For procurement managers in the pharmaceutical industry, sourcing critical intermediates like (R)-5-Hydroxymethyl Tolterodine (CAS: 207679-81-0) requires a strategic approach. This compound is integral to the synthesis of Fesoterodine Fumarate, a widely prescribed medication for overactive bladder (OAB). Ensuring a consistent, high-quality supply is not just about cost; it's about maintaining production timelines and the integrity of the final drug product. This guide outlines key considerations for purchasing this essential pharmaceutical intermediate.

Understanding the Product: (R)-5-Hydroxymethyl Tolterodine

(R)-5-Hydroxymethyl Tolterodine is characterized as a pale yellow solid with a high purity, typically above 98.0%. Its chemical structure is vital for its role as a precursor to Fesoterodine Fumarate. When researching suppliers, focus on those who can provide detailed Certificates of Analysis (CoA) and technical data sheets that confirm these specifications. As a buyer, it’s important to know the CAS number (207679-81-0) and common synonyms like Desfesoterodine or 5-HMT for accurate sourcing.

Key Factors in Supplier Selection:

When looking to purchase (R)-5-Hydroxymethyl Tolterodine, several factors are critical for selecting the right manufacturer or supplier:

  1. Quality Assurance and Compliance: A primary concern is the supplier's adherence to Good Manufacturing Practices (GMP) or similar quality standards relevant to pharmaceutical intermediates. Verify if they have robust quality control systems in place, including batch-to-batch consistency testing.
  2. Production Capacity and Lead Times: Assess the supplier's ability to meet your volume requirements and their typical lead times for delivery. For critical intermediates, having a supplier with scalable production capabilities and reasonable delivery schedules is crucial. Manufacturers in China, like NINGBO INNO PHARMCHEM CO.,LTD., often excel in this regard.
  3. Technical Support and Documentation: A responsive supplier will offer comprehensive technical support, including product specifications, safety data sheets (SDS), and regulatory documentation. Access to reliable CoAs for each batch is non-negotiable.
  4. Pricing and Payment Terms: While cost is always a factor, it should be balanced against quality and reliability. Obtain quotes from multiple suppliers, compare pricing structures, and understand their payment terms. Requesting a quote for (R)-5-Hydroxymethyl Tolterodine is the first step in assessing cost-effectiveness.
  5. Logistics and Packaging: Understand the standard packaging (e.g., 25 kg drums) and storage recommendations (cool, ventilated place). Ensure they can handle international shipping and any specific import requirements your country might have.

The Importance of Reliable Sourcing for Fesoterodine Fumarate:

Fesoterodine Fumarate is a prodrug that is metabolized into the active form, 5-hydroxymethyl tolterodine, to treat OAB. This means the purity and quality of the (R)-5-Hydroxymethyl Tolterodine intermediate directly influence the safety and efficacy of the final drug. A compromised intermediate could lead to:

  • Reduced yield in synthesis.
  • Presence of unwanted impurities in the final API.
  • Regulatory compliance issues.
  • Production delays impacting market availability.

Therefore, meticulously vetting your suppliers for (R)-5-Hydroxymethyl Tolterodine is a fundamental aspect of pharmaceutical supply chain management. Focusing on established manufacturers in regions like China known for chemical synthesis expertise can provide both quality and economic benefits.

Conclusion

Procuring (R)-5-Hydroxymethyl Tolterodine involves more than just finding the lowest price. It requires a thorough evaluation of suppliers based on quality, reliability, and technical capabilities. By partnering with reputable manufacturers, pharmaceutical companies can secure a consistent supply of this vital intermediate, ensuring the efficient and safe production of Fesoterodine Fumarate and ultimately contributing to better patient outcomes in OAB treatment. For your sourcing needs, consider engaging with experienced suppliers like NINGBO INNO PHARMCHEM CO.,LTD. to get competitive pricing and reliable supply.