Certificate of Advance Pharmaceutical Analysis
Practice of Pharmaceutical Quality Control
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 Quality Control
Introduce Pharmaceutical Industry
Introduce Pharmaceutical Quality Control
Project; Raw Material & Finished Products Responsibility
GLP, GMP, FDA & ICH regulation
Good Laboratory Practices
Food and Drug Administration Regulation
International Conference on Harmonisation Regulation
Good Manufacturing Practices & SOPs
Project ; SOP writing
Pharmacopoeia
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 General Chapter
US. Pharmacopoeia Reference Standards
Thermometers
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
Raw Material Quality Control Tests
Identification Tests
• Spectrophotometric Identification Tests
• Thin-Layer Chromatographic Identification Test
Limit Tests
Titrimtry
• Manual Titration
Indicator and pH Meter
Practice; Assay Test by Titration
• Auto Titration
Chromatography Test
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
UV-Vis
• Theory, Principle and Practice of UV-Vis System with ChemStation
Dissolution Test
Dissolution System, USP Tests and Practice Profile Dissolution Test
Water Content Test
Karl Fischer ; Titrimetric, Azeotropic and Gravimetric
Data analysis and documentation
