Analytical Reference substance
Bisoprolol EP Impurity N ;
(2RS)-1-[4-((2-Ethoxyethoxy)methyl)phenoxy]-3-(isopropylamino)-2-propanol fumarate salt
Product Number: OLY-BI-N
CAS Number: 1346601-75-9 (base)
Lot Number:
Molecular Formula: C17H29NO4 (base);C17H29NO4 . 1/2 (C4H4O4) ;
Molecular Weight: 311.42;369.46
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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