Laboratory-scale Preparation Testing

Services we offer

• Laboratory-scale test of oral solid preparations
  Based on the concept of Quality by Design (QbD), the laboratory-scale test aims to conduct design of experiment (DOE) and research targeting at medium/high risks, after the early determination of quality target product profile (QTPP) critical quality attributes (CQA) and preliminary risk assessment based on CQA. With understanding and control strategy based on the critical material attributes (CMA) and critical process parameters (CPP), the formulation process can be determined and the risks can be lowered.
  If the samples for laboratory-scale tests are approved for batch tests, facilities for pilot-scale tests, such as rotary tablet presses and hopper mixers are recommended to avoid scale-up failure caused by facilities featuring different principles (such as differences between dwell times between single punch tablet press and rotary tablet press).
  We verify our understanding of formulation process by preparing samples for laboratory-scale tests to determine whether the CQA of products of such formulation process can be guaranteed. During laboratory-scale tests, we not only focus on the quality of finished products, but also establish draft quality standards for intermediates. We pay attention to the mixing uniformity, particle fluidity, and the possibility of delamination during tableting or filling.We conduct influencing factor & acceleration tests for 1~3 months based on samples for laboratory-scale tests to explore the stability of samples, to provide reference for the improvement of formulation process, the development of quality standard draft and the stability of subsequent pilot-scale test samples.

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