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Impurity reference standards

Cariprazine impurity standards

37 characterised compounds linked to Cariprazine are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 1 nitrosamine, 3 isotope-labelled standards, 2 metabolites or hydroxylated analogues and 1 degradation product.

37reference materials
1nitrosamines
3isotope labelled
2metabolites
Cariprazine structure
Parent API

Cariprazine

CAS
839712-12-8
Formula
C21H32Cl2N4O
MW
427.4 g/mol
Code
ZX-006453

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

Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled3Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Cariprazine reference materials

1–37 of 37 standards
Questions

Cariprazine impurities, answered

How many Cariprazine impurity standards does Zemixal list?
The catalogue currently lists 37 compounds for Cariprazine, including 1 nitrosamine, 3 isotope-labelled standards, 2 metabolites or hydroxylated analogues and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Cariprazine 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 Cariprazine 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 Cariprazine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Cariprazine. 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 Cariprazine standards available?
Yes. 3 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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