Azelastine EP Impurity B

Simultaneous Estimation of Fluticasone propionate, Azelastine Hydrochloride, Phenylethyl alcohol and Benzalkonium chloride by RP-HPLC Method in Nasal spray preparations
K. Lakshmi Narasimha Rao,K. Padmaja Reddy2, K. Sudheer Babu2, K. Soloman Raju2, K. Visweswara Rao2, Jafer Vali Shaik
Int. J. Res. Pharm. Sci. Vol-1, Issue-4, 473-480, 2010
 
A study on forced degradation and validation of stability indicating rp-hplc method for determination of benzalkonium chloride in azelastine hydrochoride pharmaceutical ophthalmic formulation
Pratik kumar gupta, vibha chaturvedi
Asian J Pharm Clin Res, Vol 10, Issue 11, 2017, 374-382
 
Green Analytical Methods for the Separation of Seven Antihistamines: Application in Separation of Azelastine and Related Impurities in Nasal Solution
Lucas Maciel da Costa,1 Heitor Oliveira de Almeida Leite,1 Nájla Mohamad Kassab , 2 and Anil Kumar Singh
Hindawi International Journal of Analytical Chemistry Volume 2019, Article ID 9489723, 11 pages
 
Thermoanalytical Study and Purity Determination of Azelastine Hydrochloride and Emedastine Difumarate
Sawsan A Abdel-Razeq1 , Nahla N Salama2 *, Shimaa Abdel-Atty2 and Naglaa El-Kosy
Pharmaceut Anal Acta 2012, 3:8
 

Azelastine EP Impurity B is chemically N′-[(4RS)-1-methylhexahydro-1H-azepin-4-yl]benzohydrazide hydrochloride (as per EP) ; N'-(1-methylazepan-4-yl)benzohydrazide hydrochloride (as per USP). It is also known as Azelastine USP Related Compound B. 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.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.