Paliperidone Impurity
Product Code：P008081
English Name：Paliperidone Impurity 81
English Alias：3-(2-chloroethyl)-2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-9-yl palmitate
CAS No.：1415488-05-9
Molecular Formula：C₂₇H₄₅ClN₂O₃
Molecular Weight：481.11
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Paliperidone impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.2% in acetonitrile-water solution within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 81 in Paliperidone API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors Impurity 81 formation during Paliperidone synthesis, reducing generation by >50% by adjusting acylation temperature (e.g., 40-50℃) and reaction time.
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.005 ng/mL).
Paliperidone, an atypical antipsychotic, is used for treating schizophrenia. Impurity 81, as a process-related impurity of Paliperidone, may originate from alkylation side reactions of the pyridopyrimidine ring or incomplete palmitic acid esterification during synthesis. Its chloroethyl and palmitate groups may affect drug stability and efficacy. With stricter FDA and EMA requirements for antipsychotic drug impurities, studying Impurity 81 is crucial for ensuring drug quality.
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 impurity analysis.
Formation Mechanism：Formed by reaction of 2-methyl-4-oxopyridopyrimidine derivatives with 2-chloroethyl palmitate under alkaline conditions (e.g., triethylamine catalysis); optimizing catalyst dosage and solvent polarity (e.g., DMF-water system) inhibits side reactions.
WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com
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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