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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% |