Intermediate for Cinacalcet
|
Parameter |
Specification Limits |
|
Appearance |
Light Yellow to brown Color Liquid |
|
Solubility |
Soluble in Methanol |
|
Identification by HPLC |
The Retention time of test sample and standard sample shall match. |
|
Water Content |
NMT 1.0% |
|
Enantometric Purity by HPLC |
NLT 99.0% |
|
S-Isomer Content |
NMT 1.0% |
|
Purity by HPLC |
NLT 99.0% |
|
Impurities 1-Acetylnaphthalene Any Individual unknown impurity |
NMT 1.0% NMT 0.5% |