CERTIFICATE OF ANALYSIS

PRODUCT NAME: Alectinib Dimer Impurity
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number ALT-003
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number NA
Mol. Formula C51H51N7O2
Molecular Wt 794.0 g/mol
IUPAC 8-(4-(4-(3-Cyano-9-ethyl-6,6-dimethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazol-8-yl)piperazin-1-yl)piperidin-1-yl)-9-ethyl-6,6-dimethyl-11-oxo-6,11-dih
Synonyms Alectinib Hydrochloride - Impurity B (EP/BP) (As per EP Monograph 37.3); Alectinib dimer; 8-{4-[4-(3-Cyano-9-ethyl-6,6-dimethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazol-8-yl)piperazin-1-yl]piperidin-1-yl}-9-ethyl-6,6-dimethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile (As per USP Commenting Opening 51(1))
Long Term Storage Condition -20°C
Handling instruction Sample COA
Test Results
Appearance fine, crystalline 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 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