Global Manufacturers Of (2R,3S)-3-Phenyl-Isoserine
- High Stereochemical Purity: Critical for taxane intermediate synthesis with guaranteed enantiomeric excess.
- Bulk Procurement: Scalable supply chains offering competitive bulk price structures for industrial demands.
- Regulatory Compliance: Full documentation including COA, MSDS, and detailed manufacturing process records.
The pharmaceutical industry relies heavily on chiral intermediates for the synthesis of complex oncology drugs. Among these, (2R,3S)-3-Phenylisoserine stands out as a critical building block, particularly in the production of Cabazitaxel. Sourcing this compound requires a partner capable of maintaining strict stereochemical integrity while delivering consistent industrial purity levels. As demand for next-generation taxanes grows, identifying a reliable global manufacturer becomes a strategic priority for procurement teams.
This article analyzes the technical specifications, synthesis challenges, and commercial considerations associated with procuring CAS 136561-53-0. We focus on the capabilities required to produce this amino acid derivative at scale without compromising on quality or regulatory standards.
Technical Specifications and Chemical Identity
Understanding the molecular profile of this intermediate is essential for quality control. The compound is chemically defined as (2R,3S)-3-amino-2-hydroxy-3-phenylpropionic acid. Its specific stereochemistry (2R, 3S) is non-negotiable, as incorrect isomers can lead to failed downstream reactions or inactive pharmaceutical ingredients. The molecular formula is C9H11NO3, with a molecular weight of 181.19 g/mol.
Below is a standard technical specification table used for verifying incoming batches during vendor qualification:
| Parameter | Specification |
|---|---|
| Product Name | (2R,3S)-3-Phenylisoserine |
| CAS Number | 136561-53-0 |
| Molecular Formula | C9H11NO3 |
| Molecular Weight | 181.19 g/mol |
| Purity (HPLC) | ≥ 98.0% (Typical ≥ 99.0%) |
| Optical Rotation | Specific rotation must match standard |
| Storage Conditions | 2-8°C, Protected from light |
Synthesis Route and Manufacturing Process
The production of this chiral amino acid involves complex organic transformations. A robust synthesis route typically begins with commercially available precursors such as phenylglycine derivatives or through enzymatic resolution processes. The key challenge lies in establishing the correct stereocenters at the C2 and C3 positions. Manufacturers often employ asymmetric hydrogenation or chiral pool synthesis to ensure the desired configuration.
During the manufacturing process, strict control over reaction temperature, pH, and catalyst loading is required to minimize impurities. Common impurities include the (2S,3R) diastereomer or unreacted starting materials. Advanced purification techniques, such as recrystallization from specific solvent systems, are employed to achieve the required industrial purity. Analytical verification is conducted using chiral HPLC and NMR spectroscopy to confirm the structural identity and enantiomeric excess.
For procurement specialists evaluating potential suppliers, it is vital to request a detailed flowchart of the production method. This ensures that the synthesis route aligns with your internal safety and environmental guidelines. Furthermore, understanding the step count helps in assessing the scalability and potential cost drivers of the material.
Commercial Availability and Bulk Procurement
Market analysis indicates a steady supply of this intermediate, though quality varies significantly between vendors. While some suppliers offer laboratory-scale quantities, few can guarantee consistent tonnage supply for commercial API production. When evaluating the bulk price, buyers must consider the total cost of ownership, which includes purity testing, reprocessing costs, and supply chain reliability.
Competitive pricing structures often depend on order volume and contract duration. Standard packaging options typically include 1kg, 5kg, and 25kg drums, with larger bulk shipments available for established partnerships. It is crucial to verify that the supplier can maintain cold chain logistics if required, as amino acid derivatives can be sensitive to humidity and temperature fluctuations.
For organizations seeking a partner with proven expertise in taxane intermediates, NINGBO INNO PHARMCHEM CO.,LTD. offers a streamlined procurement process. As a premier global manufacturer, they provide comprehensive technical support alongside their chemical supply. When sourcing high-purity (2R,3S)-3-Phenylisoserine, buyers should prioritize vendors who can demonstrate a history of successful regulatory audits and consistent batch-to-batch reproducibility.
Quality Assurance and Regulatory Documentation
In the pharmaceutical sector, documentation is as critical as the chemical itself. A reliable supplier must provide a comprehensive Certificate of Analysis (COA) with every shipment. This document should detail the results of all critical quality attributes, including assay, related substances, residual solvents, and heavy metals. Additionally, Material Safety Data Sheets (MSDS) and stability data are essential for regulatory filings.
Buyers should also inquire about the supplier's change control procedures. Any modification to the manufacturing process or raw material source should be communicated promptly to allow for re-validation. This transparency is key to maintaining compliance with cGMP standards. Suppliers like NINGBO INNO PHARMCHEM CO.,LTD. emphasize traceability, ensuring that every batch can be tracked back to its original raw material inputs.
Key Considerations for Vendor Selection
- Capacity: Can the supplier meet your annual demand without lead time delays?
- Quality Systems: Is the facility ISO certified or compliant with relevant pharmaceutical standards?
- Technical Support: Does the vendor offer assistance with troubleshooting downstream synthesis issues?
- Documentation: Are COA and regulatory support documents provided promptly and accurately?
In conclusion, securing a supply of (2R,3S)-3-phenyl-isoserine requires a balanced approach focusing on both technical capability and commercial reliability. By prioritizing suppliers who offer transparent synthesis route information and robust quality assurance, pharmaceutical companies can mitigate risk and ensure the success of their drug development programs.