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Impurity reference standards

Aprepitant impurity standards

Zemixal lists 27 reference materials related to Aprepitant, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 3 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 2 metabolites or hydroxylated analogues and 1 degradation product.

27reference materials
3pharmacopoeial
1nitrosamines
1isotope labelled
Aprepitant structure
Parent API

Aprepitant

CAS
170729-80-3
Formula
C23H21F7N4O3
MW
534.4 g/mol
Code
ZX-006397

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. 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

Pharmacopoeial3EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 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 Aprepitant reference materials

1–27 of 27 standards
Questions

Aprepitant impurities, answered

How many Aprepitant impurity standards does Zemixal list?
The catalogue currently lists 27 compounds for Aprepitant, including 3 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard, 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 Aprepitant 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 Aprepitant 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 Aprepitant nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Aprepitant. 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 Aprepitant 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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