Ritalin Impurity 2
nitrosamine reference standard
Specifications
- Product name
- Ritalin Impurity 2
- CAS number
- 55557-03-4
- Catalogue number
C4X-28812- Molecular formula
- C14H18N2O3
- Molecular weight
- 262.30
- Purity (HPLC)
- Physical form
- Off-White Solid
- Storage
- 2-8 °C
- SMILES
C1(CCCCN1N=O)C(C(=O)OC)C1C=CC=CC=1- 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
Ritalin Impurity 2 (CAS 55557-03-4) 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 C4X-28812.
The material is issued against molecular formula C14H18N2O3, molecular weight 262.30 g mol−1, physical form described as off-white solid.
Structural notation: C1(CCCCN1N=O)C(C(=O)OC)C1C=CC=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. 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 C4X-28812 when requesting either document.
Documentation
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.