Impurity reference standards
Ribociclib impurity standards
Zemixal lists 35 reference materials related to Ribociclib, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 nitrosamine, 2 isotope-labelled standards, 1 metabolite or hydroxylated analogue and 1 degradation product.
35reference materials
1nitrosamines
2isotope labelled
1metabolites
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. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, 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 Ribociclib reference materials
1–35 of 35 standards
2-((7-Cyclopentyl-6-(dimethylcarbamoyl)-7H-pyrrolo[2,3-d]pyrimidin-2-yl)amino)-5-(piperazin-1-yl)pyridine 1-Oxide
- CAS
- 2069953-39-3
- Formula
- C23H30N8O2
- MW
- 450.5 g/mol
ZX-032173
2-Amino-7-cyclopentyl-N,N-dimethyl-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide
- CAS
- 1331847-17-6
- Formula
- C14H19N5O
- MW
- 273.33 g/mol
ZX-026702
2-Chloro-7-Cyclopentyl-7H-Pyrrolo[2,3-d]Pyrimidine-6-Carbaldehyde
- CAS
- 1211443-55-8
- Formula
- C12H12ClN3O
- MW
- 249.69 g/mol
ZX-031419
2-Chloro-7-cyclopentyl-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic Acid
- CAS
- 1211443-58-1
- Formula
- C12H12ClN3O2
- MW
- 265.69 g/mol
ZX-026701
2-Chloro-7-cyclopentyl-N-methyl-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide
- CAS
- 1211444-14-2
- Formula
- C13H15ClN4O
- MW
- 278.74 g/mol
ZX-032177
5-Bromo-2-chloro-N-cyclopentylpyrimidin-4-amine
- CAS
- 733039-20-8
- Formula
- C9H11BrClN3
- MW
- 276.56 g/mol
ZX-031707
5-Bromo-4-chloro-N-cyclopentylpyrimidin-2-amine
- CAS
- 1823404-28-9
- Formula
- C9H11BrClN3
- MW
- 276.56 g/mol
ZX-022651
7-Cyclopentyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic Acid
- CAS
- 2762182-61-4
- Formula
- C21H25N7O2
- MW
- 407.5 g/mol
ZX-032175
7-Cyclopentyl-N-(hydroxymethyl)-N-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide
- CAS
- 2460734-07-8
- Formula
- C23H30N8O2
- MW
- 450.5 g/mol
ZX-032176
7-Cyclopentyl-N,N-dimethyl-2-((5-(4-tritylpiperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide
- CAS
- 2524428-16-6
- Formula
- C42H44N8O
- MW
- 676.9 g/mol
ZX-026704
tert-Butyl 4-(6-((7-cyclopentyl-6-(dimethylcarbamoyl)-7H-pyrrolo[2,3-d]pyrimidin-2-yl)amino)pyridin-3-yl)piperazine-1-carboxylate
- CAS
- 1374639-78-7
- Formula
- C28H38N8O3
- MW
- 534.7 g/mol
ZX-022650
Questions
Ribociclib impurities, answered
How many Ribociclib impurity standards does Zemixal list?
The catalogue currently lists 35 compounds for Ribociclib, including 1 nitrosamine, 2 isotope-labelled standards, 1 metabolite or hydroxylated analogue 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 Ribociclib 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 Ribociclib 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 Ribociclib nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Ribociclib. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Ribociclib standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.