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Impurity reference standards

Neotame impurity standards

This page brings together 4 Neotame 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 pharmacopoeial impurity.

4reference materials
1pharmacopoeial
Neotame structure
Parent API

Neotame

CAS
165450-17-9
Formula
C20H30N2O5
MW
378.5 g/mol
Code
ZX-004249

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Pharmacopoeial1EP, USP, BP or JP named impurities

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

All Neotame reference materials

Questions

Neotame impurities, answered

What Neotame reference materials are available?
The catalogue currently lists 4 compounds for Neotame, including 1 pharmacopoeial impurity. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Neotame 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 Neotame 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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