Analytical Reference substance
ROXITHROMYCIN EP IMPURITY I
2'-O-[(2-Methoxyethoxy)methyl] roxithromycin; 9-[O-[(2-Methoxyethoxy)methyl]oxime]-2'-O-[(2-methoxyethoxy)methyl]-(9E)-Erythromycin
Product Number: OLY-ROX-I
CAS Number: 425365-66-8
Lot Number: OLYROX0010.0I
Molecular Formula: C45H84N2O17
Molecular Weight: 925.15
Long Term Storage: 2-8
Appearance: Off White Solid
Melting Point:
Purity By HPLC: NLT 98%
| Sr No. | Test | Results | Date ref. |
|---|---|---|---|
| 1 | 1H NMR | Confirm | Report Attached |
| 2 | Mass | Confirm | Report Attached |
| 3 | HPLC | NLT 98% | 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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