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M.Pharm Pharmaceutical Analysis Syllabus

Pharmaceutical Analysis is the M.Pharm specialisation on advanced analytical techniques and the quality testing of drugs, formulations and food products. This page gives the complete syllabus of the branch as prescribed by the Pharmacy Council of India, subject by subject and unit by unit.

Source: Pharmacy Council of India (PCI), The Revised Regulations for the Master of Pharmacy Degree Program, Credit Based Semester System, and the M.Pharm syllabus prescribed by the Pharmacy Council of India. The syllabus below is reproduced from the PCI syllabus, unit by unit.

Semester 1

MPA101T Modern Pharmaceutical Analytical Techniques

Unit 1: Spectroscopy I

Unit 2: NMR spectroscopy

Quantum numbers and their role in NMR, principle, instrumentation, solvent requirement in NMR, relaxation process, NMR signals in various compounds, chemical shift, factors influencing chemical shift, spin-spin coupling, coupling constant, nuclear magnetic double resonance, brief outline of principles of FT-NMR and 13C NMR, applications of NMR spectroscopy.

Unit 3: Mass spectroscopy

Principle, theory, instrumentation of mass spectroscopy, different types of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI, analyzers of quadrupole and time of flight, mass fragmentation and its rules, metastable ions, isotopic peaks, applications of mass spectroscopy.

Unit 4: Chromatography

Principle, apparatus, instrumentation, chromatographic parameters, factors affecting resolution, isolation of drug from excipients, data interpretation and applications of: thin layer chromatography, high performance thin layer chromatography, ion exchange chromatography, column chromatography, gas chromatography, high performance liquid chromatography, ultra high performance liquid chromatography, affinity chromatography, gel chromatography.

Unit 5: Electrophoresis and X-ray crystallography

Electrophoresis: principle, instrumentation, working conditions, factors affecting separation and applications of paper electrophoresis, gel electrophoresis, capillary electrophoresis, zone electrophoresis, moving boundary electrophoresis, isoelectric focusing. X-ray crystallography: production of X rays, different X ray diffraction methods, Bragg law, rotating crystal technique, X ray powder technique, types of crystals, applications of X ray diffraction.

Unit 6: Potentiometry and thermal techniques

Potentiometry: principle, working, ion selective electrodes, applications. Thermal techniques: principle, thermal transitions and instrumentation (heat flux and power compensation designs), modulated DSC, hyper DSC, experimental parameters (sample preparation, experimental conditions, calibration, heating and cooling rates, resolution, source of errors) and their influence, advantages and disadvantages, pharmaceutical applications. Differential thermal analysis (DTA): principle, instrumentation, advantages and disadvantages, pharmaceutical applications, derivative differential thermal analysis (DDTA). TGA: principle, instrumentation, factors affecting results, advantages and disadvantages, pharmaceutical applications.

MPA102T Advanced Pharmaceutical Analysis

Unit 1: Impurity and stability studies

Impurity and stability studies: Definition, classification of impurities in drug substance or active pharmaceutical ingredients and quantification of impurities as per ICH guidelines. Impurities in new drug products: Rationale for the reporting and control of degradation products, reporting degradation products content of batches, listing of degradation products in specifications, qualification of degradation products. Impurities in residual solvents: General principles, classification of residual solvents, Analytical procedures, limits of residual solvents, reporting levels of residual solvents.

Unit 2: Elemental impurities

Elemental impurities: Element classification, control of elemental impurities, Potential Sources of elemental Impurities, Identification of Potential Elemental Impurities, analytical procedures, instrumentation & C, H, N and S analysis. Stability testing protocols: Selection of batches, container orientation, test parameters, sampling frequency, specification, storage conditions, recording of results, concept of stability, commitment etc. Important mechanistic and stability related information provided by results of study of factors like temperature, pH, buffering species ionic strength and dielectric constant etc. on the reaction rates. With practical considerations.

Unit 3: Impurity profiling and degradent characterization

Impurity profiling and degradent characterization: Method development, Stability studies and concepts of validation, accelerated stability testing & shelf life calculation, WHO and ICH stability testing guidelines, Stability zones, steps in development, practical considerations. Basics of impurity profiling and degradent characterization with special emphasis. Photostability testing guidelines, ICH stability guidelines for biological products.

Unit 4: Stability testing of phytopharmaceuticals

Stability testing of phytopharmaceuticals: Regulatory requirements, protocols, HPTLC/HPLC finger printing, interactions and complexity.

Unit 5: Biological tests and assays

Biological tests and assays of the following: a. Adsorbed Tetanus vaccine, b. Adsorbed Diphtheria vaccine, c. Human anti haemophilic vaccine, d. Rabies vaccine, e. Tetanus Anti toxin, f. Tetanus Anti serum, g. Oxytocin, h. Heparin sodium IP, i. Antivenom. PCR, PCR studies for gene regulation, instrumentation (Principle and Procedures).

