Pharmaceutical Analysis

Code:

QF13003

Acronym:

AF

Keywords
Classification	Keyword
CNAEF	Pharmaceutical Sciences

Instance: 2021/2022 - 1S

Active?	Yes
Responsible unit:	Organic and Pharmaceutical Chemistry Laboratory
Course/CS Responsible:	MSc in Pharmaceutical Chemistry

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MQF	22	Official Curriculum	1	-	6	50	162

Teaching language

Portuguese

Objectives

 It is intended that students know the techniques used in the official control of pharmaceutical products (raw materials and final products). To study and implement in an integrated way, the main methodologies used in the purification and pharmaceutical analysis as a basis for quality assessment and characterization of official substances and pharmaceuticals. The knowledge of the purity required for products of use in pharmacy and medicine, structure and organization of the main official codes, and of the importance of the reference substances and certificated materials allow the students to rationalize more efficiently the pharmaceutical analysis and fit it within the proper context. Objectives are also the use of appropriately techniques of separation, identification and determination as well as learning how to validate an analytical method.

Learning outcomes and competences

Knowledge of the techniques used in official control of substances and pharmaceutical products (raw materials and finished products) and the ability to apply this knowledge. How to evaluate the quality of the substances used in pharmacy.

Working method

Presencial

Pre-requirements (prior knowledge) and co-requirements (common knowledge)

Basic knowledge of Organic and Analytical Chemistry.

Program

 

Syllabus:

 

I. Theoretical

 

- Pharmaceutical Analysis in the safety and quality control of pharmaceutical substances and products.

 

- Activity and role of Regulatory Authorities

 

- Formularies and National Pharmacopoeias. Guidelines of the International Conference on Harmonization for good analytical and manufacturing practices.

 

- Purity required for pharmaceutical substances. Specification of impurities.

 

- Chemical reference substances and certified reference materials.

 

- Extraction techniques: Classical; SPE; SPME; supercritical fluid

 

- Spectrophotometric techniques: UV-Vis; IR; NMR

 

- Techniques for the separation: TLC; HPLC: LC-MS; GC, GC-MS; Electrophoresis

 

- Assay methods in the official codes.

 

- Validation of analytical methods.

 

- Interpretation of the chemical reactions of the identification tests in pharmacopoeias.

 

 

 

II. Experimental

 

Discussion and resolution of various problems of Pharmaceutical Analysis.

 

Mandatory literature

Watson David G.; Pharmaceutical analysis. ISBN: 0-443-07445-3

Complementary Bibliography

Lee David C. 340; Pharmaceutical analysis. ISBN: 1-84127-335-X
Schirmer Roger E. 340; Modern methods of pharmaceutical analysis. ISBN: 0-8493-5245-2

Teaching methods and learning activities

 

Lectures, using power-point presentations, will correspond to explanations and will promote discussion and interaction with students, as well as the interrelation of knowledge and critical thinking of students.

 

The experimental works are conducted according to a schedule previously communicated to the students. Exercises considered relevant for learning and objectives of the curricular unit will be discussed.

 

keywords

Health sciences > Pharmacological sciences > Pharmacy
Physical sciences > Chemistry > Applied chemistry > Pharmaceutical chemistry

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	100,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	75,00
Frequência das aulas	25,00
Total:	100,00

Eligibility for exams

Execution of the planned laboratory work.

Calculation formula of final grade

Final examination = 100%