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% |