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Characteristics of an Excellent API Synthesis Process

Feasibility

  Whether the adopted process route can produce the target compound

  Whether the reaction conditions can meet the requirements of the industrial process route for raw materials, equipment, and reaction conditions in the commercial production

  Resolution of waste management issues

Controllability

  Good reproducibility

  Consistency in product quality between batches, meeting expected quality standards

Rationality

  Raw materials: readily available

  Selection of solvents and reagents: Preferably low toxicity, in accordance with ICH guidelines

  EHS: Environmental protection and labor protection comply with laws and regulations

  Cost: Competitive