N-Nitroso-N-methyl-4-aminobutyric Acid-d3

N-Nitroso-N-methyl-4-aminobutyric Acid-d3 (CAS 1184996-41-5) 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 CCEM500925.

The material is issued against molecular formula C5H7D3N2O3, molecular weight 149.16 g mol⁻¹, physical form described as off-white to yellow oil to low-melting s.

Structural notation: [2H]C(N(N=O)CCCC(O)=O)([2H])[2H]

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 -20 °C ± 5 °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. 2.5 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 CCEM500925 when requesting either document.