CERTIFICATE OF ANALYSIS

PRODUCT NAME: Linagliptin IHRS
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number LIG-017
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 668270-12-0
Mol. Formula C25H28N8O2
Molecular Wt 472.54 g/mol
IUPAC 8-[(3R)-3-aminopiperidin-1-yl]-7-but-2-ynyl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione
Synonyms Linagliptin (EP/BP) (As per EP Monograph 37.2); 8-[(3R)-3-Amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-1H-purine-2,6-dione; 8-[(3R)-3-Amino-1-piperidinyl]-7-(2-butynyl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-1H-purine-2,6-dione
Long Term Storage Condition 2-8°C Refrigerator
Handling instruction Sample COA
Test Results
Appearance Off-White to Yellowish Orange 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