Unit 6: Immunoassays (IA)

Immunoassays (IA): Basic principles, Production of antibodies, Separation of bound and unbound drug, Radioimmunoassay, Optical IA, Enzyme IA, Fluoro IA, Luminescence IA, Quantification and applications of IA.

MPA103T Pharmaceutical Validation

Unit 1: Introduction

Introduction: Definition of Qualification and Validation, Advantage of Validation, Streamlining of Qualification & Validation process and Validation Master Plan. Qualification: User Requirement Specification, Design Qualification, Factory Acceptance Test (FAT)/ Site Acceptance Test (SAT), Installation Qualification, Operational Qualification, Performance Qualification, ReQualification (Maintaining status, Calibration Preventive Maintenance, Change management), Qualification of Manufacturing Equipments, Qualification of Analytical Instruments and Laboratory equipments.

Unit 2: Qualification of analytical instruments

Qualification of analytical instruments: Electronic balance, pH meter, UV-Visible spectrophotometer, FTIR, GC, HPLC, HPTLC. Qualification of Glassware: Volumetric flask, pipette, Measuring cylinder, beakers and burette.

Unit 3: Validation of Utility systems

Validation of Utility systems: Pharmaceutical Water System & pure steam, HVAC system, Compressed air and nitrogen. Cleaning Validation: Cleaning Method development, Validation and validation of analytical method used in cleaning. Cleaning of Equipment, Cleaning of Facilities. Cleaning in place (CIP).

Unit 4: Analytical method validation

Analytical method validation: General principles, Validation of analytical method as per ICH guidelines and USP. Computerized system validation: Electronic records and digital signature, 21 CFR part 11 and GAMP 5.

Unit 5: General Principles of Intellectual Property

General Principles of Intellectual Property: Concepts of Intellectual Property (IP), Intellectual Property Protection (IPP), Intellectual Property Rights (IPR); Economic importance, mechanism for protection of Intellectual Property, patents, Copyright, Trademark; Factors affecting choice of IP protection; Penalties for violation; Role of IP in pharmaceutical industry; Global ramification and financial implications. Filing a patent applications; patent application forms and guidelines. Types patent applications, provisional and non-provisional, PCT and convention patent applications; International patenting requirement procedures and costs; Rights and responsibilities of a patentee; Practical aspects regarding maintaining of a Patent file; Patent infringement meaning and scope. Significance of transfer technology (TOT), IP and ethics, positive and negative aspects of IPP; Societal responsibility, avoiding unethical practices.

MPA104T Food Analysis

Unit 1: Carbohydrates and Proteins

Carbohydrates: classification and properties of food carbohydrates, General methods of analysis of food carbohydrates, Changes in food carbohydrates during processing, Digestion, absorption and metabolism of carbohydrates, Dietary fibre, Crude fibre and application of food carbohydrates. Proteins: Chemistry and classification of amino acids and proteins, Physico-Chemical properties of protein and their structure, general methods of analysis of proteins and amino acids, Digestion, absorption and metabolism of proteins.

Unit 2: Lipids and Vitamins

Lipids: Classification, general methods of analysis, refining of fats and oils; hydrogenation of vegetable oils, Determination of adulteration in fats and oils, Various methods used for measurement of spoilage of fats and fatty foods. Vitamins: classification of vitamins, methods of analysis of vitamins, Principles of microbial assay of vitamins of B-series.

Unit 3: Food additives

Food additives: Introduction, analysis of Preservatives, antioxidants, artificial sweeteners, flavors, flavor enhancers, stabilizers, thickening and jelling agents. Pigments and synthetic dyes: Natural pigments, their occurrence and characteristic properties, permitted synthetic dyes, Non-permitted synthetic dyes used by industries, Method of detection of natural, permitted and non-permitted dyes.

Unit 4: Milk and fermentation products

General Analytical methods for milk, milk constituents and milk products like ice cream, milk powder, butter, margarine, cheese including adulterants and contaminants of milk. Analysis of fermentation products like wine, spirits, beer and vinegar.

Unit 5: Pesticide analysis

Pesticide analysis: Effects of pest and insects on various food, use of pesticides in agriculture, pesticide cycle, organophosphorus and organochlorine pesticides analysis, determination of pesticide residues in grain, fruits, vegetables, milk and milk products. Legislation regulations of food products with special emphasis on BIS, Agmark, FDA and US-FDA.

