R19M PharmPharmaceuticalAnalysisISem
R19M PharmPharmaceuticalAnalysisISem
R19M PharmPharmaceuticalAnalysisISem
I YEAR I Semester
Course Code Course Title L T P Credits
Professional Modern Pharmaceutical Analytical Techniques 3 0 0 3
Core-I
Professional Pharmaceutical and Food Analysis 3 0 0 3
Core-II
Professional 1. Advanced Pharmaceutical Analysis 3 0 0 3
Elective-I 2. Drug Regulatory Affairs
3. Phytochemistry
Professional 1. Quality control and Quality Assurance 3 0 0 3
Elective-II 2. Cosmetics and Cosmeceuticals
3. Stability of Drugs and Dosage forms
MC Research Methodology & Intellectual Property Rights 2 0 0 2
Laboratory-I Modern Pharmaceutical Analytical Techniques lab 0 0 4 2
Laboratory-II Pharmaceutical and food Analysis Lab 0 0 4 2
Audit Audit course- I 2 0 0 0
TOTAL 16 0 8 18
I YEAR II Semester
Course Code Course Title L T P Credits
Professional Advanced Instrumental Analysis I 3 0 0 3
Core-III
Professional Modern Bio-analytical Techniques 3 0 0 3
Core-IV
Professional 1. Pharmaceutical Validation 3 0 0 3
Elective-III 2. Herbal Cosmetics
3. Pharmacoepidemology and Pharmacoeconomics
Professional 1. Advanced Instrumental Analysis - II 3 0 0 3
Elective-IV 2. Nutraceuticals
3. Clinical Research and Pharmacovigilance
Laboratory-III Advanced Instrumental Analysis I Lab 0 0 4 2
Laboratory-IV Modern Bio analytical Techniques Lab 0 0 4 2
-- Mini Project with Seminar 2 0 0 2
Audit Audit Course- II 2 0 0 0
TOTAL 16 0 8 18
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
Course Objective: The course is designed to impart the knowledge in the field of Pharmaceutical
Analysis. The various modern analytical techniques like UV-Visible, IR, NMR, Mass, GC, HPLC,
different chromatographic methods and other important topics are taught to enable the students to
understand and apply the principles involved in the determination of different bulk drugs and their
formulation. In addition to the theoretical aspects, the basic practical knowledge relevant to the
analysis is also imparted.
Course Outcome: The appreciable knowledge will be gained by the students in the Modern
Analytical Techniques and can apply the theories in the Analysis of various bulk drugs and their
formulations. The students will also be in a position to apply their knowledge in developing the new
methods for the determination and validate the procedures.
UNIT I
Introduction to chromatography and classification of chromatographic methods based on the
mechanism of separation
a. Column Chromatography: Adsorption and partition, theory, preparation, procedure and methods
of detection
b. Thin Layer Chromatography: Theory, preparation, procedures, detection of compounds
c. Paper Chromatography: Theory, different techniques employed, filter papers used, qualitative and
quantitative detection
d. Counter – current extraction, solid phase extraction techniques, gel filtration
UNIT II
a. Gas chromatography: Introduction, fundamentals, instrumentation, columns: preparation and
operation, detection, derivatization.
b. HPLC: Basic parameters, Principles and instrumentation, solvents and columns used,
Operational modes, detection and applications of HPLC
c. HPTLC: Theory and principle, instrumentation, elution techniques and pharmaceutical
applications
UNIT III
a. UV-Visible spectroscopy: Introduction, electromagnetic spectrum, absorbance laws and
limitations, instrumentation-design and working principle, chromophore concept, auxochromes,
Wood-Fisher rules for calculating absorption maximum, applications of UV-Visible spectroscopy
b. IR spectroscopy: Basic principles -Molecular vibrations, vibrational frequency, factors influencing
vibrational frequencies, sampling techniques, instrumentation, interpretation of spectra, FT-IR,
theory and applications
UNIT IV
Mass spectroscopy: Theory, ionization techniques: electron impact ionization, chemical ionization,
field ionization, fast atom bombardment, plasma desorption, fragmentation process: types of fission,
resolution, GC/MS and applications for identification and structure determination.
UNIT V
NMR: Theory, instrumentation, chemical shift, shielding and deshielding effects, splitting of signals,
spin-spin coupling, proton exchange reactions, coupling constant(J), nuclear overhauser effect (NOE),
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CNMR spectra and its applications, 2D-NMR, COSY and applications in pharmacy.
