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1 Gram |
Negotiable |
Sitagliptin 486460-32-6 C16H15F6N5O
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Item |
Requirements |
Test Results |
Description |
A white or almost white crystalline powder |
white crystalline powder |
High-performance liquid chromatograph HPLC |
The retention time of test sample major peak complies to reference standard |
Almost the same |
IR - Infrared spectrometry |
The retention time of test sample major peak complies to reference standard |
Almost the same |
Water |
≤1.0% |
0.20% |
Residue on ignition |
≤0.1% |
0.02% |
Sulphate |
≤0.02% |
Qualified |
Chloride |
≤ 0.05% |
Qualified |
Related impurity |
|
|
Total impurity |
≤ 1.0% |
0.10% |
Single impurity |
≤ 0.5% |
0.10% |
Chiral impurity |
≤ 0.5% |
0.18% |
Ethyl acetate |
≤ 0.5% |
0.10% |
Heavy metal |
≤ 20ppm |
<10ppm |
Assay |
≥99.0% |
99.5% |
Conclusion |
Meets the Requirements |
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