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Impurity reference standards

Sulindac impurity standards

This page brings together 6 Sulindac related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 3 pharmacopoeial impurities.

6reference materials
3pharmacopoeial
Sulindac structure
Parent API

Sulindac

CAS
38194-50-2
Formula
C20H17FO3S
MW
356.4 g/mol
Code
ZX-004016

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. 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

Pharmacopoeial3EP, USP, BP or JP named impurities

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

All Sulindac reference materials

Questions

Sulindac impurities, answered

What Sulindac reference materials are available?
The catalogue currently lists 6 compounds for Sulindac, including 3 pharmacopoeial impurities. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Sulindac 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 Sulindac 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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