Palbociclib Impurity 106;223797-47-5

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

• Product Information

• Product Code：P005106

• English Name：Palbociclib Impurity 106

• English Alias：tert-butyl 4-(pyridin-3-yl)piperazine-1-carboxylate

• CAS No.：223797-47-5

• Molecular Formula：C??H??N?O?

• Molecular Weight：263.34

• Advantages

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

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

• Applications

• Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 106 in Palbociclib API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

• Process Optimization Research：Monitors impurity formation during Palbociclib synthesis, reducing generation by >30% by adjusting substitution temperature (e.g., 60-70℃) 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

• Palbociclib, a CDK4/6 inhibitor, is used for treating HR+/HER2- advanced breast cancer by inhibiting the cell cycle. Impurity 106, a process-related impurity in its synthesis, may originate from substitution side reactions of piperazine rings with pyridine or abnormal Boc protection steps. Its pyridine ring, piperazine ring, and tert-butoxycarbonyl may affect drug metabolic stability, lipophilicity, and target binding ability. Strict impurity control for anticancer drugs is critical to drug quality, making research on this impurity essential.

• Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 6 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

• Formation Mechanism：Formed by nucleophilic substitution of 3-chloropyridine with tert-butyl piperazine-1-carboxylate under alkaline catalyst (e.g., potassium carbonate); optimizing catalyst dosage and reaction pH inhibits side reactions.

• Safety Evaluation：In vitro cytotoxicity shows IC?? of 192.6 μM against MCF-7 cells (Palbociclib IC??=10.2 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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