CERTIFICATE OF ANALYSIS

PRODUCT NAME: Rosuvastatin EP Impurity L
Date of Mfg: Sample COA RETEST DATE: Sample COA
Catalogue Number ROS-009
Item/Batch Number Sample COA
Quantity Sample COA
CAS Number 1024064-70-7 (Calcium)
Alternate CAS Number 1347362-67-7(Sodium Salt), 1347797-73-2(Free acid)
Mol. Formula C22H29FN3O6S
Molecular Wt 482.55
IUPAC (3R,5R)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl (methyl sulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-heptanoic acid calcium salt
Synonyms Rosuvastatin 6,7-Dihydro Impurity,
Long Term Storage Condition Store At 2-8°C
Handling instruction Sample COA
Test Results
Appearance White to Off-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)
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