Product Information |
Product name |
Sitagliptin Phosphate |
CAS No. |
654671-78-0/ 654671-77-9 |
Molecular Formula |
C16H18F6N5O5P |
Molecular Weight |
505.31 |
Quality Standard |
98.5% up by HPLC |
Appearance |
White powder |
COA of Sitagliptin Phosphate |
ITEMS |
STANDARDS |
RESULTS |
Appearance |
White or off-white crystalline powder |
Complies |
Identification |
A. Sitagliptin phosphate in water display discriminate reaction of phosphate.B. HPLC: RRT test solution is similar to RRT reference solution.C. IR: Similar to Reference Substance |
CompliesCompliesComplies |
Related substance |
XG-E ≤0.15% |
N.D. |
XG-F ≤0.15% |
N.D. |
|
XG-G ≤0.15% |
N.D. |
|
XG-H ≤0.15% |
N.D. |
|
XG-K ≤0.15% |
N.D. |
|
XG-L ≤0.15% |
0.01% |
|
XG-M ≤0.15% |
N.D. |
|
XG-N ≤0.15% |
N.D. |
|
Other individual impurity ≤0.10% |
N.D. |
|
Total impurities ≤0.5% |
0.01% |
|
Isomer |
XG-A ≤0.15% |
N.D. |
Water |
3.0%~4.5% |
3.6% |
Residual solvents |
Isopropyl alcohol ≤0.5% |
0.02% |
Methyl tert-bytyl ether ≤0.5% |
N.D. |
|
Acetoacetate ≤0.5% |
N.D. |
|
Dimethylformamide ≤0.088% |
N.D. |
|
Heavy metals |
≤ 10ppm |
Complies |
Assay |
≥98.5% on anhydrous basis |
100.3% |
Conclusion |
Conforms to enterprise standard |
|
Usage |
(All Rights Reserved) (All Rights Reserved)
