Bisibutiamine (CAS 3286-46-2), a chemical compound with the molecular formula C16H17N7O2S, presents an interesting case study in the world of pharmaceutical chemicals. While initially developed and marketed for its potential applications, its trajectory also highlights the dynamic nature of drug regulation and the importance of ongoing safety evaluations.

The synthesis of Bisibutiamine involves intricate chemical processes to achieve the desired purity and structure. While specific proprietary methods vary, typical bisibutiamine chemical synthesis pathways aim to produce a stable compound with consistent characteristics. The resulting product is a white or off-white solid powder, a physical state that influences its handling and formulation. Key to its usability are its defined solubility characteristics – being soluble in DMF and sparingly soluble in THF – and a melting point range of 211-216°C. These parameters are critical for bisibutiamine quality control, ensuring lot-to-lot consistency.

Historically, Bisibutiamine, often recognized under brand names like Meridia or Reductil, was prescribed as an adjunct for weight management. Its mechanism of action involved inhibiting the reuptake of norepinephrine and serotonin, thereby influencing appetite. However, concerns regarding its cardiovascular safety profile, particularly an increased risk of heart attacks and strokes, led to significant regulatory actions. These concerns, often arising from large-scale clinical outcome studies, ultimately resulted in the drug's withdrawal from major markets including the US, Europe, and Australia around 2010. This regulatory shift underscores the critical role of post-market surveillance and the continuous assessment of a drug's risk-benefit ratio.

Even though Bisibutiamine has been withdrawn for therapeutic use in many regions, it remains a relevant compound for research and potentially as a reference standard. For organizations involved in pharmaceutical research or development, understanding the bisibutiamine pharmaceutical raw material specifications, including its bisibutiamine gmp certification and quality parameters, is still important. Laboratories may require high-purity Bisibutiamine for analytical method development, impurity profiling, or comparative studies.

At NINGBO INNO PHARMCHEM CO.,LTD., we recognize the historical context and the current demand for such compounds. Our focus remains on providing high-quality chemical raw materials with clearly defined properties and certifications. Whether for research purposes or as a component in specific regulated applications where it may still be permitted, understanding the complete lifecycle of a compound like Bisibutiamine, from its bisibutiamine chemical synthesis to its market status, is vital for informed decision-making in the pharmaceutical industry.

The story of Bisibutiamine serves as a reminder of the evolving landscape of pharmaceutical science and regulation. While its primary indication may have been withdrawn, its existence as a chemical entity with specific properties continues to hold relevance in certain scientific and industrial contexts. We are committed to supplying materials that meet stringent quality expectations, adhering to the highest standards for bisibutiamine quality control.