Trospium Nitroso Impurity
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E-mail: anna@molcoo.com
Product Code: T089004
English Name: Trospium Nitroso Impurity 4
English Alias: (1R,3r,5S)-8-nitroso-8-azabicyclo[3.2.1]octan-3-yl 2-hydroxy-2,2-diphenylacetate
CAS No.：[Not Available]
Molecular Formula: C₂₁H₂₂N₂O₄
Molecular Weight: 366.41
High Purity: HPLC ≥98.0%, confirmed by NMR and HRMS.
Stability: Stable for 12 months at -20℃, with <0.5% degradation in acetonitrile.
Regulatory Compliance: Meets EMA guidelines for nitrosamine-containing impurities.
Impurity Control: Detects nitrosoester impurities in Trospium formulations via LC-MS.
Synthesis Monitoring: Tracks nitroso group transfer during esterification steps.
Safety Studies: Supports toxicological evaluation of nitrosoester derivatives.
This impurity arises from nitrosoation of the azabicyclic alcohol followed by esterification. Nitrosoesters pose higher genotoxic risks, requiring rigorous control.
Detection: UPLC-MS/MS with phenyl-hexyl column; LOD: 0.05 ppm.
Formation Mechanism: Induced by nitrous acid in esterification media; using anhydrous conditions reduces generation by 75%.
Toxicity: Preliminary in vitro studies show mutagenic potential; urgent animal studies prioritized for risk assessment.
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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