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Impurity reference standards

Lurasidone impurity standards

Zemixal lists 60 reference materials related to Lurasidone, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 2 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 1 degradation product.

60reference materials
2pharmacopoeial
1metabolites
1degradants
Lurasidone structure
Parent API

Lurasidone

CAS
367514-87-2
Formula
C28H36N4O2S
MW
492.7 g/mol
Code
ZX-006624

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.

By impurity type

Pharmacopoeial2EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Lurasidone reference materials

1–60 of 60 standards
Noreximide
CAS
6319-06-8
Formula
C9H9NO2
MW
163.17 g/mol
ZX-033782
Questions

Lurasidone impurities, answered

How many Lurasidone impurity standards does Zemixal list?
The catalogue currently lists 60 compounds for Lurasidone, including 2 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Lurasidone 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 Lurasidone 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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