Laboratory-scale preparation testing is mainly engaged in exploratory, developmental work, method development and optimization. Laboratory-scale preparation testing is a comprehensive and systematic reform of the original synthetic routes and methods in the laboratory. On the basis of the reform, through batch synthesis in the laboratory and accumulating data, a synthesis process route that is basically suitable for pilot production is proposed. The research at this stage focuses on the key issues affecting industrial production, such as shortening the synthetic route, increasing the yield, simplifying the operation, reducing the cost and safe production.
1. Verify that the instruments required for experiments and inspections are in place.
2. Select suitable raw materials and excipients.
3. Carry out compatibility tests of raw materials and excipients to study the interaction between drugs and between drugs and excipients.
4. Find literature and reduce time for lab-scale testing.
5. Conduct preliminary quality studies.
1. Prescription process design: According to the characteristics of the dosage form and the properties of the drug, several basic prescription processes are formulated.
2. Sample preparation was performed according to the designed formulation process.
3. Evaluation of the basic performance of the formulation process: the basic performance of the formulation is examined, and if the formulation is not qualified, the formulation process needs to be redesigned.
1. A scale-up test is carried out on the determined formulation process to ensure that it finally meets the requirements of the pilot test.
2. In order to ensure the consistency of preparation quality, process reproducibility test is carried out.
3. The influence factor test of the enlarged sample and the compatibility test of the inner packaging material.
4. Quality research.
5. Evaluation of laboratory scale preparation test results.
6. Lab-scale preparation testing concluded.
In laboratory-scale preparation testing, BOC Sciences focuses on mixing uniformity, particle flow, and the potential for segregation during tableting or filling, in addition to final product quality.
