N-Nitrosodiphenylamine

N-Nitrosodiphenylamine (CAS 86-30-6) is supplied by ImpurityLab as a nitrosamine standard. Nitrosamines are assessed outside the default ICH M7 threshold of toxicological concern and carry a compound-specific acceptable intake. Catalogue number CWLT600215.

The material is issued against molecular formula C12H10N2O, molecular weight 198.22 g mol⁻¹, physical form described as light yellow to amber to dark green powd.

Structural notation: C1C=CC(N(N=O)C2C=CC=CC=2)=CC=1

Nitrosamines are a cohort of concern. The ICH M7 default threshold of toxicological concern of 1.5 µg per day does not apply, and an acceptable intake is assigned for the individual nitrosamine from its own potency data. Converting that intake into a specification in the drug substance requires the maximum daily dose, which usually drives the working concentration well below one part per million.

Because the concentrations involved are low, methods for this class depend on a matched isotope-labelled internal standard and on blank control as much as on chromatographic separation. Where a labelled analogue of this compound is available it is listed in the same category.

Storage. Store at 2-8 °C. Allow the container to reach room temperature before opening so that moisture does not condense onto the material. Record the date of first opening on the label.

Pack sizes. 250 mg. Non-standard quantities are quoted on request, normally within two working days.

Documentation. Each lot is released with a certificate of analysis that states the assay method, the water content and the form as supplied. The safety data sheet is available with the same lot number. Quote catalogue number CWLT600215 when requesting either document.