance | ≥98.0% | —— | The solution is clear and not more intensely coloured than reference solution BY6 | ≥98.0% |
6 | Loss on drying | ≤ 0.2% | ≤ 0.3% | ≤0.5% | ≤0.20% |
7 | Residue on ignition | ≤ 0.1% | ≤ 0.4% | ≤ 0.1% | ≤0.10% |
8 | Chloride | ≤ 0.02% | ≤ 0.05% | ≤200 ppm | ≤ 0.020% |
9 | Sulfate | ≤ 0.02% | ≤ 0.03% | ≤300 ppm | ≤ 0.020% |
10 | Ammonium | ≤0.02% | —— | ≤0.02% | ≤0.02% |
11 | Iron | ≤0.001% | ≤ 30ppm | ≤10 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 ≤ 0.5% |
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16 | Endotoxin | < 25EU/g | (Optional) | (Optional) | —— |
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