Impurity reference standards

Roxatidine impurity standards

This page brings together 4 Roxatidine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 1 nitrosamine and 2 metabolites or hydroxylated analogues.

4reference materials

1nitrosamines

2metabolites

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. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Nitrosamines1N-nitroso impurities for ICH M7 work

Metabolites2Hydroxy, desmethyl and conjugated forms

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

All Roxatidine reference materials

1–4 of 4 standards

1-(3-Hydroxybenzyl)piperidine

CAS: 73279-04-6
Formula: C₁₂H₁₇NO
MW: 191.27 g/mol

ZX-043952

2-(2-Hydroxyacetoxy)acetic Acid

CAS: 30450-85-2
Formula: C₄H₆O₅
MW: 134.09 g/mol

ZX-046061

3-(Nitrosoamino)benzaldehyde

CAS: 876497-65-3
Formula: C₇H₆N₂O₂
MW: 150.13 g/mol

ZX-006090

Roxatidine acetate hydrochloride

CAS: 93793-83-0
Formula: C₁₉H₂₉ClN₂O₄
MW: 384.9 g/mol

ZX-044590

Questions

Roxatidine impurities, answered

What Roxatidine reference materials are available?

The catalogue currently lists 4 compounds for Roxatidine, including 1 nitrosamine and 2 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 Roxatidine 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 Roxatidine 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.

Do you supply Roxatidine nitrosamine impurities?

Yes. 1 N-nitroso compound is listed for Roxatidine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

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