1-Nitroso-2,3,4,5-tetrahydro-1H-benzo[b]azepine
- CAS
- 313667-22-0
- Formula
- C10H12N2O
- MW
- 176.21 g/mol
ZX-047917
Impurity reference standards
Nitroso impurity standards
19 characterised compounds linked to Nitroso are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 14 nitrosamines and 2 metabolites or hydroxylated analogues.
19reference materials
14nitrosamines
2metabolites
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. 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
Nitrosamines14N-nitroso impurities for ICH M7 work
Metabolites2Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Nitroso reference materials
1–19 of 19 standards
Questions
Nitroso impurities, answered
How many Nitroso impurity standards does Zemixal list?
The catalogue currently lists 19 compounds for Nitroso, including 14 nitrosamines and 2 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 Nitroso 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 Nitroso 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 Nitroso nitrosamine impurities?
Yes. 14 N-nitroso compounds are listed for Nitroso. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.