Cinacalcet 226256-56-0 Cinacalcet Hydrochloride
Item |
Specification |
Results |
Description |
White or off-white to yellow crystalline powder |
Conforms |
Identification: |
HNMR: Meet the requirements |
Positive |
Heavy Metal |
NMT 20ppm |
Conforms |
Loss on drying |
NMT0.5% |
0.2% |
Residue on Ignition |
NMT0.2% |
0.05% |
Related substances |
Individual impurity:NMT0.1%Total impurity:NMT1.0% |
0.08%0.50% |
Chiral purity |
Chiral purity: NLT 99.5%Enantiomer: NMT 0.5% |
99.7%0.3% |
Residual solvents |
Ethyl acetate: NMT5000ppmMethanol: NMT3000ppmTHF: NMT5000ppmToluene: NMT890ppmDichloromethane: NMT600ppm |
N.D.N.D.N.D.N.D.N.D.
|
Purity |
NLT 99.0% |
99.5% |
Item |
Specification |
Results |
Description |
White or off-white to yellow crystalline powder |
Conforms |
Identification: |
HNMR: Meet the requirements |
Positive |
Heavy Metal |
NMT 20ppm |
Conforms |
Loss on drying |
NMT0.5% |
0.2% |
Residue on Ignition |
NMT0.2% |
0.05% |
Related substances |
Individual impurity:NMT0.1%Total impurity:NMT1.0% |
0.08%0.50% |
Chiral purity |
Chiral purity: NLT 99.5%Enantiomer: NMT 0.5% |
99.7%0.3% |
Residual solvents |
Ethyl acetate: NMT5000ppmMethanol: NMT3000ppmTHF: NMT5000ppmToluene: NMT890ppmDichloromethane: NMT600ppm |
N.D.N.D.N.D.N.D.N.D.
|
Purity |
NLT 99.0% |
99.5% |
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