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
REFERENCES:
1. Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma Principles of Instrumental Analysis - Doglas A Skoog,
F. James Holler, Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
4. A Text book of Pharmaceutical Analysis by Kerrenth A. Connors
5. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
6. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
7. Organic Chemistry by I. L. Finar
8. Organic spectroscopy by William Kemp
9. Quantitative Analysis of Drugs by D. C. Garrett
10. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
11. Spectrophotometric identification of Organic Compounds by Silverstein
12. HPTLC by P.D. Seth
13. Indian Pharmacopoeia 2007
14. High Performance thin layer chromatography for the analysis of medicinal plants by Eike
Reich, Anne Schibli
15. Introduction to instrumental analysis by Robert. D. Braun
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
Course Objective: This course is designed to impart knowledge on analysis of food constituents and
finished food products. The course includes application of instrumental analysis in the determination
of pesticides in variety of food products.
Course Outcome: At completion of this course student shall be able to understand various analytical
techniques in the determination of
Food constituents
Food additives
Finished food products
Pesticides in food
Pharmaceuticals (API & Dosage forms)
And also student shall have the knowledge on food regulations and legislations
UNIT I
a. Carbohydrates: Classification and properties of food carbohydrates, General methods of
analysis of food carbohydrates,
b. 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
UNIT II
a. Lipids: Classification, general methods of analysis, refining of fats and oils; hydrogenation of
vegetable oils, Determination of adulteration in fats and oils.
UNIT II
Definition, classification and principles and procedures involved in the quantitative determination of
drugs from each category of both API and dosage forms (IP) of the following
a. Alkaloids b. Antibiotics c. Diuretics
UNIT IV
Definition, classification and principles and procedures involved in the quantitative determination of
drugs from each category of both API and dosage forms (IP) of the following
a. Analgesics & Antipyretics b. Antihypertensives
c. Antihistamines
UNIT V
a. General Analytical methods for milk, milk constituents and milk products like ice cream, milk
powder, butter, margarine, cheese including adulterants and contaminants of milk.
TEXT BOOKS
1. The chemical analysis of foods – David Pearson, Seventh edition, Churchill Livingstone,
Edinburgh London, 1976
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
2. Introduction to the Chemical analysis of foods – S. Nielsen, Jones & Bartlett publishers,
Boston London, 1994.
3. Official methods of analysis of AOAC International, sixth edition, Volume I & II, 1997.
4. Pharmaceutical Analysis – Higuchi. T
5. Analysis of Food constituents – Multon, Wiley VCH.
6. Dr. William Horwitz, Official methods of analysis of AOAC International
7. 18th edition, 2005.Theory and Practice of Industrial Pharmacy by Lieberman and Lachman
REFERENCE BOOKS
1. Remington’s Pharmaceutical Sciences by Alfonso and Gennaro
th
2. David Pearson. The Chemical Analysis of Foods, 7 ed., Churchill Livingstone, Edinburgh,
1976.
3. Nielsen S. Introduction to the chemical analysis of foods. Jones & Bartlett Publishers, Boston,
1974
4. Indian Pharmacopoeia 2012
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
Course Objective: The principles and procedures for the determination of various pharmaceutical
bulk drugs and their formulations belonging to different categories are discussed in detail. The
applications of the important reagents like MBTH, FC, PDAB etc. in the determination of the
pharmaceuticals are also discussed.
UNIT I
Principles and procedures involved in the determination of the official compounds in IP with the
following analytical techniques
A. Non-aqueous C. Complexometric
B. Oxidation-reduction D. Diazotization methods
E. Neutralization F. Acid – Base
UNIT II
A detailed study of the principles and procedures involved in the quantitative determination of the
following organic functional groups
A. Amines C. Carbonyl compounds
B. Esters D. Hydroxy and carboxyl
E. Amino Acids
UNIT III
a. Reference Standards: Types, preparation methods and uses.
b. Principles and procedures involved in using the following reagents in the determination of
pharmaceutical dosage forms official in IP
a. MBTH (3-methyl-2-benzothiazolone hydrazone)
b. F.C. Reagent (Folin-Ciocalteu)
c. PDAB (para-Dimethyl Amino Benzaldehyde)
d. 2, 3, 5 - triPhenyltetrazolium salt
e. 2,6 di -ChloroquinoneChlorimide
f. N - (1-naphthyl) ethylenediaminedihydrochloride (B.M. Reagent)
g. Carr – Price Reagent
h. 2,4 - DNP
UNIT - IV
a. Analysis of Excipients: Tests related to excipients such as bulk density, tapped density, particle
size distribution, pH, moisture content, viscosity (dynamic), loss on drying, ash content,
conductivity.
b. Excipients of interest: Disintegrating agents, binders, emulsifiers, viscosity modifiers and
preservatives including preservative challenge test.
UNIT-V
a. Dissolution Tests: Types of Dissolution apparatus, dissolution test requirements for immediate
release, delayed release, extended release dosage forms, coated, uncoated, enteric coated,
gelatin capsules etc.
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
b. Microbiological assays and Biological tests: Antimicrobial effectiveness testing, microbial limit
tests, sterility test. Antibiotics-microbial assays, bacterial endotoxins test.
