UV spectrophotometers can analyze organic compounds in pharmaceuticals today. Qualitative information provided convinced the patient’s health and safety. Qualitative analysis of organic compounds can be achieved through a simple process of UV spectrophotometry. UV spectrophotometer measures the areas seen from ultraviolet light and can provide valuable information about the level of active ingredients in pharmaceutical compounds, and detect impurities. By measuring the absorption of UV light radiation, spectrophotometric analysis can measure these levels at a very accurate level.
This chapter includes the use of spectrophotometry in the pharmaceutical industry. Applications where these spectroscopic techniques are used contributing significantly to analytical processes. For example, particle size and distribution may be very important for the function of the drug, and the level of high quality control of the dissolution process. In this specific application, UV spectrophotometer and fluorescence always provide detectors for instrumental-based systems. Most of the need for accurate optical property measurements comes from the need to control the purity and dosage of the drug, in the development, manufacture, and control of product quality, and therefore at the beginning of this chapter, we discuss the general review of this process. Regulatory demands also place the requirements of “evidence of control” on the composition and stability of pharmaceutical products, and thus data evidence related to this process. The spectrophotometric method plays an important role in this data generation, and risk evaluation associated with this process, thus helping compliance. Validation of this process with respect to analytic control of the instrument system and the methodology used is explained. The practical implementation of the concepts of general quality, to control the spectrophotometric system that is seen under ultraviolet, infrared, mid-infrared, and fluorescence is then discussed, along with examples of specific application areas where each of these techniques is used. Finally, regulation of ways that might affect the use of future spectrophotometry in the pharmaceutical industry is discussed.
Operational SOPs for UV Spectrophotometer
Calibration SOPs for UV Spectrophotometer
Installation Qualification of UV Spectrophotometer
Operational Qualification of UV Spectrophotometer
Performance Qualification of UV Spectrophotometer