Phosphonylcholine Impurity

Min.Order / FOB Price:Get Latest Price

25 Milligram	Negotiable

25 Milligram

Negotiable

Min.Order :25 Milligram
Purity: 95%+ or 98%+

Keywords

Phosphonylcholine Impurity (R)-2-hydroxy-3-(palmitoyloxy)propyl (2-(trimethylammonio)ethyl) phosphate 17364-16-8

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Application:for drug impurity for drug standards,for drug research and development。Drug impurity reference, drug standard, analytical chemistry, standard substance, organic chemical synthesis, chemical custo...
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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.

Our products are mainly drug impurity reference products, drug standards, analytical chemistry, standard substances, organic chemical synthesis, chemical custom synthesis. For impurity localization, quantification, and quality control in drug development processes. Our laboratory area is more than 5000 square meters, we have more than 20 analytical instruments such as HPLC and MS/LC-MS/GC-MS, we also have TGA, IR and other testing instruments. We have the most advanced SFC preparation separation equipment. We can provide a full range of impurity reference/standard products required for drug development. Most of the impurities are synthesized through the process, there are also many items of impurities can not be obtained by synthetic means, need to be obtained through raw materials, intermediates, crude products or side reactions contained in the trace target compounds, Hubei Moke has a professional impurity preparation and separation technology team, equipped with professional SFC preparation and separation equipment. It can carry out efficient and accurate separation of impurities for complex projects, and solve the problem of impurity preparation for customers.

1. We integrate R&D, production and sales. A 5,000-square-meter high-standard bio-intelligent manufacturing base can ensure high quality and fast delivery of products. The professional sales team ensures that you don't need to worry about pre-sales and after-sales.

2. We focus on pharmaceutical standards, pharmaceutical intermediates, pharmaceutical impurity controls, peptide customization, our own laboratory, and undertake customized synthesis projects.

3. We offer products from gram grade to g grade, in addition, some product specifications and packaging can be customized.

4. We have been deeply engaged in the pharmaceutical field for ten years and have rich experience. At present, customers are all over the world, and have been highly recognized and trusted by customers.

5. We can provide a variety of safe ways to transport goods for you to choose.

Details:

Phosphonylcholine Impurity17364-16-8

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.

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