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Impurity reference standards

Gemcitabine impurity standards

Zemixal lists 18 reference materials related to Gemcitabine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 3 pharmacopoeial impurities and 3 metabolites or hydroxylated analogues.

18reference materials
3pharmacopoeial
3metabolites
Gemcitabine HCl structure
Parent API

Gemcitabine HCl

CAS
122111-03-9
Formula
C9H12ClF2N3O4
MW
299.66 g/mol
Code
ZX-004214

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.

By impurity type

Pharmacopoeial3EP, USP, BP or JP named impurities
Metabolites3Hydroxy, desmethyl and conjugated forms

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

All Gemcitabine reference materials

1–18 of 18 standards
Questions

Gemcitabine impurities, answered

How many Gemcitabine impurity standards does Zemixal list?
The catalogue currently lists 18 compounds for Gemcitabine, including 3 pharmacopoeial impurities and 3 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Gemcitabine 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 Gemcitabine 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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