Isopropyl 2-(naphthalen-1-yl)acetimidate Hydrochloride
- CAS
- 161983-06-8
- Formula
- C15H18ClNO
- MW
- 263.76 g/mol
ZX-030765
Impurity reference standards
Naphazoline impurity standards
For Naphazoline, the Zemixal catalogue holds 8 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 3 pharmacopoeial impurities and 1 nitrosamine.
8reference materials
3pharmacopoeial
1nitrosamines
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.
By impurity type
Pharmacopoeial3EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Counts are based on product names. One compound can fall into more than one type.
All Naphazoline reference materials
1–8 of 8 standards
Questions
Naphazoline impurities, answered
What Naphazoline reference materials are available?
The catalogue currently lists 8 compounds for Naphazoline, including 3 pharmacopoeial impurities and 1 nitrosamine. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Naphazoline 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 Naphazoline 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 Naphazoline nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Naphazoline. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.