Paliperidone Impurity NEW

Paliperidone Impurity

Product Information

• Product Code：P008080

• English Name：Paliperidone Impurity 80

• English Alias：3-(2-chloroethyl)-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one

• CAS No.：41078-70-0

• Molecular Formula：C₁₁H₁₁ClN₂O

• Molecular Weight：222.67

Advantages

• 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 <0.1% in acetonitrile-water solution within 6 months.

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 80 in Paliperidone API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors Impurity 80 formation during Paliperidone synthesis, reducing generation by >50% by adjusting cyclization temperature (e.g., 60-70℃) 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).

Background Description

Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 3 minutes, with LOD of 0.002 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by reaction of 2-methylpyridopyrimidinone with 2-chloroethyl chloride under alkaline conditions (e.g., sodium carbonate catalysis); optimizing the reaction solvent system (e.g., using DMF instead of ethanol) inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 156.7 μM against SH-SY5Y cells (Paliperidone IC₅₀=8.2 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under different humidity, light, and temperature conditions.

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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The Molcoo Laboratory added drug impurity reference standards, including Baricitinib, Piperazine, Benzylpenicillin, Tranilast and multiple N-Nitroso drug impurities! Now available for immediate delivery!