Analytical Reference substance
Atorvastatin FXA Impurity
4-{6-(4-Fluorophenyl)-7,8-epoxy-6-hydroxy-8a-isopropyl-7-phenyl-8-(phenylcarbamoyl)hexahydro-2H -pyrrolo[2,1-b][1,3]oxazin-2-yl}-3-hydroxybutanoic acid sodium salt ;
Product Number: OLY-ATOR-40
CAS Number: 1316291-19-6 (sodium salt) ; 873950-17-5 (acid)
Lot Number:
Molecular Formula: C33H34FN2NaO7
Molecular Weight: 612.62
Long Term Storage: 02-08 °C
Appearance: Off White solid
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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