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Impurity reference standards

Levocarnitine impurity standards

For Levocarnitine, 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 1 metabolite or hydroxylated analogue.

20reference materials
4pharmacopoeial
1isotope labelled
1metabolites

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.

By impurity type

Pharmacopoeial4EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Levocarnitine reference materials

1–20 of 20 standards
Questions

Levocarnitine impurities, answered

What Levocarnitine reference materials are available?
The catalogue currently lists 20 compounds for Levocarnitine, including 4 pharmacopoeial impurities, 1 isotope-labelled standard 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 Levocarnitine 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 Levocarnitine 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 Levocarnitine 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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