CERTIFICATE OF ANALYSIS
|
PRODUCT NAME: Dabigatran EP Impurity-F
|
|
Date of Mfg: Sample COA
|
RETEST DATE: Sample COA
|
| Catalogue Number |
DAB-016
|
|
| Item/Batch Number |
Sample COA
|
| Quantity |
Sample COA
|
| CAS Number |
NA
|
| Mol. Formula |
C35H43N7O5
|
| Molecular Wt |
641.77
|
| Synonyms |
Chemical Name : Ethyl 3-[[2-[[4-[(E)-N’[[[-(2RS)-heptan-2-yl]oxy]carbonyl]carbamimidoyl]anilino]methyl]-1-methyl-1H-benzimidazole-5-carbonyl]pyridin-2-yl)amino propanoate.
|
| Long Term Storage Condition |
Store in cool and dry place
|
| Handling instruction |
Sample COA
|
| Test |
Results
|
| Appearance |
Off-White to White Solid
|
|
Water content by KF/TGA
|
Sample COA
|
|
% Potency = [100 - (Water content by KF)] X HPLC Purity)] / 100
|
Sample COA
|
| Identification by HNMR |
Sample COA
|
| Identification By IR |
Sample COA
|
| Mass (ESI) |
Sample COA
|
| Solubility |
|
| Purity |
NLT 95% BY HPLC
|
| Analysis Date (Release Date) |
Sample COA
|
| Attachments |
Sample COA
|
| Other Information |
Sample COA
|
|
Note: This material can be used as a referance standard and is for research purpose ONLY and not for human consumption
|
This is Sample COA
|