Скачать или смотреть Practice School (DOMAIN 1) Active Pharmaceutical Ingredients and Impurity Profiling

DOMAIN 1-Active Pharmaceutical Ingredients and Impurity Profiling
Course Contents

Module 1: Laboratory safety 10 hrs
1. Introduction to laboratory safety
2. Introduction to hazardous chemicals and MSDS
3. Introduction to handling of chemicals and safety requirement

Module 2: Laboratory Techniques 60 hrs
1. General techniques
2. Chromatography
3. Crystallization
4. Extraction
5. Distillation
5.1 Overview of Distillation
5.2 Simple Distillation
5.3 Fractional Distillation
5.4 Vacuum Distillation
5.5 Steam Distillation
5.6 Rotary Evaporation
6. Other Techniques
Determination of Melting point, Boiling Point, Sublimation and Chemical Tests
7. Reaction Workups

Module 3: API Technology 40 Hrs
1. Overview of API, API intermediates and fine chemicals industry
2. Unit processes in synthesis:
3. Optimization of Organic Reactions and Processes
4. Industrial processes & scale up techniques: Industrial manufacturing methods and flow charts of APIs
5. Chirality in API Industry, Resolution of racemate, Asymmetric synthesis, few case Studies
6. Polymorphism in APIs
7. APIs: Brief overview of QA/QC, GMP guidelines in API manufacturing (ICH Q7,Q7Aand Q11)

Module 4: Experimental Techniques 30 hrs
1. Purification and Impurity control in APIs
2. Biologicals (Biotechnological Products) as API
3. Regulations for Biologicals
4. Packaging and Repackaging of APIs .

Module 5: Report Writing 10 hrs
Preparation of a report on practice school

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