The manufacturing engineering analysis method of pharmaceuticals

摘要

PROBLEM TO BE SOLVED: To provide a method for process analysis which can give you precise and highly reproducible knowledge of the state of coating of an inspection target particle group in a bulk state.SOLUTION: The method for process analysis includes the steps of: measuring the fluorescent X-ray of an inspection target particle group where a coating layer is formed on a nuclear particle; and evaluating the state of coating of the inspection target particle group on the basis of the fluorescent X-ray measured by the fluorescent X-ray measurement step, at least one of the nuclear particle and the coating layer containing a medicine and/or an additive which contains an element that emits a fluorescent X-ray.SELECTED DRAWING: Figure 1