Analytical Reference substance

Azelastine EP Impurity B/Azelastine USP RC B

Benzoic Acid 2-(Hexahydro-1-methyl-1H-azepin-4-yl)hydrazide


Product Number: OLY-AZL-B
CAS Number: 117078-69-0 (HCl)
Lot Number:
Molecular Formula: C14H21N3O
Molecular Weight: 247.34

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
Expiry Date: 17-11-2026
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
Reviewed by

Dr. Girish Hatnapure
Head of R& D
Approved by

Dr. Atish Rodge
Managing Director

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