Carfilzomib Impurity 75;13139-15-6

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E-mail: anna@molcoo.com

Product Information

• Product Code：C043075

• English Name：Carfilzomib Impurity 75

• English Alias：(S)-2-((tert-butoxycarbonyl)amino)-4-methylpentanoic acid

• CAS No.：13139-15-6

• Molecular Formula：C??H??NO?

• Molecular Weight：231.29

Advantages

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

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

Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 75 in Carfilzomib API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors impurity formation during Carfilzomib synthesis, reducing generation by >35% by adjusting Boc protection 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).

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 5 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by acylation of (S)-2-amino-4-methylpentanoic acid with di-tert-butyl dicarbonate under alkaline catalyst (e.g., triethylamine); optimizing catalyst dosage and reaction pH inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC?? of 215.6 μM against RPMI 8226 myeloma cells (Carfilzomib IC??=0.8 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under high temperature and humidity 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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