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Impurity reference standards

Dutasteride impurity standards

Zemixal lists 17 reference materials related to Dutasteride, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 6 pharmacopoeial impurities, 2 isotope-labelled standards and 1 metabolite or hydroxylated analogue.

17reference materials
6pharmacopoeial
2isotope labelled
1metabolites
Dutasteride structure
Parent API

Dutasteride

CAS
164656-23-9
Formula
C27H30F6N2O2
MW
528.5 g/mol
Code
ZX-004126

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

Pharmacopoeial6EP, USP, BP or JP named impurities
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Dutasteride reference materials

1–17 of 17 standards
Questions

Dutasteride impurities, answered

How many Dutasteride impurity standards does Zemixal list?
The catalogue currently lists 17 compounds for Dutasteride, including 6 pharmacopoeial impurities, 2 isotope-labelled standards and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Dutasteride 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 Dutasteride 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.
Are isotope-labelled Dutasteride standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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