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Impurity reference standards

Isotretinoin impurity standards

This page brings together 25 Isotretinoin related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 6 pharmacopoeial impurities, 1 isotope-labelled standard and 2 metabolites or hydroxylated analogues.

25reference materials
6pharmacopoeial
1isotope labelled
2metabolites
Isotretinoin structure
Parent API

Isotretinoin

CAS
4759-48-2
Formula
C20H28O2
MW
300.4 g/mol
Code
ZX-006582

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Pharmacopoeial6EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, desmethyl and conjugated forms

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

All Isotretinoin reference materials

1–25 of 25 standards
Questions

Isotretinoin impurities, answered

What Isotretinoin reference materials are available?
The catalogue currently lists 25 compounds for Isotretinoin, including 6 pharmacopoeial impurities, 1 isotope-labelled standard and 2 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 Isotretinoin 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 Isotretinoin 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 Isotretinoin 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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