(2R,3R)-4-((4-Chlorophenyl)amino)-2,3-dihydroxy-4-oxobutanoic acid
- CAS
- 17447-35-7
- Formula
- C10H10ClNO5
- MW
- 259.64 g/mol
ZX-039262
Impurity reference standards
Ibrutinib impurity standards
46 characterised compounds linked to Ibrutinib are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 2 nitrosamines, 6 metabolites or hydroxylated analogues and 5 degradation products.
46reference materials
2nitrosamines
6metabolites
5degradants
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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Nitrosamines2N-nitroso impurities for ICH M7 work
Metabolites6Hydroxy, desmethyl and conjugated forms
Degradants5N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Ibrutinib reference materials
1–46 of 46 standards
(R)-3-(4-Phenoxyphenyl)-1-(piperidin-3-yl)-1H-pyrazolo[3,4-d]pyrimidin-4-amine Dihydrochloride
- CAS
- 1701403-10-2
- Formula
- C22H24Cl2N6O
- MW
- 459.4 g/mol
ZX-029868
1,1-Dicyano-2-methoxy-2-(4-phenoxyphenyl)ethene
- CAS
- 330792-69-3
- Formula
- C17H12N2O2
- MW
- 276.29 g/mol
ZX-025045
5-Amino-1-methyl-3-(4-phenoxyphenyl)-1H-pyrazole-4-carbonitrile
- CAS
- 1516569-46-2
- Formula
- C17H14N4O
- MW
- 290.32 g/mol
ZX-029871
Chloro Propanyl Dimer Impurity of Ibrutinib (PCI-7547)
- CAS
- 2031255-23-7
- Formula
- C50H48N12O4
- MW
- 881 g/mol
ZX-004521
N-Desacryloyl N-(3-Acryloyl-propanoyl) Ibrutinib
- CAS
- 2244619-11-0
- Formula
- C28H28N6O4
- MW
- 512.6 g/mol
ZX-029870
Questions
Ibrutinib impurities, answered
How many Ibrutinib impurity standards does Zemixal list?
The catalogue currently lists 46 compounds for Ibrutinib, including 2 nitrosamines, 6 metabolites or hydroxylated analogues and 5 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Ibrutinib 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 Ibrutinib 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.
Do you supply Ibrutinib nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Ibrutinib. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.