DRUG ANALYSIS AND CONTROL

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  • Select activity University: Djilali Bounaama Khemis Miliana Facult...

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    University: Djilali Bounaama Khemis Miliana

    Faculty: Science and Technology

    Department: Material Sciences

    Specialty: PHARMACEUTICAL CHEMISTRY

    Level: Master 2 Pharmaceutical Chemistry

    Module:  Drug Analysis and Control

    Semester: 03

    Coefficient: 03

    Lecturer: Dr. Fizir Meriem.

    specialty: Pharmaceutical Analysis

    Diploma: Doctor in pharmaceutical analysis

    Grade: MCA

    Contact: You can contact me on meriem.fizir@univ-dbkm.dz from 6 a.m.

    Assessment method: The final evaluation is carried out through a final exam. 

    To pass the module, the general average must be greater than or equal to 10 out of 20

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  • Select activity Physicochemical analysis methods

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    •  Physicochemical analysis methods
• Select topic Chapter I: Concept of state system structure in drug quality control.

  Chapter I: Concept of state system structure in drug quality control.
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    Objectives

    ·         Exploring the state system structure in drug quality control

    ·         Examining quality management systems in the pharmaceutical industry

    ·         Understanding the role of pharmacopoeias

    ·         Developing knowledge of quality documentation and standards

     

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  • Select activity CHAT 01

    

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  • Select activity quality management system in industrial pharmacy

    

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  • Select activity Four key features of academic style

    

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• Select topic CHAPTER II - Quality control of drugs in pharmacies

  CHAPTER II - Quality control of drugs in pharmacies
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  • Select activity CHAPTER II - QUALITY CONTROL OF DRUGS IN PHARMACIES

    

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  • Select activity CHAT02

    

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  • Select activity pharmaceutical quality assurance and quality control - العمل في مصانع الادوية🧪

    

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• Select topic Chapter IV: Sampling operations

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  • Select activity CHAT 04

    

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• Select topic Chapter V. PHYSICAL ANALYSIS FOR MEDICINES QUALITY CONTROL

  Chapter V. PHYSICAL ANALYSIS FOR MEDICINES QUALITY CONTROL
  • Select activity Objective To study pharmacopoeial methods of therm...

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    Objective 

    To study pharmacopoeial methods of thermal analysis  used for the quality control of API and drugs.

  • Select activity Course.01 Thermal analysis in leading pharmacopoeias. Melting point determination of API

    

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  • Select activity What is thermal analysis (TA?) | TA explained

    

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• Select topic CHAPTER V. Course.02 Optical methods for medicines quality control. Polarimetry and Refractometry

  CHAPTER V. Course.02 Optical methods for medicines quality control. Polarimetry and Refractometry
  • Select activity OBJECTIVE To create a system of knowledge about th...

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    OBJECTIVE

    To create a system of knowledge about the optical pharmacopoeial methods of medicines quality control on the example  of polarimetry and Refractometry.

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  • Select activity في هذا الدرس، سوف نتعلم كيف نصف الانكسار على أنه تغير سرعة الضوء واتجاهه عند المرور بين أوساط مختلفة الكثافة

    

    في هذا الدرس، سوف نتعلم كيف نصف الانكسار على أنه تغير سرعة الضوء واتجاهه عند المرور بين أوساط مختلفة الكثافة URL

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  • Select activity How a refractometer works - 3D ANIMATION structure, function, areas of application, calibration

    

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• Select topic Chapter VI. Chemical analysis for medicines quality control. Pharmacopoeial titrimetric methods

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  • Select activity Objective Form a system of knowledge about the tit...

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    Objective 

    Form a system of knowledge about the titrimetric pharmacopoeial methods for drugs quality control.

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  • Select activity SUPPLEMENTARY RESOURCES

    

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• Select topic Chapter VII. Physico-chemical methods of drug quality control

  Chapter VII. Physico-chemical methods of drug quality control
  • Select activity Objective: to learn the theoretical and practical ...

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    Objective:

    to learn the theoretical and practical foundations of  ultraviolet and visible spectroscopy; assess the quality of medicine using UV/visible spectroscopy.

  • Select activity CHAPTER VII. PHYSICO-CHEMICAL METHODS OF DRUG QUALITY CONTROL

    

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  • Select activity SR: Fundamentals of modern UV-visible spectroscopy

    

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  • Select activity Spectroscopy || Beer- Lambert's Law

    

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  • Select activity Drug analysis

    

    Drug analysis File

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• Select topic REFERENCES

  REFERENCES
  • Select activity References 1. Pleteneva, T. V., Morozova, M. A., U...

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    References

    1. Pleteneva, T. V., Morozova, M. A., Uspenskaya, E. V., & Khatchaturyan, M. A. (2019). Drugs quality control (Theoretical foundation and practical application): The Coursebook. Open Textbook Library.

    2.Good Manufacturing Practice (GMP):

    US Food and Drug Administration (FDA). Current good manufacturing practice (CGMP) regulations. Accessed August 2, 2023. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

    3.World Health Organization (WHO). Good manufacturing practices for pharmaceutical products: main principles. WHO Technical Report Series, No. 908, Annex 2. Accessed August 2, 2023. https://www.who.int/medicines/areas/quality_safety/quality_assurance/control_laboratories/WHOTRS908Annex2.pdf

    4. ISO 9001:

    International Organization for Standardization (ISO). ISO 9001:2015 Quality management systems -- Requirements. Accessed August 2, 2023. https://www.iso.org/standard/62085.html

    5. Pharmacopeial standards:

    United States Pharmacopeia (USP). General chapter <41> Balances. Accessed August 2, 2023. https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/generalChapter41.pdf

    European Pharmacopoeia (Ph. Eur.). Quality of pharmaceuticals. Accessed August 2, 2023. https://www.edqm.eu/en/european-pharmacopoeia-ph-eur-10th-edition-0

    6.Siddiqui, M. R., AlOthman, Z. A., & Rahman, N. (2017). Analytical techniques in pharmaceutical analysis: A review. Arabian Journal of chemistry, 10, S1409-S1421.

    7.Xu, Z. (2022, March). Considerations on Regulatory Quality Control in Pharmaceutical Industry. In 7th International Conference on Economy, Management, Law and Education (EMLE 2021) (pp. 324-328). Atlantis Press.

    8.Force, A. T. G. T. (2016). QUALITY CONTROL.

    9. FARHAT, Kulsoom. Pharmaceutical Quality Assurance.

    10.LYLE, Robert E. et LYLE, Gloria G. A brief history of polarimetry. 1964.