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Impurity reference standards

Tafamidis impurity standards

Zemixal lists 17 reference materials related to Tafamidis, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 pharmacopoeial impurity and 4 metabolites or hydroxylated analogues.

17reference materials
1pharmacopoeial
4metabolites
Tafamidis structure
Parent API

Tafamidis

CAS
594839-88-0
Formula
C14H7Cl2NO3
MW
308.1 g/mol
Code
ZX-006838

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. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.

By impurity type

Pharmacopoeial1EP, USP, BP or JP named impurities
Metabolites4Hydroxy, desmethyl and conjugated forms

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

All Tafamidis reference materials

1–17 of 17 standards
Questions

Tafamidis impurities, answered

How many Tafamidis impurity standards does Zemixal list?
The catalogue currently lists 17 compounds for Tafamidis, including 1 pharmacopoeial impurity and 4 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Tafamidis 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 Tafamidis 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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