Production Process Optimization

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Service

• Medicilon’s API production process optimization services include:
  Establishment of API quality standardsEstablishment of central control standardOptimization and determination of important process parametersOptimization and determination of post-processing methodOptimization and determination of purification methodEvaluation and control of process risksProcess safety evaluationAutomatic reaction calorimeter RC1mx, differential scanning calorimeter (DSC) and accelerating rate calorimeter (ARC) to evaluate reaction calorimetry, secondary reactions of raw materials, intermediates, and products (thermal stability evaluation) Establishment of quality standards for raw materials, intermediates, and finished productsImpurity profile researchPreparation of CTD documents

Relevant laboratories

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