CERTIFICATE OF ANALYSIS

PRODUCT NAME: Montelukast Sodium EP Impurity A
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number MON-011
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 190078-45-6
Alternate CAS Number Free Acid: 220927-27-5
Mol. Formula C₃₅H₃₅ClNNaO₃S
Molecular Wt 608.17
Synonyms 1-[[[(1S)-1-[3-[(1E)-2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic Acid Sodium Salt; L 768232; Montelukast EP Impurity A
Long Term Storage Condition Refrigerator, Under Inert Atmosphere
Handling instruction Sample COA
Test Results
Appearance Pale Yellow to Light 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 Chloroform (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