Impurity reference standards
Palbociclib impurity standards
61 characterised compounds linked to Palbociclib are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 1 nitrosamine, 4 metabolites or hydroxylated analogues and 5 degradation products.
61reference materials
1nitrosamines
4metabolites
5degradants
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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites4Hydroxy, 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 Palbociclib reference materials
1–60 of 61 standards
1-(2-nitropyridin-3-yl)piperazine 2,2,2-trifluoroacetate
- Formula
- C9H12N4O2.C2HF3O2
- MW
- 322.24 g/mol
ZX-011889
1,1'-(2-nitropyridine-3,5-diyl)dipiperazine 2,2,2-trifluoroacetate
- Formula
- C13H20N6O2.C2HF3O2
- MW
- 406.36 g/mol
ZX-011871
2-(3,5-Dichlorophenyl)-1,3-benzoxazole-6-carboxylic Acid (2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol
- CAS
- 827022-35-5
- Formula
- C33H45N7O4
- MW
- 603.8 g/mol
ZX-031708
2-Bromo-3-[2-chloro-4-(cyclopentylamino)-5-pyrimidinyl]-2-butenoic Acid
- CAS
- 2639903-34-5
- Formula
- C13H15BrClN3O2
- MW
- 360.63 g/mol
ZX-031712
6-Acetyl-2-chloro-8-cyclopentyl-5-methylpyrido[2,3-d]pyrimidin-7(8H)-one
- CAS
- 1651214-73-1
- Formula
- C15H16ClN3O2
- MW
- 305.76 g/mol
ZX-012210
6-Acetyl-8-cyclopentyl-5-methyl-2-((3-(piperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one
- CAS
- 2205035-04-5
- Formula
- C24H29N7O2
- MW
- 447.5 g/mol
ZX-026279
6-Bromo-5-(bromomethyl)-2-chloro-8-cyclopentylpyrido[2,3-d]pyrimidin-7(8H)-one
- CAS
- 2324831-15-2
- Formula
- C13H12Br2ClN3O
- MW
- 421.51 g/mol
ZX-031709
Di-tert-butyl 4,4'-(2-nitropyridine-3,5- diyl)bis(piperazine-1-carboxylate)
- Formula
- C23H36N6O6
- MW
- 492.57 g/mol
ZX-012418
di-tert-Butyl 4,4'-(6,6'-((8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidine-2,6-diyl)bis(azanediyl))bis(pyridine-6,3-diyl))bis(piperazine-1-carboxylate)
- CAS
- 2206135-30-8
- Formula
- C41H55N11O5
- MW
- 781.9 g/mol
ZX-031710
Palbociclib Pyridine N-Oxide Hydrochloride Impurity
- CAS
- 2098673-44-8
- Formula
- C24H30ClN7O3
- MW
- 500 g/mol
ZX-006322
Tert-butyl 4-(2-nitropyridin-3-yl)piperazine-1-carboxylate
- CAS
- 1779124-68-3
- Formula
- C14H20N4O4
- MW
- 308.33 g/mol
ZX-012870
Questions
Palbociclib impurities, answered
How many Palbociclib impurity standards does Zemixal list?
The catalogue currently lists 61 compounds for Palbociclib, including 1 nitrosamine, 4 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 Palbociclib 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 Palbociclib 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 Palbociclib nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Palbociclib. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.