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Impurity reference standards

Rabeprazole impurity standards

For Rabeprazole, the Zemixal catalogue holds 37 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 5 pharmacopoeial impurities, 3 metabolites or hydroxylated analogues and 3 degradation products.

37reference materials
5pharmacopoeial
3metabolites
3degradants
Rabeprazole Sodium structure
Parent API

Rabeprazole Sodium

CAS
117976-89-3
Formula
C18H21N3O3S
MW
359.4 g/mol
Code
ZX-004205

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

Pharmacopoeial5EP, USP, BP or JP named impurities
Metabolites3Hydroxy, desmethyl and conjugated forms
Degradants3N-oxides, dimers, lactones and breakdown products

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

All Rabeprazole reference materials

1–37 of 37 standards
Questions

Rabeprazole impurities, answered

What Rabeprazole reference materials are available?
The catalogue currently lists 37 compounds for Rabeprazole, including 5 pharmacopoeial impurities, 3 metabolites or hydroxylated analogues and 3 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Rabeprazole 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 Rabeprazole 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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