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Impurity reference standards

Fludarabine impurity standards

This page brings together 78 Fludarabine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 8 pharmacopoeial impurities, 3 nitrosamines, 5 metabolites or hydroxylated analogues and 1 degradation product.

78reference materials
8pharmacopoeial
3nitrosamines
5metabolites

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Pharmacopoeial8EP, USP, BP or JP named impurities
Nitrosamines3N-nitroso impurities for ICH M7 work
Metabolites5Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Fludarabine reference materials

1–60 of 78 standards
Acetone Azine
CAS
627-70-3
Formula
C6H12N2
MW
112.17 g/mol
ZX-035562
Questions

Fludarabine impurities, answered

What Fludarabine reference materials are available?
The catalogue currently lists 78 compounds for Fludarabine, including 8 pharmacopoeial impurities, 3 nitrosamines, 5 metabolites or hydroxylated analogues and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Fludarabine 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 Fludarabine 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.
Do you supply Fludarabine nitrosamine impurities?
Yes. 3 N-nitroso compounds are listed for Fludarabine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

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