Analytical Reference substance
AZITHROMYCIN EP IMPURITY P / USP RC - P (RRT- 0.93) (CONFIRM AND SPIKE WITH EDQM MIXTURE AND USP IMPURITY MIXTURE)
Unknown Impurity (As per pharmacopeia)
Product Number: OLY-AZI-P
CAS Number: N.A.
Lot Number: OLYAZI0010.0P
Molecular Formula: N.A.
Molecular Weight: 763.02
Long Term Storage: 10-15 °C
Appearance:
Melting Point:
Purity By HPLC: 93.01%
| Sr No. | Test | Results | Date ref. |
|---|---|---|---|
| 1 | 1H NMR | Confirm | Report Attached |
| 2 | Mass | Confirm | Report Attached |
| 3 | HPLC | 93.01% | 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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