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N-Nitroso-1,2,3,6-tetrahydropyridine

nitrosamine reference standard

CAS55556-92-8
N-Nitroso-1,2,3,6-tetrahydropyridine chemical structure
Cat. no. CWLT600872 Purity >95% HPLC Form Colourless to Light Yellow Liquid

Specifications

Product name
N-Nitroso-1,2,3,6-tetrahydropyridine
CAS number
55556-92-8
Catalogue number
CWLT600872
Molecular formula
C5H8N2O
Molecular weight
112.13
Purity (HPLC)
>95%
Physical form
Colourless to Light Yellow Liquid
Storage
2-8 °C
SMILES
C1C=CCN(N=O)C1
Available pack sizes
Quoted on request
Lead time
In stock
Intended use
Related substances and impurity testing, method development and validation, system suitability, QC release and stability testing; nitrosamine risk assessment and confirmatory testing.

Fields shown as — are not published for this item. They are left blank rather than filled with an estimate.

Description

N-Nitroso-1,2,3,6-tetrahydropyridine (CAS 55556-92-8) 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 CWLT600872.

The material is issued against molecular formula C5H8N2O, molecular weight 112.13 g mol−1, physical form described as colourless to light yellow liquid.

Structural notation: C1C=CCN(N=O)C1

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. Quoted on request. 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 CWLT600872 when requesting either document.

Documentation

Certificate of analysis (per lot)COA-CWLT600872Download
Safety data sheet (SDS)SDS-CWLT600872Download

Documents are issued per lot. The COA you receive describes the lot that ships, not a representative sample.

Regulatory reference

Nitrosamine impurity. Assess against the currently assigned acceptable intake for this specific nitrosamine under ICH M7(R2); the default threshold of toxicological concern does not apply to this class.

References are provided to help you map a standard to a pharmacopoeial method. Confirm the acceptance criteria against your own method before use.

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