Impurity reference standards
Arginine impurity standards
For Arginine, the Zemixal catalogue holds 13 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 2 nitrosamines.
13reference materials
2nitrosamines
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. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.
By impurity type
Nitrosamines2N-nitroso impurities for ICH M7 work
Counts are based on product names. One compound can fall into more than one type.
All Arginine reference materials
1–13 of 13 standards
Questions
Arginine impurities, answered
What Arginine reference materials are available?
The catalogue currently lists 13 compounds for Arginine, including 2 nitrosamines. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Arginine 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 Arginine 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 Arginine nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Arginine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.