Pentoxifylline Impurity NEW

Pentoxifylline Impurity

Product Information

• Product Code：P060024

• English Name：Pentoxifylline Impurity 24

• English Alias：ethyl 6-methyl-3,4-dihydro-2H-pyran-5-carboxylate

• CAS No.：10226-28-5

• Molecular Formula：C₉H₁₄O₃

• Molecular Weight：170.21

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), IR, and elemental analysis, suitable for Pentoxifylline impurity analysis and quality control.

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.5% in methanol-water solution within 6 months.

Applications

• Quality Control Testing：Used for HPLC and LC-MS detection of Impurity 24 in Pentoxifylline API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors Impurity 24 formation during Pentoxifylline synthesis, reducing generation by >40% by adjusting cyclization temperature (e.g., 50-60℃) and reaction time.

• Method Validation：Serves as a standard for developing impurity detection methods, verifying HPLC resolution (≥2.0) and LOD (0.05 ng/mL).

Background Description

Research Status

• Detection Technology：HPLC-DAD with C18 column (5μm) and methanol-water (30:70) isocratic elution achieves separation within 8 minutes, with LOD of 0.02 ng/mL for routine impurity analysis.

• Formation Mechanism：Formed by reaction of ethyl acetoacetate with methylacrolein under acidic conditions (e.g., acetic acid catalysis); optimizing catalyst dosage and solvent polarity (e.g., ethanol-water system) inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 215.3 μM against HUVEC cells (Pentoxifylline IC₅₀=28.7 μM), with low toxicity but requiring ≤0.1% limit. Long-term stability testing is ongoing to monitor degradation under different pH 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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