(2E,4E)-1-Chloro-4-(chloromethyl)-8,8-dimethylnona-2,4-dien-6-yne
- CAS
- 1176744-63-0
- Formula
- C12H16Cl2
- MW
- 231.16 g/mol
ZX-042564
Impurity reference standards
Terbinafine impurity standards
This page brings together 32 Terbinafine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 7 pharmacopoeial impurities, 2 nitrosamines and 1 metabolite or hydroxylated analogue.
32reference materials
7pharmacopoeial
2nitrosamines
1metabolites
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.
By impurity type
Pharmacopoeial7EP, USP, BP or JP named impurities
Nitrosamines2N-nitroso impurities for ICH M7 work
Metabolites1Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Terbinafine reference materials
1–32 of 32 standards
1-(4-(Aminomethyl)naphthalen-1-yl)-N,N-dimethylmethanamine
- CAS
- 2514708-08-6
- Formula
- C14H18N2
- MW
- 214.31 g/mol
ZX-027179
Questions
Terbinafine impurities, answered
What Terbinafine reference materials are available?
The catalogue currently lists 32 compounds for Terbinafine, including 7 pharmacopoeial impurities, 2 nitrosamines and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Terbinafine 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 Terbinafine 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 Terbinafine nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Terbinafine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.