Impurity reference standards

Diethylamine impurity standards

This page brings together 2 Diethylamine related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 1 nitrosamine and 1 isotope-labelled standard.

2reference materials

1nitrosamines

1isotope labelled

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Nitrosamines1N-nitroso impurities for ICH M7 work

Isotope labelled1Deuterated, 13C or 15N internal standards

Counts are based on product names. One compound can fall into more than one type.

All Diethylamine reference materials

1–2 of 2 standards

Diethyl amine D10 Hydrochloride

CAS: 285132-87-8
Formula: C₄H₁₂ClN
MW: 119.66 g/mol

ZX-046409

N-Nitrosodiethylamine-d10

CAS: 1219794-54-3
Formula: C₄H₁₀N₂O
MW: 112.2 g/mol

ZX-035847

Questions

Diethylamine impurities, answered

What Diethylamine reference materials are available?

The catalogue currently lists 2 compounds for Diethylamine, including 1 nitrosamine and 1 isotope-labelled standard. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.

What documents come with a Diethylamine 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 Diethylamine 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 Diethylamine nitrosamine impurities?

Yes. 1 N-nitroso compound is listed for Diethylamine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

Are isotope-labelled Diethylamine standards available?

Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

Nearby APIs in the index

Dienestrol 1 Dienogest 17 Diethylcarbamazine 3 Diethylstibestrol 2 Diethylstilbestrol 2 All APIs