Analytical Reference substance
Atorvastatin EP Impurity I
(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 t-butyl ester ;
Product Number: OLY-ATOR-37
CAS Number: 125971-95-1
Lot Number:
Molecular Formula: C40H47FN2O5
Molecular Weight: 654.81
Long Term Storage: 02-08 °C
Appearance:
Melting Point:
Purity By HPLC: NLT 95%
| Sr No. | Test | Results | Date ref. |
|---|---|---|---|
| 1 | 1H NMR | Confirm | Report Attached |
| 2 | Mass | Confirm | Report Attached |
| 3 | HPLC | NLT 95% | Report Attached |
This certificate is valid for two years from the date of Manufacturing Provided the substance is stored under the recommended conditions.
Document data reference:
Prepared by
Dr. Ashish Keche
Head of QA & QC
Dr. Ashish Keche
Head of QA & QC
Reviewed by
Dr. Girish Hatnapure
Head of R& D
Dr. Girish Hatnapure
Head of R& D
Approved by
Dr. Atish Rodge
Managing Director
Dr. Atish Rodge
Managing Director
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