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Impurity reference standards

Carbamazepine impurity standards

37 characterised compounds linked to Carbamazepine are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 6 pharmacopoeial impurities, 2 nitrosamines, 1 isotope-labelled standard and 5 metabolites or hydroxylated analogues.

37reference materials
6pharmacopoeial
2nitrosamines
1isotope labelled
Carbamazepine structure
Parent API

Carbamazepine

CAS
298-46-4
Formula
C15H12N2O
MW
236.27 g/mol
Code
ZX-004028

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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial6EP, USP, BP or JP named impurities
Nitrosamines2N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites5Hydroxy, desmethyl and conjugated forms

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

All Carbamazepine reference materials

1–37 of 37 standards
Questions

Carbamazepine impurities, answered

How many Carbamazepine impurity standards does Zemixal list?
The catalogue currently lists 37 compounds for Carbamazepine, including 6 pharmacopoeial impurities, 2 nitrosamines, 1 isotope-labelled standard and 5 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 Carbamazepine 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 Carbamazepine 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 Carbamazepine nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Carbamazepine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Carbamazepine 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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