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Impurity reference standards

Roflumilast impurity standards

25 characterised compounds linked to Roflumilast are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 1 isotope-labelled standard, 4 metabolites or hydroxylated analogues and 3 degradation products.

25reference materials
1isotope labelled
4metabolites
3degradants
Roflumilast structure
Parent API

Roflumilast

CAS
162401-32-3
Formula
C17H14Cl2F2N2O3
MW
403.2 g/mol
Code
ZX-006792

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.

By impurity type

Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites4Hydroxy, desmethyl and conjugated forms
Degradants3N-oxides, dimers, lactones and breakdown products

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

All Roflumilast reference materials

1–25 of 25 standards
Questions

Roflumilast impurities, answered

How many Roflumilast impurity standards does Zemixal list?
The catalogue currently lists 25 compounds for Roflumilast, including 1 isotope-labelled standard, 4 metabolites or hydroxylated analogues and 3 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Roflumilast 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 Roflumilast 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.
Are isotope-labelled Roflumilast 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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