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Impurity reference standards

Ranitidine impurity standards

This page brings together 19 Ranitidine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 10 pharmacopoeial impurities and 1 isotope-labelled standard.

19reference materials
10pharmacopoeial
1isotope labelled
Ranitidine structure
Parent API

Ranitidine

CAS
66357-35-5
Formula
C13H22N4O3S
MW
314.41 g/mol
Code
ZX-004207

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Pharmacopoeial10EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards

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

All Ranitidine reference materials

1–19 of 19 standards
Questions

Ranitidine impurities, answered

What Ranitidine reference materials are available?
The catalogue currently lists 19 compounds for Ranitidine, including 10 pharmacopoeial impurities and 1 isotope-labelled standard. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Ranitidine 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 Ranitidine 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 Ranitidine 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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