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