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Impurity reference standards

Aripiprazole impurity standards

Zemixal lists 54 reference materials related to Aripiprazole, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 7 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 5 metabolites or hydroxylated analogues and 1 degradation product.

54reference materials
7pharmacopoeial
1nitrosamines
1isotope labelled
Aripiprazole structure
Parent API

Aripiprazole

CAS
129722-12-9
Formula
C23H27Cl2N3O2
MW
448.4 g/mol
Code
ZX-004022

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial7EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites5Hydroxy, 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 Aripiprazole reference materials

1–54 of 54 standards
Questions

Aripiprazole impurities, answered

How many Aripiprazole impurity standards does Zemixal list?
The catalogue currently lists 54 compounds for Aripiprazole, including 7 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 5 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 Aripiprazole 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 Aripiprazole 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 Aripiprazole nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Aripiprazole. 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 Aripiprazole 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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