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Impurity reference standards

Viloxazine impurity standards

For Viloxazine, the Zemixal catalogue holds 7 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 2 nitrosamines and 1 metabolite or hydroxylated analogue.

7reference materials
2nitrosamines
1metabolites
Viloxazine structure
Parent API

Viloxazine

CAS
46817-91-8
Formula
C13H19NO3
MW
237.29 g/mol
Code
ZX-006908

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. 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
Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Viloxazine reference materials

Questions

Viloxazine impurities, answered

What Viloxazine reference materials are available?
The catalogue currently lists 7 compounds for Viloxazine, including 2 nitrosamines and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Viloxazine 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 Viloxazine 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 Viloxazine nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Viloxazine. 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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