Impurity reference standards
Adagrasib impurity standards
6 characterised compounds linked to Adagrasib are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 1 nitrosamine.
6reference materials
1nitrosamines
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Nitrosamines1N-nitroso impurities for ICH M7 work
Counts are based on product names. One compound can fall into more than one type.
All Adagrasib reference materials
1–6 of 6 standards
(S)-2-(Piperazin-2-yl)acetonitrile dihydrochloride
- CAS
- 2158301-19-8
- Formula
- C6H13Cl2N3
- MW
- 198.09 g/mol
ZX-011855
Questions
Adagrasib impurities, answered
How many Adagrasib impurity standards does Zemixal list?
The catalogue currently lists 6 compounds for Adagrasib, including 1 nitrosamine. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Adagrasib 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 Adagrasib 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 Adagrasib nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Adagrasib. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.