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    Faculty : Science and Technology
     Department: process engineering
     Target public: 1st Master                                
     Fields of Specialization: pharmaceutical engineering
    Course title: Drug Analysis and control
     Credit: 4
     Coefficient: 2
     Duration: 15 weeks
     Weekly timetable: 1h 30 min of course and 1h 30 min of tutorial
     Place of teaching: classroom 22 (block 1)
     Prof: S. Ikhlef
     Contact: s.ikhlef@centre-univ-mila.dz
     Availability: every Munday from 9.30am-11am in office 19 (block 4).
     Evaluation methods:  A final exam 60%, interogation 40%,
     Responses by e-mail: I promise to reply by e-mail within 24 hours of receiving the message, except in the case of unexpected circumstances.

    • Target Skills

       2

      By the end of this course, students will be able to:

      1. Understand regulatory frameworks and pharmacopoeial standards related to drug quality and control.

      2. Design and implement appropriate analytical strategies for identification, assay, and impurity testing.

      3. Apply major analytical techniques (chromatographic, spectroscopic, and titrimetric methods).

      4. Perform quality control tests for raw materials, finished products, sterile, biotechnological, and chiral medicines.

      5. Evaluate drug stability and degradation mechanisms.

      6. Apply pharmaceutical quality system principles, including GMP, risk management, Quality by Design, and method validation.

      7. Interpret analytical results and prepare technical documentation for regulatory compliance and marketing authorization.

       

      • Prerequisites

        4

        Prerequisites

        Students should have prior knowledge of:

        1. General Chemistry (acid-base, redox, kinetics).

        1. Organic Chemistry (functional groups, stereochemistry, degradation reactions).

        2. Analytical Chemistry (titration, spectroscopy, chromatography basics).

        3. Physical Chemistry (pH, solubility, thermodynamics basics).

        4. Pharmaceutical Technology basics (dosage forms).

        5. Basic understanding of statistics (mean, standard deviation, calibration curve).

        6. Basic understanding of statistics (mean, standard deviation, calibration curve).


        • Chapter N° 1

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