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Impurity reference standards

Leucine impurity standards

This page brings together 13 Leucine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 1 nitrosamine and 2 metabolites or hydroxylated analogues.

13reference materials
1nitrosamines
2metabolites

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. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites2Hydroxy, desmethyl and conjugated forms

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

All Leucine reference materials

1–13 of 13 standards
D-tert-Leucine
CAS
26782-71-8
Formula
C6H13NO2
MW
131.17 g/mol
ZX-033060
Questions

Leucine impurities, answered

What Leucine reference materials are available?
The catalogue currently lists 13 compounds for Leucine, including 1 nitrosamine 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 Leucine 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 Leucine 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.
Do you supply Leucine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Leucine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

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