CERTIFICATE OF ANALYSIS

PRODUCT NAME: Sitagliptin EP Impurity A
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number SIT-015
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 823817-58-9
Alternate CAS Number Free Base: 823817-55-6
Mol. Formula C₁₆H₁₈F₆N₅O₅P
Molecular Wt 505.31
IUPAC (3S)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one;phosphoric acid
Synonyms 7-[(3S)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine Phosphate; (S)-Sitagliptin Phosphate; ent-Sitagliptin Phosphate; Sitagliptin EP Impurity A
Long Term Storage Condition Store in cool & dry place.
Handling instruction Sample COA
Test Results
Appearance White 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 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
This is Sample COA