Trospium Nitroso Impurity

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Product Code: T089003
English Name: Trospium Nitroso Impurity 3
English Alias: (1R,3r,5S)-8-nitroso-8-azabicyclo[3.2.1]octan-3-ol
CAS No.:[Not Available]
Molecular Formula: C₇H₁₂N₂O₂
Molecular Weight: 156.18
Structural Confirmation: Characterized by NMR (chiral shift reagents) and HRMS, ≥98.5% purity by HPLC.
Stability: Shelf life of 18 months at -20℃, with <1% degradation in ethanol.
Regulatory Compliance: Supports ICH Q3C for nitrosamine impurity control.
Nitroso Impurity Detection: Quantifies nitrosamines in Trospium via LC-MS/MS, meeting USP nitrosamine limits.
Process Optimization: Monitors nitroso formation during amine oxidation steps.
Method Validation: Validates GC-MS methods for nitrosamine analysis.
This impurity may form from nitrosoation of Trospium's azabicyclic ring, a concern due to potential carcinogenicity of nitrosamines. Regulatory agencies mandate strict control.
Detection: LC-MS/MS with amine-specific column; LOD: 0.01 ppm.
Formation: Catalyzed by nitrite ions under acidic conditions; adding scavengers reduces content by 90%.
Toxicity: In vitro mutagenicity tests (Ames) pending; animal carcinogenicity studies planned.
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 17320513646
E-mail: anna@molcoo.com
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