2. Specification of Sitagliptin Phosphate :
|
Item |
Specification |
|
Appearance |
White or whitish solid powder |
|
Melting metals: |
203.0-205.0°C |
|
Specific rotation |
N/A |
|
High-performance liquid chromatograph HPLC |
The retention time of test sample major peak complies to reference standard |
|
IR - Infrared spectrometry |
The retention time of test sample major peak complies to reference standard |
|
Water content |
No more than 1.0% |
|
Residue on ignition |
No more than 0.1% |
|
Related impurity |
Total impurity no more than 1.0% |
|
Any impurity no more than 0.5% |
|
|
Heavy metal |
No more than 20ppm |
|
Assay |
No less than 98.5% |