Near-infrared analytical control of pharmaceuticals. A single calibration model from mixed phase to coated tablets

摘要: A new method for analysis of the active compound in a commercial pharmaceutical formulation different steps production cycle, based on near-infrared diffuse reflectance spectroscopy, is proposed. The includes three cycle: granules ready compression (mixed phase), cores (intermediate) and coated tablets (final product). Satisfactory predictive results samples, independently its origin require calibration with laboratory-made samples covering concentration range involved manufacturing process, also from various batches steps, which introduce variation sources inherent such process. global sole model was found to determine during errors prediction less than 1.8% all cases. Tablets can be individually analysed high accuracy precision, so content uniformity may performed.