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Impurity reference standards

Lysine impurity standards

Zemixal lists 26 reference materials related to Lysine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 pharmacopoeial impurity and 1 metabolite or hydroxylated analogue.

26reference materials
1pharmacopoeial
1metabolites
Lysine Hydrochloride structure
Parent API

Lysine Hydrochloride

CAS
657-27-2
Formula
C6H15ClN2O2
MW
182.65 g/mol
Code
ZX-006626

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

Pharmacopoeial1EP, 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 Lysine reference materials

1–26 of 26 standards
D-Homoarginine
CAS
110798-13-5
Formula
C7H16N4O2
MW
188.23 g/mol
ZX-039550
Questions

Lysine impurities, answered

How many Lysine impurity standards does Zemixal list?
The catalogue currently lists 26 compounds for Lysine, including 1 pharmacopoeial impurity 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 Lysine 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 Lysine 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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