Laboratory Techniques in Aseptic Manufacturing

Abstract

The use of complex and advanced analytical techniques for the evaluation of the quality of drug substances and excipients used in parenteral formulations is becoming increasingly feasible. Techniques for the determination of physicochemical properties are summarized under Physical and Chemical Methods. Separation Methods include extraction and chromatography Methods for identification and analysis using spectroscopies are included under Spectroscopic Methods and techniques based on immunological reactions are included under Immunological Methods. The current Food and Drug Administration guidelines for the Inspections of Pharmaceutical Quality Control Laboratories and the Inspections of Microbiological Pharmaceutical Quality Control Laboratories are appended to this chapter. Physical and chemical methods are extensively used in pharmaceutical analyses of sterile products and constitute a variety of techniques that provide information about the structure, purity, and quantitation of active ingredients and excipients. Osmometry determines the tonicity of the injectable solutions—to determine if the solutions are isotonic with blood serum.