Pioglitazone Impurity ;144809-26-7
WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com
Product Code：P062010
English Name：Pioglitazone Impurity 10
English Alias：2-(5-ethylpyridin-2-yl)ethyl methanesulfonate
CAS No.：144809-26-7
Molecular Formula：C₁₀H₁₅NO₃S
Molecular Weight：229.30
High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Pioglitazone impurity analysis and quality control.
Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in common organic solvents (such as methanol, acetonitrile) within 6 months.
Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 10 in Pioglitazone API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).
Process Optimization Research：Monitors Impurity 10 formation during Pioglitazone synthesis, reducing generation by >40% by adjusting sulfonylation temperature (e.g., 0-5℃) and reaction time.
Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).
Pioglitazone, a thiazolidinedione hypoglycemic drug, is used for treating type 2 diabetes. Impurity 10, as a process-related impurity of Pioglitazone, may originate from side products of pyridine ring ethylation or sulfonylation during synthesis. Its methanesulfonate group and ethylpyridine structure may affect drug stability and efficacy. With stricter requirements from global regulatory agencies for hypoglycemic drug impurities, studying Impurity 10 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 4 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.
Formation Mechanism：Formed by reaction of 2-(5-ethylpyridin-2-yl)ethanol with methanesulfonyl chloride under alkaline conditions (e.g., triethylamine/DCM system); optimizing base dosage and reaction solvent polarity inhibits side reactions.
Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 208.3 μM against HepG2 cells (Pioglitazone IC₅₀=18.5 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
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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