TEXT BOOKS:
1. Pharmaceutical Chemistry by Becket and Stanlake
2. Pharmaceutical Analysis by Higuchi, Bechmman and Hassan
3. Instrumental Methods of Chemical Analysis By B.K. Sharma
4. A Text Book of Pharmaceutical Analysis by Kennenth A. Conners
5. Organic spectroscopy by Y.R Sharma Principles of Instrumental Analysis - Doglas A Skoog,
F. James Holler, Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
6. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.
REFERENCES:
1. Remington’s Pharmaceutical Sciences by Alfonso and Gennaro
2. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P.D. Sethi
3. Indian Pharmacopoeia 2010
4. Journals (Indian Drugs, IJPS etc.)
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
Course Objective: The topics which are present in the Drug regulatory affairs are very much useful
which increases the knowledge regarding the regulatory aspects in the pharmaceutical industries.
Course Outcome:
Students will come to know the different competent regulatory authorities globally.
Students be aware of technical aspects pertaining to the marketing authorization application
(MAA)
The regulatory guidelines and directions framed by the regulatory authorities will be helpful to
place the drug products in market for marketing approvals.
UNIT I
Drug Regulatory Aspects (India)
1. Indian drug regulatory authorities, Central and State regulatory bodies (FDA)
2. Drugs and Cosmmetics Act and Rules with latest Amendments (Selective)
3. Special emphasis – Schedule M and Y
4. New drugs – Importation, Registration, development, Clinical Trials, BE NOC & BE studies
5. Various Licences – Test Lic., Import lic., for testing of drugs and API’s, Manufacturing Contract
and Loan licence manufacturing.
UNIT II
Good Manufacturing Practices (GMP)
1. Indian GMP certification, WHO GMP certification.
2. ICH guidelines for stability testing and other relevant ones (Q1-Q10)
3. Export permissions and manufacturing for semi-regulated countries
4. Understanding of the plant layouts with special emphasis on the environment & safety (HVAC,
Water Systems, Stores Management, Effluent etc.)
5. Quality Assurance and Qulaity Control – Basic understanding for in-built quality.
UNIT III
A detailed study of regulatory aspects that affect drug product design, manufacture and distribution in
a developed country such as USA and in a developing country such as Brazil, Hatch Waxmann Act;
Bolar Provisions and other FDA Regulations. Regulatory aspects of pharmaceutical and bulk drug
manufacture, regulatory drug analysis.
UNIT IV
Documentation related to manufacturing, cleaning methods, retention samples and records, quality
control, batch release documents, distribution records, complaints and recalls.
Quality, safety and legislation for cosmetic products and herbal products.
UNIT V
Governing Regulatory Bodies across the globe.
Country Authority Submission
a. U.S Food & Drug Administration USDMF
b. Canada Therapeutic Product Directorate DMF
c. Europe
1) European Medicines Agency (EMEA/ National Authorities) EDMF
2) European Directorate for Quality of Medicines CEP/COS & Health Care Products.
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
Course Objective: Helps the students to get exposed to natural product drug discovery and to
perform quantitative and qualitative evaluation of herbal extracts. To understand the chemistry of
important phyto consitituents of different categories.
Course Outcome: On the basis of chemistry data of phytoconstituents students will acquire
knowledge on various types of phytoconstituents present in the plants.
UNIT I
Biosynthetic pathways and Radio tracing techniques: containing drugs:
a) Methods of Biogenetic Investigations, detailed study of isotropic tracer techniques.
b) Study of Biosynthetic pathways of of following phyto-pharmaceuticals: Atropine, Morphine,
Cardiac glycosides and Flavonoids.
UNIT II
Drug discovery and development: Approaches to discovery and development of natural products as
potential new drugs. Sourcing and archiving Natural products for discovery, evaluating natural
products for therapeutic properties, Identifying the biologically active Natural products, the lead
structure selection process and Optimization with suitable examples from the following source:
artemesin, andrographolides.
UNIT III
a) Extraction/Isolation methods for specific Phytochemical groups, Choice of solvents and Interfering
compounds for general Isolation and purification of desired phytoconstituents.
b) Recent sophisticated extraction techniques like: Super critical fluid extraction and Ultra-sonic
extraction. Separation of phytoconstituents by Vacuum and Flash column chromatography.
UNIT IV
Sources, Chemical structure, Identification tests, mechanism of action SAR, uses of the following
phyto-pharmaceuticals:
a) Atropine, caffeine, Morphine and brief account on its derivatives and analogues
b) Camptothecin, Digoxin
c) Taxol, Podophyllotoxin
UNIT V
a. Natural colorants: Biological Source, colouring principles, chemical nature and usage of the
following Annatto, Cochineal, Caramel, Henna, Indigo, Madder, Saffron, Turmeric
b. Flavours and Perfumes: Sandal wood oil, Orange oil, Lemon oil, Palmarosa oil, Geranium oil.
