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Vildagliptin KSM or (S)-1-(2-chloroacetyl)pyrrolidine-2-carbonitrile
COA and analytical documents available along with product.
S. No.
Test
Specifications
Result
1
Description
Off- white to light brown color crystalline powder
Light brown colored crystalline powder
2
Solubility
Freely soluble in methylene chloride
Complies
3
Identification by IR
The IR spectrum of the test sample should be similar to that of standard
Sample matches with standard
4
Water by KF (%, w/w)
Not more than 0.5%
0.22%
5
Residue on ignition (% w/w)
0.15%
6
(R)- isomer content by HPLC (%, area)
Not more than 1.0%
0.41%
7
Related substance (By HPLC)
Any other impurity
0.56%
Total impurities
Not more than 2.0%
1.07%
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