Carfilzomib Impurity 75;13139-15-6
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E-mail: anna@molcoo.com
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：C₁₁H₂₁NO₄
Molecular Weight：231.29
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.
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).
Carfilzomib, a proteasome inhibitor, is used for treating relapsed or refractory multiple myeloma by selectively inhibiting proteasome activity to induce tumor cell apoptosis. Impurity 75, a process-related impurity in its synthesis, may originate from amino acid condensation reactions or side reactions during Boc protection steps. Its tert-butoxycarbonyl, amino, and methyl branched chain may affect drug solubility, metabolic stability, and efficacy. Strict impurity control for anticancer drugs is critical to drug quality, making research on this impurity essential.
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 IC₅₀ of 215.6 μM against RPMI 8226 myeloma cells (Carfilzomib IC₅₀=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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