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Impurity reference standards

Adapalene impurity standards

For Adapalene, the Zemixal catalogue holds 20 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 4 pharmacopoeial impurities, 1 isotope-labelled standard and 3 metabolites or hydroxylated analogues.

20reference materials
4pharmacopoeial
1isotope labelled
3metabolites
Adapalene structure
Parent API

Adapalene

CAS
106685-40-9
Formula
C28H28O3
MW
412.5 g/mol
Code
ZX-006383

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. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.

By impurity type

Pharmacopoeial4EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, desmethyl and conjugated forms

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

All Adapalene reference materials

1–20 of 20 standards
Questions

Adapalene impurities, answered

What Adapalene reference materials are available?
The catalogue currently lists 20 compounds for Adapalene, including 4 pharmacopoeial impurities, 1 isotope-labelled standard and 3 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Adapalene 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 Adapalene 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 Adapalene 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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