Reference books
1. Phytochemical methods of chemical analysis by Harbone
2. Modern methods of plant analysis- peach & M.V. Tracey Vol. 1 to VII
3. Pharmacognosy & Phytochemistry of medical plants by Jean Brunton
4. Thin layer chromatography by Stahl
5. Chemistry of natural products by Atur Rahman
6. Comprehensive Medicinal Chemistry, Vol 1-6, Elsevier Publication
7. Medicinal Chemistry Drug Discovery by Donald J, Abrahm,
8. Plant drug analysis by Wagner
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
Course Objective: This course deals with the various aspects of quality control and quality
assurance aspects of pharmaceutical industries. It covers the important aspects like cGMP, QC tests,
documentation, quality certifications, GLP and regulatory affairs.
Course Outcome: Upon completion of this course the student should be able to
Understand the cGMP aspects in a pharmaceutical industry
To appreciate the importance of documentation
To understand the scope of quality certifications applicable to
Pharmaceutical industries
To understand the responsibilities of QA & QC departments.
UNIT – I
Introduction: Concept and evolution and scopes of Quality Control and Quality Assurance, Good
Laboratory Practice, GMP, Overview of ICH Guidelines - QSEM, with special emphasis on Qseries
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.
CPCSEA guidelines.
UNIT - II
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.
UNIT - III
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 dosage forms in
Pharma industry according to Indian, US and British pharmacopoeias: tablets, capsules, ointments,
suppositories, creams, parenterals, ophthalmic and surgical products (How to refer pharmacopoeias).
UNIT - IV
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 Batch Record, Batch Manufacturing Record,
Quality audit plan and reports. Specification and test procedures, Protocols and reports. Distribution
records. Electronic data handling. Concepts of controlled and uncontrolled documents. Submission
documents for regulators DMFs, as Common Technical Document and Electronic Common Technical
Documentation (CTD, eCTD). Concept of regulated and non-regulated markets.
UNIT - V
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, reprocessing, salvaging, handling of
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
waste and scrap disposal. Introduction, scope and importance of intellectual property rights. Concept
of trade mark, copyright and patents.
REFERENCE BOOKS:
1. Quality Assurance Guide by organization of Pharmaceutical Procedures of India, 3rd
revised edition, Volume I & II, Mumbai, 1996.
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69, Marcel
Dekker Series, 1995.
3. Quality Assurance of Pharmaceuticals- A compedium of Guide lines and Related materials
Vol I & II, 2nd edition, WHO Publications, 1999.
4. How to Practice GMP’s – P P Sharma, Vandana Publications, Agra, 1991.
5. The International Pharmacopoeia – vol I, II, III, IV & V - General Methods of Analysis and
Quality specification for Pharmaceutical Substances, Excepients and Dosage forms, 3rd
edition, WHO, Geneva, 2005.
6. Good laboratory Practice Regulations – Allen F. Hirsch, Volume 38, Marcel Dekker Series,
1989.
7. ICH guidelines
8. ISO 9000 and total quality management
9. The drugs and cosmetics act 1940 – Deshpande, Nilesh Gandhi, 4th edition, Susmit
Publishers, 2006.
10. QA Manual – D.H. Shah, 1st edition, Business Horizons, 2000.
11. Good Manufacturing Practices for Pharmaceuticals a plan for total quality control – Sidney
H. Willig, Vol. 52, 3rd edition, Marcel Dekker Series.
12. Steinborn L. GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their
Suppliers, Sixth Edition, (Volume 1 - With Checklists and
13. Software Package). Taylor & Francis; 2003.
14. Sarker DK. Quality Systems and Controls for Pharmaceuticals. John Wiley & Sons; 2008.
15. Packaging of Pharmaceuticals.
16. Schedule M and Schedule N.
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
Course Objectives: Upon completion of the course, the students shall be able to understand
Key ingredients used in cosmetics and cosmeceuticals.
Key building blocks for various formulations.
Current technologies in the market
Various key ingredients and basic science to develop cosmetics and cosmeceuticals
Scientific knowledge to develop cosmetics and cosmeceuticals with desired Safety, stability,
and efficacy.
Course Outcomes: Upon completion of the subject student shall able to know Regulatory biological
aspects of cosmetics, excipients used for various formulations, designing of cosmeceuticals and
herbal products
UNIT I
Cosmetics – Regulatory: Definition of cosmetic products as per Indian regulation. Indian regulatory
requirements for labeling of cosmetics Regulatory provisions relating to import of cosmetics.
Misbranded and spurious cosmetics. Regulatory provisions relating to manufacture of cosmetics –
Conditions for obtaining license, prohibition of manufacture and sale of certain cosmetics, loan
license, offences and penalties.
