Hebei R&M Healthcare Company Ltd.
Hebei R&M Healthcare Co., Ltd. Benefit to World, Service to Mankind
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Product Details
| items | specification | results |
| description | white or almost white crystalline powder | complies |
| identification |
a) ir spectrum b) by hplc |
complies |
| solubility | soluble in water | complies |
| water | not more than 0.5% | 0.12% |
| residue on ignition | not more than 0.1% | complies |
| specific rotation | -7.3 - -9.3°(c=1, methanol, 25 °c | -8.2° |
| heavy metals | not more than 10ppm | complies |
| related compound a | not more than 0.5% | 0.02% |
| chromatographic purity |
any individual impurity: not more than 0.1% total impurities: not more than 0.5% |
0.02% 0.10% |
|
organic volatile impurities |
thf: not more than 720ppm ethyl acetate: note more than 5000ppm dcm: not more than 600ppm methanol: not more than 3000ppm |
n/a n/a n/a n/a |
| purity (hplc) | nlt 99.0% | 99.85% |
| assay (on anhydrous basis) | 99.0% ~ 101.0% (c10h16n2o4s3.hcl) | 100.31% |
| items | specification | results |
| description | white or almost white crystalline powder | complies |
| identification |
a) ir spectrum b) by hplc |
complies |
| solubility | soluble in water | complies |
| water | not more than 0.5% | 0.12% |
| residue on ignition | not more than 0.1% | complies |
| specific rotation | -7.3 - -9.3°(c=1, methanol, 25 °c | -8.2° |
| heavy metals | not more than 10ppm | complies |
| related compound a | not more than 0.5% | 0.02% |
| chromatographic purity |
any individual impurity: not more than 0.1% total impurities: not more than 0.5% |
0.02% 0.10% |
|
organic volatile impurities |
thf: not more than 720ppm ethyl acetate: note more than 5000ppm dcm: not more than 600ppm methanol: not more than 3000ppm |
n/a n/a n/a n/a |
| purity (hplc) | nlt 99.0% | 99.85% |
| assay (on anhydrous basis) | 99.0% ~ 101.0% (c10h16n2o4s3.hcl) | 100.31% |