2,2,2-Trifluoro-1-(7-nitro-1,2,4,5-tetrahydro-3H-1,5-methanobenzo[d]azepin-3-yl)ethan-1-one
- CAS
- 230615-53-9
- Formula
- C13H11F3N2O3
- MW
- 300.23 g/mol
ZX-027524
Impurity reference standards
Varenicline impurity standards
Zemixal lists 37 reference materials related to Varenicline, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 3 nitrosamines, 1 metabolite or hydroxylated analogue and 4 degradation products.
37reference materials
3nitrosamines
1metabolites
4degradants
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
Nitrosamines3N-nitroso impurities for ICH M7 work
Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants4N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Varenicline reference materials
1–37 of 37 standards
2,3,4,5-Tetrahydro-1,5-methano-1H-3-benzazepine-7,8-diamine
- CAS
- 808120-35-6
- Formula
- C11H15N3
- MW
- 189.26 g/mol
ZX-023002
2,3,4,5-Tetrahydro-1H-1,5-methano-3-benzazepine Hydrochloride
- CAS
- 230615-52-8
- Formula
- C11H14ClN
- MW
- 195.69 g/mol
ZX-032740
2,3,4,5-Tetrahydro-3-(trifluoroacetyl)-1,5-methano-1H-3-benzazepine
- CAS
- 230615-51-7
- Formula
- C13H12F3NO
- MW
- 255.23 g/mol
ZX-027526
Varenicline Di N-Oxide Hydrochloride Impurity
- CAS
- 1337563-47-9
- Formula
- C13H13N3O2
- MW
- 243.26 g/mol
ZX-006358
Varenicline Mono N-Oxide Hydrochloride Impurity
- CAS
- 2306217-12-7
- Formula
- C13H13N3O
- MW
- 227.26 g/mol
ZX-006360
Questions
Varenicline impurities, answered
How many Varenicline impurity standards does Zemixal list?
The catalogue currently lists 37 compounds for Varenicline, including 3 nitrosamines, 1 metabolite or hydroxylated analogue and 4 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Varenicline 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 Varenicline 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 Varenicline nitrosamine impurities?
Yes. 3 N-nitroso compounds are listed for Varenicline. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.