PRODUCT NAME: Dabigatran Impurity 8
Date of Mfg: Sample COA	RETEST DATE: Sample COA

Catalogue Number	DAB-034
Item/Batch Number	Sample COA
Quantity	Sample COA
CAS Number	429659-01-8
Mol. Formula	C18H20N4O5
Molecular Wt	372.4
IUPAC	Ethyl 3-[[2-[[4-(hexoxycarbonylcarbamoyl)anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate
Synonyms	beta-Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]carbonyl]phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-, ethyl ester
Long Term Storage Condition	2-8°C Refrigerator
Handling instruction	Sample COA

Test	Results
Appearance	White to Almost white powder to crystal
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	Soluble in water
Purity	NLT 99.00%
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