Quality Assurance for Methyl 2-cyclohexyl-2-hydroxy-2-phenylacetate in Pharmaceutical Manufacturing
In the pharmaceutical sector, the quality of every component, especially chemical intermediates, is non-negotiable. Methyl 2-cyclohexyl-2-hydroxy-2-phenylacetate, identified by CAS 10399-13-0, is a crucial intermediate in the synthesis of Oxybutynin. Ensuring its consistent quality is paramount for the safety and efficacy of the final drug product. NINGBO INNO PHARMCHEM CO.,LTD. places a strong emphasis on robust quality assurance protocols for this compound.
The primary indicator of quality for Methyl 2-cyclohexyl-2-hydroxy-2-phenylacetate is its purity, typically specified at a minimum of 98%. Manufacturers rely on analytical techniques such as High-Performance Liquid Chromatography (HPLC) to verify this purity. Beyond purity, detailed specifications regarding appearance (white crystalline powder), molecular formula (C15H20O3), and molecular weight (approx. 248.32 g/mol) are meticulously documented and verified. For buyers, understanding these specifications and the supporting documentation, such as Certificates of Analysis, is key when evaluating suppliers of Methyl 2-cyclohexyl-2-hydroxy-2-phenylacetate.
Storage and handling also play a significant role in maintaining the quality of this intermediate. Recommended storage conditions, often involving a -20ºC freezer to ensure stability, and appropriate packaging (e.g., 25kg cardboard drums) are critical to prevent degradation. Suppliers like NINGBO INNO PHARMCHEM CO.,LTD. adhere to these guidelines to deliver a product that meets stringent requirements. The stability data and recommended shelf-life for Methyl 2-cyclohexyl-2-phenylacetate are important considerations for inventory management.
The application of Methyl 2-cyclohexyl-2-hydroxy-2-phenylacetate as an intermediate for Oxybutynin means that any compromise in its quality could have serious implications for patient health. Therefore, rigorous quality control measures are implemented at every stage, from synthesis to packaging and shipping. This commitment to quality is a hallmark of reliable pharmaceutical chemical suppliers. When considering the purchase of this chemical, buyers should always look for suppliers who demonstrate a strong commitment to quality assurance, as exemplified by companies like NINGBO INNO PHARMCHEM CO.,LTD.
In conclusion, the quality assurance of Methyl 2-cyclohexyl-2-hydroxy-2-phenylacetate is a cornerstone of effective pharmaceutical manufacturing. By focusing on purity, proper handling, and verified specifications, the industry can ensure the safety and efficacy of medications derived from this vital intermediate. The commitment of NINGBO INNO PHARMCHEM CO.,LTD. to these principles makes them a valuable partner for pharmaceutical companies worldwide.
Perspectives & Insights
Bio Analyst 88
“Methyl 2-cyclohexyl-2-hydroxy-2-phenylacetate, identified by CAS 10399-13-0, is a crucial intermediate in the synthesis of Oxybutynin.”
Nano Seeker Pro
“Ensuring its consistent quality is paramount for the safety and efficacy of the final drug product.”
Data Reader 7
“The primary indicator of quality for Methyl 2-cyclohexyl-2-hydroxy-2-phenylacetate is its purity, typically specified at a minimum of 98%.”