- Min.Order :25 Kilogram
- Purity: 99%
- Payment Terms : L/C,D/A,D/P,T/T
Keywords
Sitagliptin Sitagliptin phosphate Sitagliptin base
Quick Details
- Appearance:
- Application:active pharmaceutical ingredient
- PackAge:25kg/drum
- ProductionCapacity:|Metric Ton|Day
- Storage:
- Transportation:as request
Superiority:
1. Pharm grade grade
2. IN STOCK
3. FAST REPLY
QUALIFED ; EFFICIENCY; RESPONSIBLE
Details:
|
Item |
Standard (USP30) |
Results |
|
Appearance |
White or almost white powder |
White powder |
|
Solubility |
Easy to dissolve in the water |
Complies |
|
Identification |
High-performance liquid chromatograph HPLC |
Almost the same |
|
Infrared absorption |
Almost the same |
|
|
Water |
3.0% ~5.0% |
3.9% |
|
Sulphate |
≤0.02% |
＜0.01% |
|
Chloride |
≤0.05% |
＜0.02% |
|
Phosphate |
18.0% ~20.0% |
19.20% |
|
Heavy metals |
≤20ppm |
＜10ppm |
|
Residue on ignition |
≤0.1% |
0.02% |
|
Chiral impurity |
No more than 1.0% |
0.02% |
|
Specific rotation |
-18.0° ~-23.0° （C=1，water） |
-21.3° |
|
Residual solvents |
Isopropanol ≤5000ppm |
90ppm |
|
Methanol ≤ 3000ppm |
99ppm |
|
|
Toluene ≤ 890ppm |
28ppm |
|
|
DMF ≤880ppm |
34ppm |
|
|
Acetonitrile ≤410ppm |
0ppm |
|
|
Any individual impurity |
≤0.5% |
0.06% |
|
Total impurities |
≤1.0% |
0.16% |
|
HPLC assay |
98.0% ~102.0% |
99.8% |
|
Conclusion : This product complies with in-house standard |
||
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