关于滴眼液（混悬）的原辅料相容性怎么做?凡是液体制剂，原辅料相容性不适用，建议看下文Formulation-supporting studies. In finalizing the formulation, a number of supporting studies are needed to address the biological or patient-related issues, support the manufacturing process, and define the boundaries under which the product’s qualities will be maintained throughout the shelf life of the product. 1. Biological considerations: a. Evaluation of impact of formulation toward hemolysis, precipitation, phlebitis, and pain on injection b. Tonicity 2. Manufacturing and handling support studies: a. Compatibility with commonly used diluents and IV administration sets, etc. b. Compatibility with manufacturing equipment c. Compatibility with membrane filters, if aseptic processing is used during the manufacture d. “In-use” stability studies e. Feasibility of terminal sterilization f. Photostability查看更多
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