No

Module Name

Drug Quality Control

1

Code of Subjects

P10A02.0406

2

Study load

2(2-0) credits

Contact hour per semester: 27

Independent study hour per semester : 64

Total workload : 91

3

Semester

4

4

Precondition

P10A.0205

5

Competence

After graduating from this course, students are expected to be able to:

1. Understand and analyze the quality test of raw materials
2. Understand qualitative and quantitative testing to test the quality of raw materials
3. Analyzing liquid, semisolid, and solid preparations as well as cosmetics using UV-Vis spectrophotometry method
4. Analyzing liquid, semisolid and solid preparations as well as cosmetics using high performance liquid chromatography method
5. Able to analyze liquid, semisolid, and solid and cosmetic preparations using gas chromatography method
6. Able to select and apply appropriate analytical methods from UV-Vis spectrophotometry, high performance liquid chromatography and gas chromatography for liquid, semisolid, solid and cosmetic preparations appropriately

6

Elements of Competency

MKK

7

Type Competency

Main competence

8

Syllabus

This course discusses the analytical methods of raw materials and solid, semisolid, liquid and cosmetic preparations, in single or mixed forms using instrumentation including UV-Vis spectrophotometry with standard addition and derivative methods, high performance liquid chromatography, and gas chromatography.

9

Attribute Soft Skill

Ethics, awareness, discipline

10

Learning methods

Presentation, lecturer, discussion, project

11

Learning Media

LCD Projector

12

Appraisal

Self-Reflection : 10% 

Assignment : 20% 

Mid-Exam : 35%

Final-Exam : 35%

13

Lecturer

Dr. Aliya Nur Hasanah, M.Si., Apt., Dr. Rimadani Pratiwi, M.Si., Apt, Driyanti Rahayu MT, and Holis A. Holik, Ph.D

14

References

1. Instrumental method analysis, Skoog, 2013
2. Mitra A. Fundamentals of quality control and improvement. 4th ed. John Wiley & Sons Inc. 2016.
   
3. Chowdary KPR. A Textbook of Pharmaceutical Assurance. PharmaMed Press/BSP Books. 2020.
   
4. Kashi AR, Sukumaran B, Veena P. Pharmaceutical Quality Assurance. 2020.