CERTIFICATE OF ANALYSIS

PRODUCT NAME: Alendronate EP Impurity A
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number ALE-001
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 56-12-2
Mol. Formula C4H9NO2
Molecular Wt 103.1 g/mol
IUPAC 4-Aminobutanoic acid
Synonyms Glutamic Acid - Impurity D (EP/BP) (As per EP Monograph 37.3); Sodium Alendronate Trihydrate- Impurity A (EP/BP); γ-Aminobutyric Acid; 3-Carboxypropylamine; 4-Aminobutyric Acid; Aminalon; GABA; Gaballon; Gamarex; Gammalon; Gammalone;Gammar; Gammasol; Mielogen; Mielomade; Piperidic acid; Piperidinic acid; γ-Aminobutanoic acid; ω-Aminobutyric Acid; Gamma-aminobutyric Acid (USP)
Long Term Storage Condition cool, dry, and well-ventilated place
Handling instruction Sample COA
Test Results
Appearance white or off-white crystalline 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