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Impurity reference standards

Vilazodone impurity standards

This page brings together 22 Vilazodone related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 2 nitrosamines and 4 degradation products.

22reference materials
2nitrosamines
4degradants
Vilazodone structure
Parent API

Vilazodone

CAS
163521-12-8
Formula
C26H27N5O2
MW
441.5 g/mol
Code
ZX-006905

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. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Nitrosamines2N-nitroso impurities for ICH M7 work
Degradants4N-oxides, dimers, lactones and breakdown products

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

All Vilazodone reference materials

1–22 of 22 standards
Questions

Vilazodone impurities, answered

What Vilazodone reference materials are available?
The catalogue currently lists 22 compounds for Vilazodone, including 2 nitrosamines and 4 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Vilazodone 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 Vilazodone 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 Vilazodone nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Vilazodone. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

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