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Impurity reference standards

Tadalafil impurity standards

30 characterised compounds linked to Tadalafil are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 7 pharmacopoeial impurities and 3 metabolites or hydroxylated analogues.

30reference materials
7pharmacopoeial
3metabolites
Tadalafil structure
Parent API

Tadalafil

CAS
171596-29-5
Formula
C22H19N3O4
MW
389.4 g/mol
Code
ZX-004148

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

Pharmacopoeial7EP, USP, BP or JP named impurities
Metabolites3Hydroxy, desmethyl and conjugated forms

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

All Tadalafil reference materials

1–30 of 30 standards
Questions

Tadalafil impurities, answered

How many Tadalafil impurity standards does Zemixal list?
The catalogue currently lists 30 compounds for Tadalafil, including 7 pharmacopoeial impurities and 3 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 Tadalafil 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 Tadalafil 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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