Apremilast Impurity NEW

Apremilast Impurity;22235-04-7

WhatsAPP: +86 17386083646
E-mail: anna@molcoo.com

Product Information

• Product Code：A017082

• English Name：Apremilast Impurity 82

• English Alias：N-(1,3-dioxo-1,3-dihydroisobenzofuran-5-yl)acetamide

• CAS No.：22235-04-7

• Molecular Formula：C₁₀H₇NO₄

• Molecular Weight：205.17

Advantages

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

• Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in common solvents like methanol and acetonitrile within 6 months.

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 82 in Apremilast API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors impurity formation during Apremilast synthesis, reducing generation by >30% by adjusting acylation temperature (e.g., 50-60℃) 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).

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 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by condensation of phthalic anhydride with acetamide under alkaline conditions (e.g., sodium carbonate/methanol system); optimizing reaction pH and raw material ratio inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 189.3 μM against HaCaT cells (Apremilast IC₅₀=10.8 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

NEW IN STOCK!

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