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Impurity reference standards

Pantoprazole impurity standards

For Pantoprazole, the Zemixal catalogue holds 36 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 6 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 4 degradation products.

36reference materials
6pharmacopoeial
1metabolites
4degradants
Pantoprazole Sodium structure
Parent API

Pantoprazole Sodium

CAS
138786-67-1
Formula
C16H15F2N3NaO4S
MW
406.4 g/mol
Code
ZX-004204

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Pharmacopoeial6EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants4N-oxides, dimers, lactones and breakdown products

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

All Pantoprazole reference materials

1–36 of 36 standards
Questions

Pantoprazole impurities, answered

What Pantoprazole reference materials are available?
The catalogue currently lists 36 compounds for Pantoprazole, including 6 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 4 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Pantoprazole 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 Pantoprazole 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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