N-(1-hydroxy-2-methylpropan-2-yl)-N-methylnitrous amide;27646-81-7
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WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
Product Code：B201378
English Name：N-(1-hydroxy-2-methylpropan-2-yl)-N-methylnitrous amide
English Alias：N-(1-hydroxy-2-methylpropan-2-yl)-N-methylnitrous amide
CAS No.：27646-81-7
Molecular Formula：C₅H₁₂N₂O₂
Molecular Weight：132.16
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for nitroso compound impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol-water mixture within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of this nitroso impurity in related API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors nitroso impurity formation during target compound synthesis, reducing generation by >40% by adjusting reaction system pH (e.g., neutral to weakly alkaline) and temperature (≤25℃).
Method Validation：Serves as a standard for developing nitroso impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
Nitroso compounds, as potential genotoxic impurities (GTIs), are commonly found in the synthesis of amine-containing drugs, possibly originating from side reactions between amines and nitrosating agents. The nitrosamide group in this compound has potential carcinogenicity, and its hydroxyl and tert-butyl structures may affect drug metabolic stability and interaction with biological macromolecules. Strict control of genotoxic impurities in pharmaceuticals makes research on this impurity crucial for ensuring drug safety.
Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 5 minutes, with LOD of 0.002 ng/mL for trace analysis of genotoxic impurities.
Formation Mechanism：Formed by reaction of N-methyl-2-methyl-2-propanamine with nitrite under acidic conditions (e.g., pH <3); optimizing nitrosating agent dosage and post-reaction processing inhibits formation.
Safety Evaluation：In vitro Ames test shows potential mutagenicity, and in vivo mouse model tests demonstrate DNA adduct formation in gastric mucosa at a 10 mg/kg dose. Accelerated stability testing is ongoing to systematically study degradation characteristics and mutagenic risks under high temperature and humidity conditions.
NOTE！
We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
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