Introduction to Industrial Pharmaceutical Analysis

General Foundation

After the succesful end of the course, postgraduates will be able to develop an analytical method for the quantification of two or three substances in pharmaceutical formulations. In addition, postgraduates are trained in all the “in process “ analytical methods related to the release of a batch from the production unit to consumption.

• Introduction to analytical concepts. Quality control of analytical methods. Terms used in Analytical Process Control. Basic calculations in pharmaceutical analysis. • Evaluations and statistical processing of analytical results with application. Pharmacopoeias and their usability as appropriate tools for the application of analytical methods. Create an internal/external standard reference curve. • Ultraviolet spectrophotometry in medicinal substances and in medicinal plants. • Quantitative determination of active substance in tablets, with a UV detector (Raw material control:). Identification by the use of external calibration model of one point. • Descriptive statistics, estimation, measurement uncertainty and confidence limits. • General principles of Atomic Emission and Absorption Spectrometry. Control of heavy metal impurities in raw materials by ICP-AES inductively coupled plasma atomic emission spectrometry. • “In process” Drug control methods. • Content Uniformity Test. Fragmentation time test. Brittleness test. Control of height (thickness) of tablets. Mechanical strength test of tablets. • Stability study of agents using infrared spectrophotometry. • Dissolution process. Dissolution rate control with UV spectrophotometry. • Content uniformity control with UV spectrophotometry. • Spectrophotometry of derivatives • Development of an analytical “UV derivative ratio“ method for the determination of two or three APIs • General principles of X-rays, X-ray diffraction • FTIR spectra for drug identification. • Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA).

28-02-2024