CERTIFICATE OF ANALYSIS

PRODUCT NAME: Afatinib N-Nitroso Impurity 2
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number NIT-068
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number NA
Mol. Formula C23H22ClFN6O4
Molecular Wt 500.9 g/mol
IUPAC (S,E)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(methyl(nitroso)amino)but-2-enamide
Synonyms (S,E)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(methyl(nitroso)amino)but-2-enamide
Long Term Storage Condition –20°C or 4°C
Handling instruction Sample COA
Test Results
Appearance solid (powder or crystalline form)
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 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
This is Sample COA