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Impurity reference standards

Testosterone impurity standards

For Testosterone, the Zemixal catalogue holds 61 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 13 pharmacopoeial impurities, 3 isotope-labelled standards and 12 metabolites or hydroxylated analogues.

61reference materials
13pharmacopoeial
3isotope labelled
12metabolites
Testosterone Cypionate structure
Parent API

Testosterone Cypionate

CAS
58-22-0
Formula
C19H28O2
MW
288.4 g/mol
Code
ZX-004150

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

Pharmacopoeial13EP, USP, BP or JP named impurities
Isotope labelled3Deuterated, 13C or 15N internal standards
Metabolites12Hydroxy, desmethyl and conjugated forms

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

All Testosterone reference materials

1–60 of 61 standards
Questions

Testosterone impurities, answered

What Testosterone reference materials are available?
The catalogue currently lists 61 compounds for Testosterone, including 13 pharmacopoeial impurities, 3 isotope-labelled standards and 12 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 Testosterone 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 Testosterone 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 Testosterone standards available?
Yes. 3 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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