Bendamustine Hydrochloride
C16H21Cl2N3O2·HCl
394.72
1H-Benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1-methyl-, monohydrochloride;
4-{5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazole-2-yl}butanoic acid monohydrochloride
[3543-75-7] Bendamustine (free base)
C16H21Cl2N3O2 358.26
[16506-27-7] Monohydrate C16H21Cl2N3O2·HCl·H2O 412.74
[1374784-02-7]
1H-Benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1-methyl-, monohydrochloride;
4-{5-[Bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazole-2-yl}butanoic acid monohydrochloride
[3543-75-7] Bendamustine (free base)
C16H21Cl2N3O2 358.26
[16506-27-7] Monohydrate C16H21Cl2N3O2·HCl·H2O 412.74
[1374784-02-7]
DEFINITION
Bendamustine Hydrochloride is anhydrous or contains one molecule of hydration. The anhydrous form contains NLT 98.0% and NMT 102.0% of bendamustine hydrochloride (C16H21Cl2N3O2·HCl), calculated on the as-is basis. The monohydrate form contains NLT 98.0% and NMT 102.0% of bendamustine hydrochloride (C16H21Cl2N3O2·HCl), calculated on the anhydrous and solvent-free basis.
USP REFERENCE STANDARDS FOR PURCHASE
USP Bendamustine Hydrochloride RSUSP Bendamustine Related Compound A RS
USP Bendamustine Related Compound C RS
USP Bendamustine Related Compound D RS
USP Bendamustine Related Compound E RS
USP Bendamustine Related Compound G RS
USP Bendamustine Related Compound H RS
USP Bendamustine Related Compound I RS