CERTIFICATE OF ANALYSIS

PRODUCT NAME: Atorvastatin EP Impurity I
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number ATV-030
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 125971-95-1
Mol. Formula C40H47FN2O5
Molecular Wt 654.8 g/mol
IUPAC tert-butyl [(4R,6R)-6-[2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxan-4-yl]acetate
Synonyms Atorvastatin Calcium Impurity I (As per 35.1 EP Monograph); 1,1-Dimethylethyl 2-[(4R,6R)-6-[2-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxan-4-yl]acetate; Atorvastatin Acetonide tert-Butyl Ester; (4R,6R)-6-[2-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester; Atorvastatin Ketal Impurity; Atorvastatin Acetonide impurity; tert-Butyl 2-((4R,6R)-6-{2-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl)acetate; Atorvastatin Related Compound I (USP)
Long Term Storage Condition 2-8°C Refrigerator
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
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