Subject Code & Name: PY25404 – Pharmaceutical Analysis
Regulation: R-2025
Semester: IV (Fourth Semester)
Branch: B.Tech. Pharmaceutical Technology (Pharma)
Credits / L-T-P: 3 Credits | L-T-P: 3-0-0
Course Objectives
- To facilitate students to acquire knowledge about the principles and applications of pharmaceutical analysis.
Full Unit-wise Syllabus
Unit I – Online-Process Analytical Technology
On-line PAT Applications of Spectroscopy in the Pharmaceutical Industry: Reaction Monitoring - Crystallization - API Drying - Nanomilling - Hot-melt Extrusion – Granulation - Wet granulation - Roller compaction - Powder Blending - Lubrication - Powder flow - Compression – Coating - Biologics - Fermentation - Freeze- drying - Cleaning Validation.
Activities: Students analyze real or simulated process data to monitor a pharmaceutical operation (e.g., granulation or drying), identifying critical parameters using PAT tools. GD on different spectroscopy techniques (NIR, IR, Raman) to industrial applications like crystallization, blending, and coating, explaining their role in pharmaceutical R&D.
Unit II – Modern extraction methods and pharmaceutical property analysis
Strategies of sample preparation – liquid – liquid extraction, solid-liquid extraction – solid phase extraction techniques – radiometric analysis – Analysis of biological compounds – analysis of water. Solubility determination – Molecular weight determination – viscosity determination – Surface tension determination – Particle size analysis – X-ray diffraction – Polarimetery – refractometry.
Activities: Students perform or simulate sample preparation methods (liquid-liquid extraction, solid-phase extraction) and compare efficiency for isolating compounds, A group activity evaluating different analytical techniques (XRD, polarimetry, refractometry, particle size analysis), selecting appropriate methods for specific pharmaceutical samples.
Unit III – Pharmaceutical purity and quality control tests
Appearance, absorbance, pH, related substances, residual solvents, foreign anions, sulfated ash, elemental impurities, loss on drying, moisture and water, oxidizing substances, acid value, hydroxyl value, iodine value, peroxide value, saponification value, unsaponifiable matter – Functional group analysis.
Activities: Students analyze pharmaceutical samples using parameters like pH, moisture content, and absorbance, interpreting results based on pharmacopeial standards, A group activity calculating physicochemical constants (acid value, iodine value, saponification value) and relating them to drug quality and stability.
Unit IV – Validation and statistical control
Control of errors in analysis – calibration methods - Accuracy and precision – validation of analytical procedures – SOPs – compound random errors – reporting of results – terms used in the control of analytical procedures – calculations in pharmaceutical analysis: percentage, dilutions, preparation of standard stock solutions, parts per million calculations – normality – molarity – molality – analytical standards – fundamentals of statistical analysis in pharmaceutical analysis.
Activities: Students perform calculations for standard solutions (molarity, normality, ppm, dilutions), preparing stock solutions accurately, A group activity identifying sources of analytical errors and applying validation techniques (accuracy, precision, calibration), ensuring reliability of results.
Course Outcomes (COs)
- CO1: Understand the principles of Process Analytical Technology (PAT) and its role in pharmaceutical manufacturing and quality control.
- CO2: Apply appropriate sample preparation techniques for qualitative and quantitative pharmaceutical analysis.
- CO3: Apply physical analytical methods and instrumental techniques for the characterization of pharmaceutical substances and products.
- CO4: Analyze chemical analytical methods and functional group identification for pharmaceutical compounds.
- CO5: Evaluate analytical method performance through validation, quality assurance, and regulatory compliance requirements.
- CO6: Interpret analytical data and perform pharmaceutical calculations for decision-making in quality assessment and process control.
Assessment Pattern (Quick Note)
- Weightage: Continuous Assessment 40% | End Semester Examinations 60%
- Internal methodology: Assignments (20%), Solution to application-oriented problems using software (20%), Solving of GATE questions (20%), Internal Examinations (40%)
Source: Official Anna University – B.Tech. Pharmaceutical Technology R-2025 Syllabus
Last Updated: October 2026
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