CHAPTER VIII: PHYSICAL ANALYSIS METHODS FOR CHEMICAL PREPARATIONS IN PHARMACY
Résumé de section
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Physical analysis methods form the first line of assessment in pharmaceutical quality control, providing fundamental, rapid, and often non-destructive means of evaluating chemical substances. These techniques focus on measuring the intrinsic physical properties of a material such as its color, density, melting point, and optical characteristics rather than its chemical reactions. This chapter details the standard procedures for these essential tests, which are critical for confirming identity, assessing purity, and ensuring batch-to-bustch consistency. From the visual assessment of a solution's colour to the precise determination of a compound's specific rotation, these methods are indispensable for verifying that raw materials and finished products comply with stringent pharmacopoeial standards before they are released for therapeutic use.
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Upon completing this chapter, the student will be able to: 1. Explain the fundamental principle and pharmacopoeial procedure for determining the colour of liquids and its significance in purity assessment.
2. Differentiate between mass density and relative density, and describe the pycnometer method for their determination.
3. Define melting point, boiling point, and congealing point, and relate their determination to the identification and purity testing of pharmaceutical substances.
4.Compare the principles of Loss on Drying and Karl Fischer titration for water content determination, identifying the advantages and limitations of each.
5. Apply the principles of Polarimetry to calculate specific rotation and explain its critical role in characterizing chiral active pharmaceutical ingredients.
6. Describe the principle of refractive index measurement and its application in identifying liquid substances and testing their purity
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