Product Information

Azelastine EP Impurity B

Catalogue number	AZL-006
Product Name	Azelastine EP Impurity B
Sub Category	Pharma Reference Standard; Pharmaceutical/API Drug Impurities/Metabolites
API	Azelastine
CAS Number	117078-69-0
Alternate CAS Number	110406-94-5 (free base)
HS Code	29339900
Molecular formula	C14H21N3O : HCl
Molecular Weight	247.3 : 36.5 g/mol
Synonyms	Azelastine USP Related Compound B
Chemical Name	N'-[(4RS)-1-methylhexahydro-1H-azepin-4-yl]benzohydrazide hydrochloride
Appearance	Pale Yellow to Dark Yellow
Melting Point	>78°C (dec.)
Storage	Hygroscopic, Refrigerator, under inert atmosphere
Solubility	DMSO (Slightly, Heated, Sonicated), Methanol (Slightly, Heated), Water (Slightly)
Stability	Hygroscopic
Boiling Point	No Data Available
Applications	Azelastine EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Azelastine EP Impurity B can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Azelastine.
Shipping Condition	Ambient
Sample COA Purity	NLT 97%
Inventory Status	Under Development
Quantity
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