Industrial Purity Specifications For (R)-(-)-3-Quinuclidinol
- [Enantiomeric Precision]: Critical optical rotation metrics (-44.5°) and chiral HPLC methods ensure strict stereochemical control.
- [Tonnage Stability]: Factory-direct logistics support scalable production from pilot batches to multi-ton supply chains.
- [GMP Alignment]: Comprehensive documentation packages including batch-specific COAs and SDS for regulatory audits.
In the pharmaceutical landscape, the demand for high-fidelity chiral intermediates is paramount. (3R)-1-Azabicyclo[2.2.2]octan-3-ol, commonly known as (R)-(-)-3-Quinuclidinol (CAS: 25333-42-0), serves as a critical building block for neuroactive agents and antimuscarinic drugs such as Solifenacin. Achieving consistent industrial purity requires rigorous control over the synthesis route and downstream purification processes. This technical overview details the specifications required for process-scale adoption, ensuring batch-to-batch consistency for commercial grade applications.
Chemical Integrity and Analytical Verification
For process chemists and R&D teams, the primary challenge lies in maintaining enantiomeric excess while minimizing structural impurities. The manufacturing process typically involves the reduction of quinuclidinone derivatives or resolution of racemic mixtures. Regardless of the pathway, the final crystalline powder must meet strict physical constants. The melting point range of 217-224 °C and specific optical rotation of -44.5 º (c=3, 1N HCl) are non-negotiable indicators of identity and purity.
Analytical verification should employ chiral HPLC or GC methods to detect trace enantiomers. Impurity profiles must be documented to ppm levels, particularly for residual solvents and heavy metals. When evaluating stereoisomers within this chemical family, such as when sourcing high-purity dl-3-Quinuclidinol for comparative analysis, buyers should prioritize suppliers who provide full impurity chromatograms alongside standard COA data. This level of transparency is essential for validating the manufacturing process and ensuring compatibility with downstream coupling reactions.
Technical Specifications Table
| Parameter | Specification | Test Method |
|---|---|---|
| CAS Number | 25333-42-0 | N/A |
| Molecular Formula | C7H13NO | Elemental Analysis |
| Molecular Weight | 127.18 g/mol | MS |
| Appearance | White to faintly beige Crystalline Powder | Visual |
| Melting Point | 217-224 °C | DSC / Capillary |
| Optical Rotation | -44.5 º (c=3, 1N HCl) | Polarimetry |
| Assay (Purity) | ≥ 98.0% (Commercial Grade) | HPLC / GC |
| Water Solubility | 100 g/100 mL | Gravimetric |
Procurement and Supply Chain Stability
For procurement officers, securing a reliable global manufacturer is critical to mitigating supply chain risks. Market data indicates significant price volatility on gram-scale quantities, but tonnage quantities offer stabilized bulk price structures. Sourcing directly from the factory eliminates intermediary markups and ensures traceability. A robust supplier will maintain inventory buffers to accommodate sudden scale-up demands without compromising lead times.
Verification of the COA is the cornerstone of quality assurance. Each batch must be accompanied by a certificate that matches the physical parameters listed above. NINGBO INNO PHARMCHEM CO.,LTD. operates as a premier partner in this sector, offering verified production capacity and strict quality control protocols that align with international pharmaceutical standards. This ensures that the material received matches the technical data sheet exactly, reducing the risk of production delays due to out-of-spec raw materials.
Regulatory Compliance and Commercial Viability
Executives must consider the regulatory landscape when integrating new intermediates into the production pipeline. Compliance with REACH and TSCA regulations is mandatory for market access in Europe and North America. Furthermore, the handling of this compound requires adherence to specific safety statements, including the use of protective clothing and ventilation due to potential skin and eye irritation.
Scalability is the final metric for commercial viability. The transition from laboratory synthesis to industrial production must not alter the impurity profile. By partnering with an established entity like NINGBO INNO PHARMCHEM CO.,LTD., organizations gain access to scalable reaction pathways that maintain process-scale purity. This strategic alignment supports long-term commercial viability, ensuring that regulatory filings remain valid throughout the product lifecycle.
To ensure your project meets all technical and regulatory requirements, we invite you to contact our technical sales team for a batch-specific COA, SDS, or bulk pricing quote.