Bendamustine Related Compounds & Impurities

Bendamustine is a bifunctional alkylating agent with a nitrogen-mustard moiety and benzimidazole ring, used for chronic lymphocytic leukaemia and indolent lymphomas.

Simson Pharma Limited along with its subsidiary offices Simson Pharma Global Ltd. (UK) and Simson Pharma Global LLC (USA) is a trusted manufacturer and supplier of high-quality pharmaceutical reference standards, offering a comprehensive portfolio of Bendamustine reference standards, pharmacopeial and non-pharmacopeial Bendamustine impurities, related compounds, related substances, metabolites, stable isotope-labelled compounds, deuterium labelled compounds and nitrosamine (N-NO) reference standards.

These materials support pharmaceutical research and development, product development, ANDA and DMF submissions, quality control (QC), analytical method development and validation, stability studies, impurity identification, and genotoxic impurity assessment.

Our Bendamustine-related reference standards are thoroughly characterized using advanced analytical techniques and are supplied with comprehensive Certificates of Analysis (COA) and supporting analytical data from our USFDA certified, ISO 17025 and ISO 17034 accredited Lab, to meet global regulatory expectations. EP and USP traceable reference standards can also be provided upon request, subject to availability. Simson is also a provider of EP and USP traceable standards. To ensure consistent quality and reliability, our reference standards are periodically re-tested according to established quality management procedures.

Pharmaceutical Reference Standards / Impurity Standards

Bendamustine
Bendamustine Hydrochloride monohydrate
Monohydroxy Bendamustine Impurity
Bendamustine Related Compound A
Bendamustine Impurity 19
Bendamustine Related Compound H
Bendamustine Deschloro Dimer Impurity
Bendamustine Related Impurity 8
Bendamustine D-Mannitol Ester
Bendamustine Related Compound B
Bendamustine Deschloroethyl Acid Impurity
Bendamustine Ethyl Ester Impurity
Bendamustine Ethyl Ester Impurity Hydrate
Bendamustine Dihydroxy Ester
Bendamustine USP Related Compound G
Bendamustine methyl Ester Impurity
Bendamustine Isopropyl Ester
Bendamustine Isopropyl Ester Impurity
Bendamustine Impurity 13
Bendamustine Impurity 16
Bendamustine Mannitol Ester
Bendamustine Glycerol Ester
Bendamustine Impurity 17
Deschloroethyl Bendamustine Hydrochloride
N-DesmethylBendamustine
4-(5-((2-Chloroethyl)(2-((2,3-dihydroxypropyl)thio)ethyl)amino)-1-methyl-1H-benzo(d)imidazol-2-yl)butanoic acid
Bendamustine Propylene Glycol Ester 1 and 2
Bendamustine Monohydroxy Acid Ethyl Ester
Bendamustine Related Compound E
Bendamustine Dihydroxy
Bendamustine USP Related Compound G
Bendamustine Impurity 8
Bendamustine Nitro Isopropyl Ester Impurity
Bendamustine dinitro impurity
Bendamustine Impurity 7
Bendamustine Amino Isopropyl Ester Impurity
Bendamustine Dihydroxy Isopropyl Ester Impurity
Bendamustine Hydrochloride Nitro Acid Impurity
Bendamustine Hydrochloride Nitro Ethyl Ester Impurity
Bendamustine Intermediate(1-Methyl-5-amino-1H-benzimidazole-2-butanoic acid ethyl ester)
Bendamustine Propylene Glycol Ester 2
Bendamustine Propylene Glycol Ester 1
Isopropyl 3-(5-amino-1-methyl-1H-benzimidazol-2-yl)propanoate
N-Desmethyl Bendamustine hydrochloride
Bendamustine Impurity 26
Bendamustine Impurity 27
Bendamustine Impurity 28
Bendamustine Impurity 29
Bendamustine N-Methyl
Methyl 5-amino-1-methyl-1H-benzimidazole-2-butanoate
Bendamustine PEG Ester
Glutaric Acid-2-methylamino-5-nitromonoanilide
Bendamustine Dideschloroethyl Acid Impurity
Bendamustine Impurity 2
isopropyl4-(5-(2-hydroxyethylamino)-1-methyl-1H-benzo[d]imidazol-2-yl)butanoate
isopropyl4-(5-((2-hydroxyethyl)(methyl)amino)-1-methyl-1H-benzo[d]imidazol-2-yl)butanoate
N-Nitroso Bendamustine
N-Nitroso Bendamustine Impurity
Bendamustine Ether Hydrochloride Impurity
Bendamustine Impurity 24
Bendamustine Ethyl Ester Impurity Hydrochloride
Bendamustine Impurity 6
N-Nitroso N-Desmethyl Bendamustine Impurity
N-Nitroso Bendamustine Impurity 2
Bendamustine Glucose/Fructose Adduct
Bendamustine Impurity 4
Bendamustine Impurity 5
Bendamustine impurity 1
Bendamustine impurity 3
Bendamustine Dimer Impurity 2

Isotope Labelled Compounds

Bendamustine-D8 Hydrochloride
Budesonide Acid D8