Practicals and Seminar

Semester 2

MPA201T Advanced Instrumental Analysis

Unit 1: HPLC

HPLC: Principle, instrumentation, pharmaceutical applications, peak shapes, capacity factor, selectivity, plate number, plate height, resolution, band broadening, pumps, injector, detectors, columns, column problems, gradient HPLC, HPLC solvents, trouble shooting, sample preparation, method development, New developments in HPLC, role and principles of ultra, nano liquid chromatography in pharmaceutical analysis. Immobilized polysaccharide CSPs: Advancement in enantiomeric separations, revised phase Chiral method development and HILIC approaches. HPLC in Chiral analysis of pharmaceuticals. Preparative HPLC, practical aspects of preparative HPLC.

Unit 2: Biochromatography

Biochromatography: Size exclusion chromatography, ion exchange chromatography, ion pair chromatography, affinity chromatography, general principles, stationary phases and mobile phases. Gas chromatography: Principles, instrumentation, derivatization, head space sampling, columns for GC, detectors, quantification. High performance Thin Layer chromatography: Principles, instrumentation, pharmaceutical applications.

Unit 3: Super critical fluid chromatography and Capillary electrophoresis

Super critical fluid chromatography: Principles, instrumentation, pharmaceutical applications. Capillary electrophoresis: Overview of CE in pharmaceutical analysis, basic configuration, CE characteristics, principles of CE, methods and modes of CE. General considerations and method development in CE, Crown ethers as buffer additives in capillary electrophoresis. CE-MS hyphenation.

Unit 4: Mass spectrometry

Mass spectrometry: Principle, theory, instrumentation of mass spectrometry, different types of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI, APPI, mass fragmentation and its rules, meta stable ions, isotopic peaks and applications of mass spectrometry. LC-MS hyphenation and DART MS analysis. Mass analysers (Quadrupole, Time of flight, FTICR, ion trap and Orbitrap) instruments. MS/MS systems (Tandem: QqQ, TOF-TOF, Q-IT, Q-TOF, LTQ-FT, LTQ-Orbitrap).

Unit 5: NMR spectroscopy

NMR spectroscopy: Quantum numbers and their role in NMR, Principle, Instrumentation, Solvent requirement in NMR, Relaxation process, NMR signals in various compounds, Chemical shift, Factors influencing chemical shift, Spin-Spin coupling, Coupling constant, Nuclear magnetic double resonance, Brief outline of principles of FT-NMR with reference to 13C NMR: Spin spin and spin lattice relaxation phenomenon. 13C NMR, 1-D and 2-D NMR, NOESY and COSY techniques, Interpretation and Applications of NMR spectroscopy. LC-NMR hyphenations.

MPA202T Modern Bio-Analytical Techniques

Unit 1: Extraction of drugs and metabolites from biological matrices

Extraction of drugs and metabolites from biological matrices: General need, principle and procedure involved in the Bioanalytical methods such as Protein precipitation, Liquid-Liquid extraction and Solid phase extraction and other novel sample preparation approach. Bioanalytical method validation: USFDA and EMEA guidelines.

Unit 2: Biopharmaceutical Consideration

Biopharmaceutical Consideration: Introduction, Biopharmaceutical Factors Affecting Drug Bioavailability, In Vitro: Dissolution and Drug Release Testing, Alternative Methods of Dissolution Testing, Transport models, Biopharmaceutics Classification System. Solubility: Experimental methods. Permeability: In-vitro, in-situ and In-vivo methods.

Unit 3: Pharmacokinetics and Toxicokinetics

Pharmacokinetics and Toxicokinetics: Basic consideration, Drug interaction (PK-PD interactions), The effect of protein-binding interactions, The effect of tissue-binding interactions, Cytochrome P450-based drug interactions, Drug interactions linked to transporters. Microsomal assays. Toxicokinetics, Toxicokinetic evaluation in preclinical studies, Importance and applications of toxicokinetic studies. LCMS in bioactivity screening and proteomics.

Unit 4: Cell culture techniques

Cell culture techniques: Basic equipments used in cell culture lab. Cell culture media, various types of cell culture, general procedure for cell cultures; isolation of cells, subculture, cryopreservation, characterization of cells and their applications. Principles and applications of cell viability assays (MTT assays), Principles and applications of flow cytometry.

Unit 5: Metabolite identification

Metabolite identification: In-vitro / in-vivo approaches, protocols and sample preparation. Microsomal approaches (Rat liver microsomes (RLM) and Human liver microsomes (HLM)) in Met-ID. Regulatory perspectives. In-vitro assay of drug metabolites & drug metabolizing enzymes. Drug Product Performance, In Vivo: Bioavailability and Bioequivalence: Drug Product Performance, Purpose of Bioavailability Studies, Relative and Absolute Availability. Methods for Assessing Bioavailability, Bioequivalence Studies, Design and Evaluation of Bioequivalence Studies, Study Designs, Crossover Study Designs, Generic Biologics (Biosimilar Drug Products), Clinical Significance of Bioequivalence Studies.

