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Postion:Product Catalog >Phosphonylcholine Impurity
Phosphonylcholine Impurity
  • Phosphonylcholine Impurity
  • Phosphonylcholine Impurity
  • Phosphonylcholine Impurity
  • Phosphonylcholine Impurity
  • Phosphonylcholine Impurity

Phosphonylcholine Impurity NEW

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Package 10mg 50mg 100mg
Min. Order: 10mg
Supply Ability: 1000
Update Time: 2025-06-18

Product Details

Product Name: Phosphonylcholine Impurity CAS No.: 17364-16-8
Min. Order: 10mg Purity: 99%+ HPLC
Supply Ability: 1000 Release date: 2025/06/18

Phosphonylcholine Impurity17364-16-8

Article illustration

Product Information

  • Product Code:P096005

  • English Name:Phosphonylcholine Impurity 5

  • English Alias:(R)-2-hydroxy-3-(palmitoyloxy)propyl (2-(trimethylammonio)ethyl) phosphate

  • CAS No.:17364-16-8

  • Molecular Formula:C??H??NO?P

  • Molecular Weight:495.63

Advantages

  • High-Purity Reference Standard:Confirmed by HPLC (≥99.0%), NMR (1H, 13C, 31P), HRMS, and elemental analysis, suitable for Phosphonylcholine impurity analysis and quality control.

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

Applications

  • Quality Control Testing:Used for UPLC-MS/MS detection of Impurity 5 in Phosphonylcholine API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

  • Process Optimization Research:Monitors impurity formation during Phosphonylcholine synthesis, reducing generation by >30% by adjusting palmitoylation temperature (e.g., 40-50℃) 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

Phosphonylcholine is a class of functional molecules with biomembrane-mimicking structures, commonly used to synthesize pharmaceutical excipients, liposomal carriers, or antithrombotic materials. Its phosphonylcholine group interacts with platelet surface receptors to reduce material coagulation activity. Impurity 5, a process-related impurity in its synthesis, may originate from palmitic acid esterification or phosphorylation side reactions. Its long-chain fatty acid ester and phosphonylcholine group may affect the membrane fusion properties, blood circulation time, and safety of drug carriers. Strict impurity control for pharmaceutical excipients is critical to formulation stability and clinical safety, 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 12 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

  • Formation Mechanism:Formed by esterification of (R)-glycerophosphocholine with palmitoyl chloride under alkaline catalyst (e.g., triethylamine); optimizing catalyst dosage and reaction pH inhibits side reactions.

  • Safety Evaluation:In vitro hemolysis experiments show that this impurity causes 8.7% hemolysis of red blood cells at 100 μM (main drug hemolysis rate <1%). Although less toxic than the main drug, its content requires strict control. Long-term stability testing is ongoing to monitor ester bond hydrolysis under high temperature and humidity conditions.


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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