Sitagliptin (3R)-3-Amino-1-[3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one CAS: 486460-32-6
Product Name: Sitagliptin
Manufacture Date: 05th,Feb.,2023 Analysis Date: 05th,Feb.,2023 Expiry Date: 04th,Feb.,2025
Storage: Store in cool&dry place, in well-closed containers.
Test Items | Specification | Result | |
Description | white powder | White powder | |
Identification IR | Similar with the Reference Spectrum | Complies | |
Optical Rotation | - 15.5° ~ - 17.5° | - 16.3° | |
Clearity and color of solution | Clear and colourless | Clear and colourless | |
Heavy Metals | Not more than 10ppm | Complies | |
Arsenic | Not more than 1ppm | Complies | |
Sulphates | Not more than 300ppm | Complies | |
Ammonium | Not more than 200ppm | Complies | |
Iron | Not more than 10ppm | Complies | |
Cadmium | Not more than 1ppm | Complies | |
Lead | Not more than 3ppm | Complies | |
Mercury | Not more than 0. 1ppm | Complies | |
Related Substances | Total | Not more than 2.0% | 0.9% |
GSSG | Not more than 1.5% | 0.3% | |
Loss on Drying | Not more than 0.5% | 0.2% | |
Residue on Ignition | Not more than 0. 1% | 0.04% | |
Assay | 98.0% to 101.0% | 99.0% | |
Microbiology |
Total plate count | ≤1000cfu/g | Complies |
Yeast and mold count | ≤100cfu/g | Complies | |
Total coli forms | ≤100cfu/g | Complies | |
E. coli | Absent/10g | Complies | |
S. aureus | Absent/10g | Complies | |
Salmonella | Absent/10g | Complies | |
Conclusion | Enterprise Standard |
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