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Impurity reference standards

Nizatidine impurity standards

This page brings together 18 Nizatidine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 11 pharmacopoeial impurities, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue.

18reference materials
11pharmacopoeial
1isotope labelled
1metabolites
Nizatidine structure
Parent API

Nizatidine

CAS
76963-41-2
Formula
C12H21N5O2S2
MW
331.5 g/mol
Code
ZX-006688

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.

By impurity type

Pharmacopoeial11EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Nizatidine reference materials

1–18 of 18 standards
Questions

Nizatidine impurities, answered

What Nizatidine reference materials are available?
The catalogue currently lists 18 compounds for Nizatidine, including 11 pharmacopoeial impurities, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Nizatidine 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 Nizatidine 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 Nizatidine 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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