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Impurity reference standards

Amikacin impurity standards

This page brings together 12 Amikacin related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 7 pharmacopoeial impurities and 1 metabolite or hydroxylated analogue.

12reference materials
7pharmacopoeial
1metabolites

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.

By impurity type

Pharmacopoeial7EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Amikacin reference materials

1–12 of 12 standards
Questions

Amikacin impurities, answered

What Amikacin reference materials are available?
The catalogue currently lists 12 compounds for Amikacin, including 7 pharmacopoeial impurities 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 Amikacin 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 Amikacin 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.
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