MPA203T Quality Control and Quality Assurance

Unit 1: Concept and Evolution of Quality Control and Quality Assurance

Concept and Evolution of Quality Control and Quality Assurance. Good Laboratory Practice, GMP, Overview of ICH Guidelines, QSEM, with special emphasis on Q-series guidelines. Good Laboratory Practices: Scope of GLP, Definitions, Quality assurance unit, protocol for conduct of non clinical testing, control on animal house, report preparation and documentation.

Unit 2: cGMP guidelines

cGMP guidelines according to schedule M, USFDA (inclusive of CDER and CBER) Pharmaceutical Inspection Convention (PIC), WHO and EMEA covering: Organization and personnel responsibilities, training, hygiene and personal records, drug industry location, design, construction and plant lay out, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination and Good Warehousing Practice. CPCSEA guidelines.

Unit 3: Analysis of raw materials, finished products and packaging materials

Analysis of raw materials, finished products, packaging materials, in process quality control (IPQC), Developing specification (ICH Q6 and Q3). Purchase specifications and maintenance of stores for raw materials. In process quality control and finished products quality control for following formulation in Pharma industry according to Indian, US and British pharmacopoeias: tablets, capsules, ointments, suppositories, creams, parenterals, ophthalmic and surgical products (How to refer pharmacopoeias), Quality control test for containers, closures and secondary packing materials.

Unit 4: Documentation in pharmaceutical industry

Documentation in pharmaceutical industry: Three tier documentation, Policy, Procedures and Work instructions, and records (Formats), Basic principles, How to maintain, retention and retrieval etc. Standard operating procedures (How to write), Master Formula Record, Batch Formula Record, Quality audit plan and reports. Specification and test procedures, Protocols and reports. Distribution records. Electronic data.

Unit 5: Manufacturing operations and controls

Manufacturing operations and controls: Sanitation of manufacturing premises, mix-ups and cross contamination, processing of intermediates and bulk products, packaging operations, IPQC, release of finished product, process deviations, charge-in of components, time limitations on production, drug product inspection, expiry date calculation, calculation of yields, production record review, change control, sterile products, aseptic process control, packaging.

MPA204T Herbal and Cosmetic Analysis

Unit 1: Herbal remedies, Toxicity and Regulations

Herbal remedies, Toxicity and Regulations: Herbals vs Conventional drugs, Efficacy of herbal medicine products, Validation of Herbal Therapies, Pharmacodynamic and Pharmacokinetic issues. Herbal drug standardization: WHO and AYUSH guidelines.

Unit 2: Adulteration and Deterioration

Adulteration and Deterioration: Introduction, types of adulteration/substitution of herbal drugs, Causes and Measure of adulteration, Sampling Procedures, Determination of Foreign Matter, DNA Finger printing techniques in identification of drugs of natural origin, heavy metals, pesticide residues, phytotoxin and microbial contamination in herbal formulations. Regulatory requirements for setting herbal drug industry: Global marketing management, Indian and international patent law as applicable herbal drugs and natural products and its protocol.

Unit 3: Testing of natural products and drugs

Testing of natural products and drugs: Effect of herbal medicine on clinical laboratory testing, Adulterant Screening using modern analytical instruments, Regulation and dispensing of herbal drugs, Stability testing of natural products, protocol. Monographs of Herbal drugs: Study of monographs of herbal drugs and comparative study in IP, USP, Ayurvedic Pharmacopoeia, American herbal Pharmacopoeia, British herbal Pharmacopoeia, Siddha and Unani Pharmacopoeia, WHO guidelines in quality assessment of herbal drugs.

Unit 4: Herbal drug-drug interaction

Herbal drug-drug interaction: WHO and AYUSH guidelines for safety monitoring of natural medicine, Spontaneous reporting schemes for bio drug adverse reactions, bio drug-drug and bio drug-food interactions with suitable examples. Challenges in monitoring the safety of herbal medicines.

Unit 5: Evaluation of cosmetic products

Evaluation of cosmetic products: Determination of acid value, ester value, saponification value, iodine value, peroxide value, rancidity, moisture, ash, volatile matter, heavy metals, fineness of powder, density, viscosity of cosmetic raw materials and finished products. Study of quality of raw materials and general methods of analysis of raw material used in cosmetic manufacture as per BIS. Indian Standard specification laid down for sampling and testing of various cosmetics in finished forms such as baby care products, skin care products, dental products, personal hygiene preparations, lip sticks. Hair products and skin creams by the Bureau of Indian Standards.

Practicals and Seminar

Semester 3 and 4

Semester 3 and Semester 4 are common to all M.Pharm specialisations: Research Methodology and Biostatistics (MRM301T), Journal Club, Discussion / Presentation and Research Work. See the M.Pharm common syllabus page for the full common syllabus.