Impurity reference standards

Ivacaftor impurity standards

For Ivacaftor, the Zemixal catalogue holds 20 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 isotope-labelled standard and 4 metabolites or hydroxylated analogues.

20reference materials

1isotope labelled

4metabolites

Parent API

Ivacaftor

CAS: 873054-44-5
Formula: C₂₄H₂₈N₂O₃
MW: 392.5 g/mol
Code: ZX-006584

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. 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

Isotope labelled1Deuterated, 13C or 15N internal standards

Metabolites4Hydroxy, desmethyl and conjugated forms

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

All Ivacaftor reference materials

1–20 of 20 standards

(2-Bromo-4,6-ditert-butyl-3-nitrophenyl) methyl carbonate

CAS: 1623021-42-0
Formula: C₁₆H₂₂BrNO₅
MW: 388.25 g/mol

ZX-030078

2-(Aminomethyl)-3,5-di-tert-butylphenol

CAS: 84210-35-5
Formula: C₁₅H₂₅NO
MW: 235.36 g/mol

ZX-030079

2-Amino-4,6-di-tert-butylphenol

CAS: 1643-39-6
Formula: C₁₄H₂₃NO
MW: 221.34 g/mol

ZX-030074

2,4-Di-tert-butyl-5-nitrophenol

CAS: 873055-57-3
Formula: C₁₄H₂₁NO₃
MW: 251.32 g/mol

ZX-030081

2,4-Di-tert-butyl-6-nitrophenol

CAS: 20039-94-5
Formula: C₁₄H₂₁NO₃
MW: 251.32 g/mol

ZX-030080

4-Hydroxyquinoline-3-carboxylic acid

CAS: 34785-11-0
Formula: C₁₀H₇NO₃
MW: 189.17 g/mol

ZX-039296

4-Oxo-1,4-dihydroquinoline-3-carboxylic Acid

CAS: 13721-01-2
Formula: C₁₀H₇NO₃
MW: 189.17 g/mol

ZX-030072

5-Amino-2,4-di-tert-butylphenyl methyl carbonate

CAS: 1182822-31-6
Formula: C₁₆H₂₅NO₃
MW: 279.37 g/mol

ZX-025213

De-Alkylated Ivacaftor

CAS: 873054-39-8
Formula: C₂₀H₂₀N₂O₃
MW: 336.4 g/mol

ZX-030075

Ethyl 4-Hydroxyquinoline-3-Carboxylate

CAS: 52980-28-6
Formula: C₁₂H₁₁NO₃
MW: 217.22 g/mol

ZX-025210

Ethyl 4-hydroxyquinoline-3-carboxylate

CAS: 26892-90-0
Formula: C₁₂H₁₁NO₃
MW: 217.22 g/mol

ZX-040377

Hydroxymethyl Ivacaftor

CAS: 1246213-23-9
Formula: C₂₄H₂₈N₂O₄
MW: 408.5 g/mol

ZX-025211

Ivacaftor

CAS: 873054-44-5
Formula: C₂₄H₂₈N₂O₃
MW: 392.5 g/mol

ZX-006584

Ivacaftor Amine impurity

CAS: 2760759-58-6
Formula: C₂₄H₂₈N₂O₃
MW: 392.5 g/mol

ZX-030076

Ivacaftor Carboxylic Acid

CAS: 1246213-24-0
Formula: C₂₄H₂₆N₂O₅
MW: 422.5 g/mol

ZX-030073

Ivacaftor D18

CAS: 1413431-05-6
Formula: C₂₄H₂₈N₂O₃
MW: 392.5 g/mol

ZX-033650

Ivacaftor Malonate Impurity

CAS: 54535-22-7
Formula: C₁₄H₁₇NO₄
MW: 263.29 g/mol

ZX-030077

Ivacaftor Ortho Isomer

CAS: 873051-52-6
Formula: C₂₄H₂₈N₂O₃
MW: 392.5 g/mol

ZX-021919

Ivacaftor-d9

CAS: 1413431-07-8
Formula: C₂₄H₂₈N₂O₃
MW: 401.5 g/mol

ZX-033651

Phenol, 5-amino-2,4-bis(1,1-dimethylethyl)

CAS: 873055-58-4
Formula: C₁₄H₂₃NO
MW: 221.34 g/mol

ZX-025212

Questions

Ivacaftor impurities, answered

What Ivacaftor reference materials are available?

The catalogue currently lists 20 compounds for Ivacaftor, including 1 isotope-labelled standard 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 Ivacaftor 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 Ivacaftor 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 Ivacaftor standards available?

Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

Nearby APIs in the index

Ivabradine 40 All APIs