(S)-Ibuprofen Pharmaceutical Intermediate: Quality, Supply, and Manufacturer Details
In the complex landscape of pharmaceutical manufacturing, the selection of high-quality raw materials and intermediates is a critical determinant of final product efficacy and safety. (S)-Ibuprofen, a vital pharmaceutical intermediate, plays a significant role in the synthesis of various Active Pharmaceutical Ingredients (APIs), particularly those within the NSAID class. For procurement managers and R&D scientists, understanding the characteristics of this compound, its supply chain, and the capabilities of its manufacturers is essential. This article provides a comprehensive overview of (S)-Ibuprofen as a pharmaceutical intermediate, focusing on quality, supply chain considerations, and choosing the right manufacturing partner.
What is (S)-Ibuprofen?
(S)-Ibuprofen is the biologically active enantiomer of Ibuprofen, a well-known non-steroidal anti-inflammatory drug. While racemic Ibuprofen is widely available, the (S)-enantiomer possesses the primary therapeutic activity. Its chemical structure and properties make it an indispensable building block in the synthesis of APIs where stereochemical integrity is crucial. The compound is typically supplied as a white powder and is identified by its CAS number: 51146-56-6.
Quality Standards for Pharmaceutical Intermediates
When sourcing (S)-Ibuprofen for pharmaceutical use, adherence to stringent quality standards is non-negotiable. Key quality parameters include:
1. Chemical Purity: Manufacturers aim for purity levels of 99% or higher, as indicated in specifications. This ensures minimal contamination from synthesis by-products.
2. Enantiomeric Purity: For chiral intermediates like (S)-Ibuprofen, enantiomeric excess (ee) is a critical metric. High ee ensures that the desired active enantiomer is predominant.
3. Physical Characteristics: Consistent appearance (e.g., white powder) and adherence to specified physical properties are important for processability.
4. Documentation: Comprehensive documentation, including Certificates of Analysis (CoA), detailing assay, impurity profiles, and physical characteristics, is vital for regulatory compliance and quality assurance.
Ensuring a Reliable Supply Chain
For pharmaceutical manufacturers, a stable and consistent supply of intermediates is paramount. When you buy (S)-Ibuprofen, consider the supplier's production capacity and their ability to meet demand fluctuations. Manufacturers with significant production capabilities, such as those with a capacity of 20t/Year, can offer greater supply chain security. It is also beneficial to assess their logistical capabilities, ensuring timely and safe delivery of products, whether domestically or internationally. Building a strong partnership with a supplier, potentially through long-term contracts, can further enhance supply chain stability.
Choosing the Right Manufacturer
Selecting a manufacturer for (S)-Ibuprofen involves evaluating several aspects:
1. Manufacturing Expertise: Look for manufacturers with proven experience in chiral synthesis and purification techniques.
2. Quality Management Systems: Certifications like ISO 9001 or adherence to GMP principles in intermediate manufacturing indicate a commitment to quality.
3. Competitive Pricing: While quality is paramount, competitive pricing, especially for bulk orders, is a significant factor. Sourcing from manufacturers in regions like China can often provide cost advantages.
4. Technical Support: A responsive supplier that can offer technical assistance and address queries regarding product specifications and applications is invaluable.
In conclusion, (S)-Ibuprofen is a crucial pharmaceutical intermediate demanding high standards of quality and a reliable supply chain. By understanding its properties, prioritizing rigorous quality control, and partnering with experienced manufacturers, pharmaceutical companies can ensure the successful synthesis of APIs and the delivery of safe, effective medications.
Perspectives & Insights
Quantum Pioneer 24
“Sourcing from manufacturers in regions like China can often provide cost advantages.”
Bio Explorer X
“Technical Support: A responsive supplier that can offer technical assistance and address queries regarding product specifications and applications is invaluable.”
Nano Catalyst AI
“In conclusion, (S)-Ibuprofen is a crucial pharmaceutical intermediate demanding high standards of quality and a reliable supply chain.”