Complaint
Product Name:Vildagliptin
Description | White powder | Complies |
Identification | IR | Complies |
| HPLC | Complies |
Heavy metal | ≤10ppm | 5ppm |
Pb | ≤3ppm | 1.5ppm |
Hg | ≤0.1ppm | 0.05ppm |
Cd | ≤1ppm | 0.2ppm |
Loss on drying | ≤0.5% | 0.12 |
Residue on lgnition | ≤0.1% | 0.03 |
Single impurity | ≤0.5% | 0.12 |
Total impurity | ≤1.0% | 0.29 |
Total bacteria | ≤1000cfu/g | <1000 |
Yeast and Mould | ≤100 cfu/g | <000 |
E.coli/25g | Absent | Absent |
Salmonella/25g | Absent | Absent |
Assay | ≥99.0% | 99.4% |
Conclusion | Conforms with USP/EP standards | |
