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Impurity reference standards

Raloxifene impurity standards

For Raloxifene, the Zemixal catalogue holds 22 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 3 pharmacopoeial impurities, 4 metabolites or hydroxylated analogues and 1 degradation product.

22reference materials
3pharmacopoeial
4metabolites
1degradants
Raloxifene structure
Parent API

Raloxifene

CAS
84449-90-1
Formula
C28H27NO4S
MW
473.6 g/mol
Code
ZX-006757

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
Metabolites4Hydroxy, 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 Raloxifene reference materials

1–22 of 22 standards
Questions

Raloxifene impurities, answered

What Raloxifene reference materials are available?
The catalogue currently lists 22 compounds for Raloxifene, including 3 pharmacopoeial impurities, 4 metabolites or hydroxylated analogues 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 Raloxifene 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 Raloxifene 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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