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Postion:Product Catalog >Palbociclib Impurity 107
Palbociclib Impurity 107
  • Palbociclib Impurity 107
  • Palbociclib Impurity 107
  • Palbociclib Impurity 107
  • Palbociclib Impurity 107
  • Palbociclib Impurity 107

Palbociclib Impurity 107 NEW

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Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-07-31

Product Details

Product Name: Palbociclib Impurity 107 CAS No.: 2252258-81-2
Min. Order: 10mg Purity: 99%+ HPLC
Supply Ability: 1000 Release date: 2025/07/31
Molecular formula: C14H21N3O2

Palbociclib Impurity 107;2252258-81-2

=Article illustration

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

Product Information

  • Product Code:P005107

  • English Name:Palbociclib Impurity 107

  • English Alias:tert-butyl 4-(5-nitropyridin-3-yl)piperazine-1-carboxylate

  • CAS No.:2252258-81-2

  • Molecular Formula:C??H??N?O?

  • Molecular Weight:308.33

Advantages

  • High-Purity Guarantee:Confirmed by HPLC (≥99.0%) and verified through multiple methods including NMR (1H, 13C), HRMS, and elemental analysis, providing an accurate and reliable standard for Palbociclib impurity analysis.

  • Good Stability:Stable for 36 months under -20℃ light-protected and sealed storage. The degradation rate is less than 0.3% within 6 months in methanol - water mixture, ensuring stable experimental data and meeting long-term research and quality control requirements.

Applications

  • Quality Control Testing:Used for UPLC-MS/MS detection of Impurity 107 in Palbociclib API and formulations. Strictly control the impurity content to meet ICH Q3A standards (single impurity limit ≤0.1%) and ensure drug quality and safety.

  • Process Optimization Research:Monitor the formation pathway of this impurity during Palbociclib synthesis. By adjusting parameters such as nitro substitution temperature (e.g., 10 - 20℃), reaction time, and reactant ratio, the generation of impurities can be reduced by more than 35%.

  • Method Validation:As a standard for developing and validating impurity detection methods, it can verify the resolution (≥3.0) and limit of detection (0.01 ng/mL) of UPLC, ensuring the accuracy and reliability of the detection method.

Background Description

Palbociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, is widely used in the treatment of HR+/HER2- advanced breast cancer, exerting anti-cancer effects by inhibiting the cell cycle. Impurity 107, a process-related impurity in its synthesis, may originate from the substitution reaction of piperazine rings with nitropyridine or side reactions during Boc protection. Its nitro group, piperazine ring, and tert-butoxycarbonyl may affect the drug's metabolic stability, biological activity, and safety. Given the strict requirements for impurity control of anticancer drugs, research on this impurity is crucial for ensuring drug quality.

Research Status

  • Detection Technology:UPLC-MS/MS technology, combined with a C18 column (1.7μm) and gradient elution with 0.1% formic acid - acetonitrile, achieves impurity separation within 7 minutes, with a detection limit as low as 0.003 ng/mL for high-precision trace impurity detection.

  • Formation Mechanism:Formed by the nucleophilic substitution reaction of 3 - chloro - 5 - nitropyridine with tert-butyl piperazine-1-carboxylate under alkaline catalyst (such as sodium carbonate). Optimizing the dosage of catalyst, reaction pH value and reaction time can effectively inhibit side reactions.

  • Safety Evaluation:In vitro cytotoxicity experiments show that the IC?? of this impurity against MCF - 7 breast cancer cells is 202.5 μM (Palbociclib IC?? = 10.2 μM). Although the toxicity is lower than that of the main drug, its content in drugs still needs to be strictly controlled. Currently, long-term stability tests are being carried out to systematically study its degradation characteristics and potential risks under high temperature, high humidity, and light 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! 






Company Profile Introduction

1. Drug standards and drug impurity reference substances: provide more than 20,000 kinds of spot impurity reference substances, with sufficient supply and same-day delivery. We have a professional R&D team and comprehensive quality control testing to ensure product quality and reliability. 2. Customized synthesis of impurities and new molecules: Quickly respond to the customized needs of CDE impurities, stably supply impurities that have established quality standards, and provide customized synthesis services for new compounds in the research and development of innovative drugs. 3. Preparation and separation of unknown impurities: With a professional impurity preparation and separation technical team and SFC preparation and separation instruments, we can solve the problems of impurity preparation in complex projects. 4. Process development of new drug intermediates: provide the supply of new drugs and new molecular impurities, process optimization services, as well as the screening and impurity analysis of commercialization routes. 5. Peptide synthesis: Provide customized peptide synthesis services, and cover all kinds of degradation impurities and process impurities generated in the research and development of peptide drugs. At the same time, it provides comprehensive structural confirmation data and customized testing services.

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