UNIT II
Cosmetics - Biological aspects: Structure of skin relating to problems like dry skin, acne,
pigmentation, prickly heat, wrinkles and body odor. Structure of hair and hair growth cycle. Common
problems associated with oral cavity. Cleansing and care needs for face, eye lids, lips, hands, feet,
nail, scalp, neck, body and under-arm.
UNIT III
Formulation Building blocks: Building blocks for different product formulations of
cosmetics/cosmeceuticals. Surfactants – Classification and application. Emollients, rheological
additives: classification and application. Antimicrobial used as preservatives, their merits and
demerits. Factors affecting microbial preservative efficacy. Building blocks for formulation of a
moisturizing cream, vanishing cream, cold cream, shampoo and toothpaste. Soaps and syndetbars.
Perfumes; Classification of perfumes. Perfume ingredients listed as allergens in EU regulation.
Controversial ingredients: Parabens, formaldehyde liberators, dioxane.
UNIT IV
Design of cosmeceutical products: Sun protection, sunscreens classification and regulatory
aspects. Addressing dry skin, acne, sun-protection, pigmentation, prickly heat, wrinkles, body odor.,
dandruff, dental cavities, bleeding gums, mouth odor and sensitive teeth through cosmeceutical
formulations.
UNIT V
Herbal Cosmetics: Herbal ingredients used in Hair care, skin care and oral care. Review of
guidelines for herbal cosmetics by private bodies like cosmos with respect to preservatives,
emollients, foaming agents, emulsifiers and rheology modifiers. Challenges in formulating herbal
cosmetics.
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
REFERENCES
1. Harry’s Cosmeticology. 8th edition.
2. Poucher’s perfume cosmetics and Soaps, 10th edition.
3. Cosmetics - Formulation, Manufacture and quality control, P. P. Sharma, 4th edition
4. Handbook of cosmetic science and Technology A.O. Barel, M. Paye and H.I. Maibach. 3 rd
edition
5. Cosmetic and Toiletries recent suppliers’ catalogue.
6. CTFA directory.
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
Course Objective: These topics are designed impart a specialized knowledge to preserve the
properties of drugs and dosage forms during manufacture storage and shelf life. The understanding of
properties and evaluation of stability during storage, by solution and solid state against several factors
of degradation.
Course Outcome: The students should describe the evaluation of stability of solutions, solids and
formulations against adverse conditions. The students should be able to suggest the measures to
retain stability and storage conditions for retaining the efficacy of the products.
UNIT - I
Drug decomposition mechanisms:
1. Hydrolysis and acyltransfers: Nature of reaction, structure and utility, stabilization of
Pharmaceutical examples.
2. Oxidation: Nature of oxidation, kinetics of oxidation, oxidation pathways of pharmaceutical,
Interest Inhibition of oxidation
3. Photolysis: Energetics of photolysis, kinetics photolysis, photolytic reactions of
pharmaceutical interest, prevention of photolytic reactions.
UNIT - II
Solid state chemical decomposition: Kinetic of solids state decomposition, Pharmaceutical examples
of solid-state decomposition, Pure drugs, drug excipient and drug-drug interaction in solid state,
methods of stabilization.
Physical stability testing of dosage forms:
1. Solids – tablets, capsules, powder and granules
2. Disperse systems
3. Microbial decomposition
4. Over-view, physical stability of novel drug carriers, liposomes, niosomes, nano-particles.
UNIT - III
Identification and quantitative determination of preservatives, Antioxidants, colouring materials,
emulsifiers and stabilizers in Pharmaceutical formulation.
Analysis of drugs from biological samples including, selection of biological sample, extraction of drugs
by various methods as LLE, SPE and Membrane filtration. Factors affecting extraction of drugs.
UNIT - IV
General method of analysis to determine the quality of raw materials used in cosmetic industry. Indian
Standard Specifications (ISI) laid down for sampling and testing of various cosmetics in finished form
by the Bureau of Indian Standards.
UNIT - V
Methods of analysis to determine the quality of cosmetics in the finished forms such as Hair care
products, Skin care products, Baby care products, Dental products, Personal hygiene products,
Colour cosmetics, Ethnic products, Colour makeup preparation, Lipsticks, Hair setting lotions and Eye
shadows. Toxicity testing in cosmetics and Safety and Legislation of Cosmetic products.
Stability studies: Concept of stability studies.
a) cGMP& ICH guidelines for Accelerated stability Testing.
b) Interaction of containers & closure Compatibility Testing.
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
REFERENCE BOOKS:
1. Comprehensive Pharmacy Review 5th Edition by Leon Shargel, Alan H. Mutnick, Paul F.
Souney, Larry N. Sawnson – 2004.
2. A. H. Beckett and J. B. Stenlake Practical Pharmaceutical Chemistry, Part I and Part II, 4th
Edition. 3. G. H. Jeffery, J. Basset, J. Mendham, R. C. Denny (Rev. by) Vogels Text Book of
Quantitative Chemical Analysis, 5th Edition 1989, ELBS.
