CERTIFICATE OF ANALYSIS

PRODUCT NAME: Alendronate sodium
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number ALE-006
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 129318-43-0
Alternate CAS Number 66376-36-1(Freebase);260055-05-8(NA Hydrate)
Mol. Formula C4H12NO7P2 : Na
Molecular Wt 248.1 : 23.0 g/mol
IUPAC Sodium hydrogen (4-amino-1-hydroxy-1-phosphonobutyl)phosphonate
Synonyms Alendronate Sodium - API (IP); Sodium hydrogen(4-amino-1-hydroxy-1-phosphonobutyl)phosphonate; (4-Amino-1-hydroxybutylidene)bisphosphonic Acid Monosodium Salt; Phosphonic Acid, (4-amino-1-hydroxybutylidene)bis-, monosodium Salt
Long Term Storage Condition Room temperature (typically 15-30°C)
Handling instruction Sample COA
Test Results
Appearance white to off-white crystalline or amorphous powder
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