Description
Bendamustine hydrochloride is listed in the oncology-focused API portfolio. The page is a technical overview only; clinical, regulatory and commercial status must be established from approved product documentation.
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Oncology API / Pharmaceutical technical profile
Bendamustine hydrochloride
4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid;hydrochloride
Category: Oncology APICAS No.: 3543-75-7Formula: C16H22Cl3N3O2
Swati Industries portfolio01 02 03
Chemical & technical profile
Product nameBendamustine hydrochloride
CategoryOncology API
CAS No.3543-75-7
Molecular formulaC16H22Cl3N3O2
Molecular weight394.7 g/mol
PubChem CID77082
Research & Development
Impurity identification and fate mapping; genotoxic-impurity risk assessment where relevant; robust assay/related-substances methods; solid-state characterization; stability and packaging studies.
Analytical testing
Identity by IR/LC-MS/NMR; assay and related substances by HPLC/UPLC; residual solvents by GC; water content; XRPD/DSC and particle-size testing where specification-relevant.
Verified chemical reference
4-[5-[bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid;hydrochloride
Open PubChem reference ↗Technical overview only; not a validated manufacturing process or a claim of company capability. Confirm chemical form, CAS No., grade and specifications from the approved specification and batch COA.