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211915-06-9 Dabigatran etexilate Pradaxa
Product name | dabigatran etexilate |
Synonyms | n-(2-(4-(n-(hexyloxycarbonyl)amidino)phenylaminomethyl)-1-methyl-1h-benzimidazol-5-ylcarbonyl)-n-(2-pyridyl)-beta-alanine ethyl ester |
CAS No. | 211915-06-9 |
Molecular weight | 627.74 |
Molecular Formula | C34H41N7O5 |
Boiling Point | 447.2 °C at 760 mmHg |
Appearence | White powder |
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 |
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