品質試験/安定性試験

品質試験/安定性試験

米国FDAに評価された品質管理体制(GMP)に基づき、研究開発ステージから商用製造ステージにおける医薬品の品質を物理化学的手法、生化学的手法および微生物学的手法を用いて分析し、評価します。

 

主なサービス内容

  • 品質試験各測定項目に対応
  • 試験法開発から分析法バリデーションへの対応
  • 様々な保存条件に対応した安定性試験の実施

技術情報

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