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Impurity reference standards

Lansoprazole impurity standards

Zemixal lists 39 reference materials related to Lansoprazole, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 7 pharmacopoeial impurities, 1 isotope-labelled standard, 3 metabolites or hydroxylated analogues and 5 degradation products.

39reference materials
7pharmacopoeial
1isotope labelled
3metabolites
Lansoprazole structure
Parent API

Lansoprazole

CAS
103577-45-3
Formula
C16H14F3N3O2S
MW
369.4 g/mol
Code
ZX-004195

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.

By impurity type

Pharmacopoeial7EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, desmethyl and conjugated forms
Degradants5N-oxides, dimers, lactones and breakdown products

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

All Lansoprazole reference materials

1–39 of 39 standards
S-Lenalidomide
CAS
202271-91-8
Formula
C13H13N3O3
MW
259.26 g/mol
ZX-036702
Questions

Lansoprazole impurities, answered

How many Lansoprazole impurity standards does Zemixal list?
The catalogue currently lists 39 compounds for Lansoprazole, including 7 pharmacopoeial impurities, 1 isotope-labelled standard, 3 metabolites or hydroxylated analogues and 5 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Lansoprazole 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 Lansoprazole 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.
Are isotope-labelled Lansoprazole standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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