3. The Controller of Publications; New Delhi, Govt. of India, Indian Pharmacopoeia, Vol. I and
Vol. II - 2010.
4. J. B. Wilkinson and R. J. Moore, Herry’s Cosmeticology; Longman Scientific and Technical
Publishers, Singapore.
5. P.D. Sethi; Quantitative Analysis of Drugs in Pharmaceutical Formulations, 3rd Edition - 1997,
6. Classification of cosmetics raw materials and adjuncts IS 3958 of Indian Standards Institution
(BIS).
7. Cosmetic and toilet goods – methods of sampling IS 3958 of Indian Standards Institution
(BIS).
8. Methods of sampling and test for various cosmetics as laid down by Bureau of Indian
Standards.
9. Drug stability: Principles and practices by Jens T. Carstensen
10. Stability Testing of Drug Products by W. Grimm. 12. Stability of Drugs and Dosage Forms by
Yoshioka and Stella.
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
Course Objectives:
To understand the research problem
To know the literature studies, plagiarism and ethics
To get the knowledge about technical writing
To analyze the nature of intellectual property rights and new developments
To know the patent rights
UNIT - I
Meaning of research problem, Sources of research problem, Criteria Characteristics of a good
research problem, Errors in selecting a research problem, Scope and objectives of research problem.
Approaches of investigation of solutions for research problem, data collection, analysis, interpretation,
Necessary instrumentations
UNIT - II
Effective literature studies approaches, analysis, Plagiarism, Research ethics
UNIT - III
Effective technical writing, how to write report, Paper Developing a Research Proposal, Format of
research proposal, a presentation and assessment by a review committee
UNIT - IV
Nature of Intellectual Property: Patents, Designs, Trade and Copyright. Process of Patenting and
Development: technological research, innovation, patenting, development. International Scenario:
International cooperation on Intellectual Property. Procedure for grants of patents, Patenting under
PCT.
UNIT - V
Patent Rights: Scope of Patent Rights. Licensing and transfer of technology. Patent information
and databases. Geographical Indications. New Developments in IPR: Administration of Patent
System. New developments in IPR; IPR of Biological Systems, Computer Software etc. Traditional
knowledge Case Studies, IPR and IITs.
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
TEXT BOOKS:
1. Stuart Melville and Wayne Goddard, “Research methodology: an introduction for science
& engineering students’”
2. Wayne Goddard and Stuart Melville, “Research Methodology: An Introduction”
REFERENCES:
1. Ranjit Kumar, 2nd Edition, “Research Methodology: A Step by Step Guide for beginners”
2. Halbert, “Resisting Intellectual Property”, Taylor & Francis Ltd ,2007.
3. Mayall, “Industrial Design”, McGraw Hill, 1992.
4. Niebel, “Product Design”, McGraw Hill, 1974.
5. Asimov, “Introduction to Design”, Prentice Hall, 1962.
6. Robert P. Merges, Peter S. Menell, Mark A. Lemley, “Intellectual Property in New
7. Technological Age”, 2016.
8. T. Ramappa, “Intellectual Property Rights Under WTO”, S. Chand, 2008
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
LIST OF EXPERIMENTS:
1. Colorimetry / UV / Visible, Spectroscopy, scanning of few compounds for UV-absorption,
calculation of Assay / content uniformity / % of drug release (2-3 experiments.)
2. Simultaneous estimation of multi component containing formulations by UV
spectrophotometry
3. Experiment base on HPLC (Isocratic and gradient) Techniques – (2 experiments)
4. Incompatibility studies, identification and functional groups – Determination by FTIR
(2 experiments)
5. Separation and calculation of Rf values by using paper chromatography, TLC, HPTLC
Technique (2-3 experiments)
6. Calibration of glasswares
7. Calibration of pH meter
8. Calibration of UV-Visible spectrophotometer
9. Calibration of FTIR spectrophotometer
10. Calibration of HPLC instrument
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R19 M.PHARM PHARMACEUTICAL ANALYSIS
LIST OF EXPERIMENTS:
1. Determination of total reducing sugar
2. Determination of proteins
3. Determination of saponification value, Iodine value, Peroxide value, Acid value in food
products
4. Determination of fat content and rancidity in food products
5. Analysis of natural and synthetic colors & food additives in food
6. Determination of preservatives in food
7. Determination of pesticide residue in food products
8. Assay of any two Analgesic & Antipyretic drugs (API & dosage forms) official in IP
9. Assay of any two Antihistamines (API & dosage forms) official in IP
10. Assay of any two Diuretics (API & dosage forms) official in IP
11. Microbiological assay of any two Antibiotics official in IP
22
R19 M.PHARM PHARMACEUTICAL ANALYSIS
Prerequisite: None
UNIT-I:
Planning and Preparation, Word Order, Breaking up long sentences, Structuring Paragraphs and
Sentences, Being Concise and Removing Redundancy, Avoiding Ambiguity and Vagueness
UNIT-II:
Clarifying Who Did What, Highlighting Your Findings, Hedging and Criticizing, Paraphrasing and
Plagiarism, Sections of a Paper, Abstracts. Introduction
UNIT-III:
Review of the Literature, Methods, Results, Discussion, Conclusions, The Final Check.
