Analytical Reference substance
Amorolfine EP Impurity I
(2RS,6SR)-2,6-Dimethyl-4-[(2RS)-(2-methyl-3-(4-(3-methylbutan-2-yl)phenyl)propyl)] morpholine HCl
Product Number: OLYAM0010.0I
CAS Number: 67468-13-7 (base)
Lot Number:
Molecular Formula: C21H35NO (base) C21H36ClNO
Molecular Weight: 317.51 ; 353.97 (Hcl)
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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