Bendamustine N-Desmethyl Impurity Hydrochloride

Polymorphic forms of bendamustine hydrochloride: crystal structure, thermal properties and stability at ambient conditions
By Gaztanaga, Pablo; Baggio, Ricardo; Vega, Daniel Roberto
From Acta Crystallographica, Section B: Structural Science, Crystal Engineering and Materials (2019), 75(6), 933-941
 
Development and validation of a stability-​indicating rp-​hplc method for the determination of bendamustine in raw material and finished product
By Dhananjaya, G.; Naveen, M.; Pathi, P. Janaki; Raghuram, J.; Raju, N. Appala
From World Journal of Pharmaceutical Research (2018), 7(18), 1172-1187
 
Novel validated RP-​HPLC method for bendamustine hydrochloride based on ion-​pair chromatography: application in determining infusion stability and pharmacokinetics
By Singh, Yuvraj; Chandrashekar, Anumandla; Pawar, Vivek K.; Saravanakumar, Veeramuthu; Meher, Jayagopal; Raval, Kavit; Singh, Pankaj; Kumar, R. Dinesh; Chourasia, Manish K.
From Journal of Chromatographic Science (2017), 55(1), 30-39

Stability- indicating novel HPLC method for estimation of Bendamustine in pharmaceutical forms
By Reddy, Gade Srinivas; Reddy, S. L. N. Prasad; Reddy, L. Shiva kumar
From American Journal of PharmTech Research (2016), 6(2), 343-357

Bendamustine N-Desmethyl Impurity Hydrochloride is chemically 4-(5-(Bis(2-chloroethyl)amino)-1H-benzo[d]imidazol-2-yl)butanoic acid Hydrochloride. Bendamustine N-Desmethyl Impurity Hydrochloride is supplied with detailed characterization data compliant with regulatory guideline. Bendamustine N-Desmethyl Impurity Hydrochloride 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 Bendamustine.

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.