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Tags: Potency monitoring

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  1. Benchtop NIR method development for continuous manufacturing scale to enable efficient PAT application for solid oral dosage form

    Contributor(s):: Alam, MA, Liu, YADolph, S, Pawliczek, M, Peeters, E, Palm, A

    A Near Infrared (NIR) method was developed using a small benchtop feed frame system to quantify Saccharin potency in a powder blend during continuous manufacturing process. A 15-point Design of Experiments (DoE) was created based on the NIR spectral response and compositions of the formulation to...

  2. An agile and robust in-line NIR potency deviation detection method for monitoring and control of a continuous direct compression process

    Contributor(s):: Alam, Md Anik, Liu, Yang Angela

    Near Infrared (NIR) method for blend potency estimation has been commonly used as an essential tool for process monitoring and control in continuous manufacturing of solid oral dosage forms. Robustness has been the main challenge for successful application of an NIR method, which often results in...