UNIT-IV:
key skills are needed when writing a Title, key skills are needed when writing an Abstract, key skills
are needed when writing an Introduction, skills needed when writing a Review of the Literature,
UNIT-V:
skills are needed when writing the Methods, skills needed when writing the Results, skills are needed
when writing the Discussion, skills are needed when writing the Conclusions. useful phrases, how to
ensure paper is as good as it could possibly be the first- time submission
23
R19 M.PHARM PHARMACEUTICAL ANALYSIS
Prerequisite: None
UNIT-I:
Introduction:
Disaster: Definition, Factors and Significance; Difference Between Hazard and Disaster; Natural and
Manmade Disasters: Difference, Nature, Types and Magnitude.
Disaster Prone Areas in India:
Study of Seismic Zones; Areas Prone to Floods and Droughts, Landslides and Avalanches; Areas
Prone to Cyclonic and Coastal Hazards with Special Reference to Tsunami; Post-Disaster Diseases
and Epidemics
UNIT-II:
Repercussions of Disasters and Hazards:
Economic Damage, Loss of Human and Animal Life, Destruction of Ecosystem. Natural Disasters:
Earthquakes, Volcanisms, Cyclones, Tsunamis, Floods, Droughts and Famines, Landslides and
Avalanches, Man-made disaster: Nuclear Reactor Meltdown, Industrial Accidents, Oil Slicks and
Spills, Outbreaks of Disease and Epidemics, War and Conflicts.
UNIT-III:
Disaster Preparedness and Management:
Preparedness: Monitoring of Phenomena Triggering A Disaster or Hazard; Evaluation of Risk:
Application of Remote Sensing, Data from Meteorological and Other Agencies, Media Reports:
Governmental and Community Preparedness.
UNIT-IV:
Risk Assessment Disaster Risk:
Concept and Elements, Disaster Risk Reduction, Global and National Disaster Risk Situation.
Techniques of Risk Assessment, Global Co-Operation in Risk Assessment and Warning, People’s
Participation in Risk Assessment. Strategies for Survival.
UNIT-V:
Disaster Mitigation:
Meaning, Concept and Strategies of Disaster Mitigation, Emerging Trends In Mitigation. Structural
Mitigation and Non-Structural Mitigation, Programs of Disaster Mitigation in India.
24
R19 M.PHARM PHARMACEUTICAL ANALYSIS
1. R. Nishith, Singh AK, “Disaster Management in India: Perspectives, issues and strategies “’New
Royal book Company.
2. Sahni, Pardeep Et. Al. (Eds.),” Disaster Mitigation Experiences and Reflections”, Prentice Hall of
India, New Delhi.
3. Goel S. L., Disaster Administration and Management Text and Case Studies”, Deep &Deep
Publication Pvt. Ltd., New Delhi.
25
R19 M.PHARM PHARMACEUTICAL ANALYSIS
Prerequisite: None
Course Objectives:
To get a working knowledge in illustrious Sanskrit, the scientific language in the world
Learning of Sanskrit to improve brain functioning
Learning of Sanskrit to develop the logic in mathematics, science & other subjects enhancing
the memory power
The engineering scholars equipped with Sanskrit will be able to explore the huge knowledge
from ancient literature
UNIT-I:
Alphabets in Sanskrit,
UNIT-II:
Past/Present/Future Tense, Simple Sentences
UNIT-III:
Order, Introduction of roots,
UNIT-IV:
Technical information about Sanskrit Literature
UNIT-V:
Technical concepts of Engineering-Electrical, Mechanical, Architecture, Mathematics
26
R19 M.PHARM PHARMACEUTICAL ANALYSIS
Prerequisite: None
UNIT-I:
Values and self-development –Social values and individual attitudes. Work ethics, Indian vision of
humanism. Moral and non- moral valuation. Standards and principles. Value judgements
UNIT-II:
Importance of cultivation of values. Sense of duty. Devotion, Self-reliance. Confidence, Concentration.
Truthfulness, Cleanliness. Honesty, Humanity. Power of faith, National Unity. Patriotism. Love for
nature, Discipline
UNIT-III:
Personality and Behavior Development - Soul and Scientific attitude. Positive Thinking. Integrity and
discipline, Punctuality, Love and Kindness.
