Educational guide
IDENTIFYING DATA 2024_25
Subject ANALYTICAL QUALITY CONTROL Code 01737111
Study programme
1737 - MASTER UNIVERSITARIO EN PRODUCCION DE INDUSTRIAS FARMACEUTICAS
Descriptors Credit. Type Year Period
3 Compulsory First Second
Language
Castellano
Prerequisites
Department QUIMICA Y FISICA APLICADAS
Coordinador
PEREIRA GARCÍA , FERNANDO JOSE
E-mail fjperg@unileon.es
jcfeom@unileon.es
lcrobg@unileon.es
Lecturers
FEO MANGA , JOSÉ CRUZ
ROBLES GARCÍA , LUIS CARLOS
PEREIRA GARCÍA , FERNANDO JOSE
Web http://
General description The subject "Analytical Quality Control" is a fundamental course that lays the groundwork for understanding and properly applying the fundamental aspects of all stages comprising analytical control within the pharmaceutical industry.
Tribunales de Revisión
Tribunal titular
Cargo Departamento Profesor
Presidente FERNANDEZ RODRIGUEZ , CAMINO
Secretario QUIMICA Y FISICA APLICADAS LOPEZ GONZALEZ , ROBERTO
Vocal DIDACT.GRAL,ESPEC.Y TEORIA EDU PINO GUTIERREZ , FRANCISCO JAVIER DEL
Tribunal suplente
Cargo Departamento Profesor
Presidente QUIMICA Y FISICA APLICADAS MARTIN VILLACORTA , JAVIER
Secretario QUIMICA Y FISICA APLICADAS CARA JIMENEZ , JORGE
Vocal MARTINEZ TORRES , ELIA JUDITH


Topic Sub-topic
I. Quality Control Lesson 1. Introduction to Drugs' Quality Control
Lesson 2. The Analytical Method applied to Quality Control. Statistics support
II. Sample preparation Lesson 3. Sampling and sample pretreatment
III. Chromatographic separations Lesson 4. Chromatographic separations: HPLC, LC-MS
IV. Spectroscopic techniques Lesson 5. Molecular spectroscopic techniques: UV-Vis, IR, Raman
Lesson 6. Atomic spectroscopic techniques: atomic absorption and emission spectroscopy
V. Practical program: laboratory experimentation The pretreatment of a pharmaceutical sample, to separate its components, and its chemical characterization and quantification will be performed applying one or various analytical techniques previously studied.

Methodologies  ::  Tests
  Class hours Hours outside the classroom Total hours
Problem solving, classroom exercises 6 11 17
 
Laboratory practicals 5 7 12
 
Lecture 17 26 43
 
Objective multiple-choice tests 2 0 2
Practical tests 0 1 1
 
(*)The information in the planning table is for guidance only and does not take into account the heterogeneity of the students.

Methodologies   ::  
  Description
Problem solving, classroom exercises Formulation, analysis, resolution, and debate of a problem or exercise related to the subject matter of the course.
Laboratory practicals Apply, at a practical level, the theory from a specific knowledge area within the context of pharmaceutical products.
Lecture Presentation and discussion of the theoretical foundations of the course.

 
Lecture
Problem solving, classroom exercises
Laboratory practicals
Description
The student has several pre-scheduled tutoring hours per week. However, the student also has the option to access the faculty by visiting their office during regular working hours to address doubts or any other questions.

  Description Qualification
Lecture Objective exam with questions and exercises 6
Problem solving, classroom exercises 3
Laboratory practicals Continued 1
Objective multiple-choice tests
Practical tests
 
Other comments and second call

The use and possession of electronic devices that enable communication (mobile phones, radios, etc.) are strictly prohibited. In the event of any irregularity occurring during the assessment tests, based on the corresponding current regulations, the exam will be confiscated, the student will be expelled from the test, and it will be graded as a fail.


Basic
BASIC

- D.A. Skoog, D.M. West, F.J. Holler, S.R. Crouch. Fundamentos de Química Analítica. Ed. Brooks/Cole (Cengage Learning), 9ª, 2017.

- D.A. Skoog, F.J. Holler, S.R. Crouch. Principios de Análisis Instrumental. Ed. Cengage Learning, 7ª , 2018.

- M.G. Volonté y P. Quiroga. Análisis farmacéutico. Ed. Universidad de La Plata, 1ª, 2013.

- International Conference on Harmonisation (ICH). Validation of Analytical Procedures, 2023.
Complementary
COMPLEMENTARY

- C. Cámara (Ed.): Toma y tratamiento de muestras, Editorial Síntesis, Madrid, 2002.

- C. Barbé Rocabert, Preparados farmacéuticos y parafarmacéuticos. Barcelona: Masson, 2001.

- D.C. Harris: Análisis Químico Cuantitativo. Ed. Reverté, S.A., 2001.

- M.J. Llopis Clavijo, V. Baixauli Comes, La formulación magistral en la oficina de farmacia. Valencia: Distribuciones Cid, 1997.