BP704TSemester 73 creditsTheory

Modern Analytical Techniques

Complete unit-wise syllabus for BP704T as per the PCI B.Pharm NEP 2020 curriculum (Semester 7 — Pharmacovigilance + Regulatory + Research).

URL:https://pharmacode.in/syllabus/semester-7/bp704t-modern-analytical-techniques/

Unit-wise Syllabus

5 Units

Thermal Analysis9 Hours

Differential Scanning Calorimetry (DSC): principle; endothermic and exothermic transitions; polymorphism, melting point, purity analysis, excipient compatibility studies
Thermogravimetric Analysis (TGA): principle, instrumentation; moisture/volatile content determination, decomposition studies; TGA-DSC hyphenated technique
Differential Thermal Analysis (DTA) and Hot Stage Microscopy: applications in pharmaceutical solid-state characterisation; glass transition temperature determination

X-ray and Electron Microscopy9 Hours

X-ray powder diffractometry (XRPD): principle; Bragg's law; diffractometer design; identification of polymorphs, crystallinity determination; amorphous vs. crystalline fraction quantification
Scanning Electron Microscopy (SEM): principle, instrumentation; sample preparation; morphology and particle size characterisation; SEM-EDX for elemental mapping of tablets
Transmission Electron Microscopy (TEM): principle; sample preparation; application in characterisation of nanoparticles, liposomes, polymeric micelles

Advanced Spectroscopic Techniques9 Hours

Nuclear Magnetic Resonance (NMR) spectroscopy: 1H and 13C NMR; 2D NMR techniques (COSY, HSQC, HMBC); structure elucidation of unknown compounds; pharmaceutical purity testing by quantitative NMR (qNMR)
Raman spectroscopy: principle; differences from IR; pharmaceutical applications — polymorphism, counterfeit drug detection, in-line monitoring; confocal Raman microscopy
NIR spectroscopy: principle; chemometric analysis; applications in non-destructive blend uniformity testing, moisture determination, active content prediction

Separation Techniques9 Hours

Capillary electrophoresis (CE): principle; capillary zone electrophoresis (CZE); micellar electrokinetic chromatography (MEKC); pharmaceutical applications — chiral separation, peptide analysis
Flow Injection Analysis (FIA): principle, manifold design; stopped-flow technique; pharmaceutical applications; sequential injection analysis (SIA)
Gel filtration, ion exchange, affinity chromatography: principles and pharmaceutical applications — protein purification, molecular weight determination

Hyphenated Techniques and Method Validation9 Hours

LC-MS and LC-MS/MS: principle; electrospray ionisation; triple quadrupole MS for quantitation (MRM mode); applications in impurity profiling, metabolite identification, bioequivalence studies
GC-MS: EI fragmentation; NIST spectral library; pharmaceutical applications — residual solvents (ICH Q3C), essential oil analysis, volatile impurity profiling
Analytical method validation as per ICH Q2(R1): parameters (specificity, linearity, range, accuracy, precision, LOD, LOQ, robustness); validation report preparation; transfer of analytical methods

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