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654671-78-0 Sitagliptin Phosphate C16H15F6N5O.H3PO4
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Product name | Sitagliptin phosphate | |
Appearance | white powder | |
Purity | 99%min | |
CAS No. | 654671-78-0 | |
EINECS No. | 1806241-263-5 | |
MF. | C16H15F6N5O.H3PO4 | |
Grade Standard | Medicine Grade |
Specification:
Certificate of Analysis
Product Name: Sitagliptin Phosphate
CAS No.: 654671-78-0
Batch No. | HF160522 | Quantity | 125.6kgs |
Mfg. Date | May. 22, 2016 | Package | As required |
Rep. Date | May. 25, 2016 | Exp. Date | May. 21, 2018 |
Items | Standards | Results | |
Appearance | White to off-white crystalline powder | Complies | |
Identification | By IR | Complies | |
By HPLC | Complies | ||
Phosphate | Complies | ||
Solubility | Freely soluble in Water | Complies | |
Melting Metals | 202.0ºC~204.0ºC | 202.5ºC~203.8ºC | |
Specific Rotation | -18.0°~-23.0°(C=1,water) | -21.2° | |
Water Content(KF) | ≤ 1.00% | 0.60% | |
Residue on Ignition | ≤ 0.10% | 0.05% | |
Heavy Metals | ≤ 20ppm | Complies | |
Sulphated Ash | ≤ 0.20% | 0.01% | |
Chiral Impurity | ≤ 0.50% | 0.01% | |
Related Substances | Any individual impurity: ≤0.10% | 0.04% | |
Total impurities: ≤0.50% | 0.07% | ||
Assay (HPLC basis on drying) |
98.0%~102.0% | 99.88% | |
Reference Standard | USP39 Standard | ||
Conclusion | The product complied to USP39 standard. | ||
Storage | Preserve in tight,light-resistant containers in a cool place |
Applications of Sitagliptin phosphate
Sitagliptin Phosphate is an oral antihyperglycemic (antidiabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class.
Advantages:
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