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Impurity reference standards

Bendamustine impurity standards

For Bendamustine, the Zemixal catalogue holds 34 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 2 pharmacopoeial impurities, 7 metabolites or hydroxylated analogues and 2 degradation products.

34reference materials
2pharmacopoeial
7metabolites
2degradants
Bendamustine structure
Parent API

Bendamustine

CAS
16506-27-7
Formula
C16H21Cl2N3O2
MW
358.3 g/mol
Code
ZX-006416

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.

By impurity type

Pharmacopoeial2EP, USP, BP or JP named impurities
Metabolites7Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products

Counts are based on product names. One compound can fall into more than one type.

All Bendamustine reference materials

1–34 of 34 standards
Questions

Bendamustine impurities, answered

What Bendamustine reference materials are available?
The catalogue currently lists 34 compounds for Bendamustine, including 2 pharmacopoeial impurities, 7 metabolites or hydroxylated analogues and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Bendamustine impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Bendamustine impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.
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