Certificate of Advance Pharmaceutical Analysis

  • The students will learn the theory, principle and practices of drug analysis, analytical methodology, the most important chemical, physical techniques and instrumentation. You will practice main pharmaceutical analytical instruments such as HPLC, dissolution apparatus, titrator, pH-meter, viscometer, balance, and pipette etc. The students will understand limit, purity, content uniformity, dissolution, identification, assay, related substances test, stability study and number of other widely used analytical tests following USP
    •  Introduce Pharmaceutical Industry
        Introduce Pharmaceutical Quality Control
        Project; Raw Material & Finished Products Responsibility
  • Good Laboratory Practices
      Food and Drug Administration Regulation
      International Conference on Harmonisation Regulation
      Good Manufacturing Practices & SOPs
      Project ; SOP writing
  •  Specification and Analytical Monograph
      US. Pharmacopoeia (USP)
      British Pharmacopoeia (BP)
      European Pharmacopoeia (EP)
      Japanese Pharmacopoeia (JP)
      Project; Create nonofficial Monograph and C of A
  •   US. Pharmacopoeia Reference Standards
      Volumetric Apparatus
      Weights and Balance
      Good Manufacturing Practices for Bulk Pharmaceutical Excipients
      Impurities in Official Articles
      In Vitro and in Vivo Evaluation of Dosage Forms
      Labeling of Inactive Ingredients
      Tablet Friability
      Reagent and Solution
      Practice and Project
  •  Identification Tests
         • Spectrophotometric Identification Tests
         • Thin-Layer Chromatographic Identification Test
      Limit Tests
         • Manual Titration
             Indicator and pH Meter
             Practice; Assay Test by Titration
         • Auto Titration
  •  High Performance Liquid Chromatography (HPLC)
        • Theory and Principle of HPLC System
        • HPLC (Agilent 1200/1100 , Waters) System
        • Software ; ChemStation Plus and ChemStation 1200, Empower and Millennium 32
        • Perform HPLC Tests
             Identification, Assay, Content Uniformity, Related Substances, Limit and Purity,
             Blend Assay, Cleaning Validation and Stability Study
        • HPLC Troubleshooting
             System Problem, Personal Problem and Monographic Problem
      Gas Chromatography
        • Theory, Principle and Practice of GC System
        • Theory, Principle and Practice of UV-Vis System with ChemStation
  •  Dissolution System, USP Tests and Practice Profile Dissolution Test 
  •  Karl Fischer ; Titrimetric, Azeotropic and Gravimetric