PRODUCT NAME: Dabigatran Impurity 1
Date of Mfg: Sample COA	RETEST DATE: Sample COA

Catalogue Number	DAB-008
Item/Batch Number	Sample COA
Quantity	Sample COA
CAS Number	211914-50-0
Alternate CAS Number	Free base: 429658-95-7; Labeled: 1919877-39-6
Mol. Formula	C₂₇H₃₀ClN₇O₃
Molecular Wt	536.03
Synonyms	N-[[2-[[[4-(Aminoiminomethyl)phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-β-alanine Ethyl Ester Hydrochloride Salt
Long Term Storage Condition	Hygroscopic, -20°C Freezer, Under inert atmosphere
Handling instruction	Sample COA

Test	Results
Appearance	White to Pale Yellow 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	Acetonitrile (Slightly), DMSO (Slightly), Methanol (Slightly), Water (Slightly)
Purity	NLT 98%
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