UNIT-IV:
Avoid fault Thinking. Free from anger, Dignity of labour. Universal brotherhood and religious
tolerance. True friendship. Happiness Vs suffering, love for truth. Aware of self-destructive habits.
Association and Cooperation. Doing best for saving nature
UNIT-V:
Character and Competence –Holy books vs Blind faith. Self-management and Good health. Science
of reincarnation, Equality, Nonviolence, Humility, Role of Women. All religions and same message.
Mind your Mind, Self-control. Honesty, Studying effectively
27
R19 M.PHARM PHARMACEUTICAL ANALYSIS
Prerequisite: None
UNIT-I:
History of Making of the Indian Constitution: History Drafting Committee, (Composition &
Working), Philosophy of the Indian Constitution: Preamble, Salient Features.
UNIT-II:
Contours of Constitutional Rights & Duties: Fundamental Rights Right to Equality, Right to
Freedom, Right against Exploitation, Right to Freedom of Religion, Cultural and Educational Rights,
Right to Constitutional Remedies, Directive Principles of State Policy, Fundamental Duties.
UNIT-III:
Organs of Governance: Parliament, Composition, Qualifications and Disqualifications, Powers and
Functions, Executive, President, Governor, Council of Ministers, Judiciary, Appointment and Transfer
of Judges, Qualification, Powers and Functions.
UNIT-IV:
Local Administration: District’s Administration head: Role and Importance, Municipalities:
Introduction, Mayor and role of Elected Representative, CEO of Municipal Corporation. Pachayati raj:
Introduction, PRI: Zila Pachayat. Elected officials and their roles, CEO Zila Pachayat: Position and
role. Block level: Organizational Hierarchy (Different departments), Village level: Role of Elected and
Appointed officials, Importance of grass root democracy.
UNIT-V:
Election Commission: Election Commission: Role and Functioning. Chief Election Commissioner
and Election Commissioners. State Election Commission: Role and Functioning. Institute and Bodies
for the welfare of SC/ST/OBC and women.
28
R19 M.PHARM PHARMACEUTICAL ANALYSIS
2. Dr. S. N. Busi, Dr. B. R. Ambedkar framing of Indian Constitution, 1st Edition, 2015.
3. M. P. Jain, Indian Constitution Law, 7th Edn., Lexis Nexis, 2014.
4. D.D. Basu, Introduction to the Constitution of India, Lexis Nexis, 2015.
29
R19 M.PHARM PHARMACEUTICAL ANALYSIS
Prerequisite: None
UNIT-I:
Introduction and Methodology: Aims and rationale, Policy background, Conceptual framework and
terminology Theories of learning, Curriculum, Teacher education. Conceptual framework, Research
questions. Overview of methodology and Searching.
UNIT-II:
Thematic overview: Pedagogical practices are being used by teachers in formal and informal
classrooms in developing countries. Curriculum, Teacher education.
UNIT-III:
Evidence on the effectiveness of pedagogical practices, Methodology for the indepth stage: quality
assessment of included studies. How can teacher education (curriculum and practicum) and the scho
curriculum and guidance materials best support effective pedagogy? Theory of change. Strength and
nature of the body of evidence for effective pedagogical practices. Pedagogic theory and pedagogical
approaches. Teachers’ attitudes and beliefs and Pedagogic strategies.
UNIT-IV:
Professional development: alignment with classroom practices and follow-up support, Peer support,
Support from the head teacher and the community. Curriculum and assessment, Barriers to learning:
limited resources and large class sizes
UNIT-V:
Research gaps and future directions: Research design, Contexts, Pedagogy, Teacher education,
Curriculum and assessment, Dissemination and research impact.
30
R19 M.PHARM PHARMACEUTICAL ANALYSIS
31
R19 M.PHARM PHARMACEUTICAL ANALYSIS
Prerequisite: None
Course Objectives:
To achieve overall health of body and mind
To overcome stress
UNIT-I:
Definitions of Eight parts of yog. (Ashtanga)
UNIT-II:
Yam and Niyam.
UNIT-III:
Do`s and Don’t’s in life.
i) Ahinsa, satya, astheya, bramhacharya and aparigraha
ii) Shaucha, santosh, tapa, swadhyay, ishwarpranidhan
UNIT-IV:
Asan and Pranayam
UNIT-V:
i) Various yog poses and their benefits for mind & body
ii) Regularization of breathing techniques and its effects-Types of pranayam
32
R19 M.PHARM PHARMACEUTICAL ANALYSIS
UNIT-I:
Neetisatakam-Holistic development of personality
Verses- 19,20,21,22 (wisdom)
Verses- 29,31,32 (pride & heroism)
Verses- 26,28,63,65 (virtue)
UNIT-II:
Neetisatakam-Holistic development of personality
Verses- 52,53,59 (dont’s)
Verses- 71,73,75,78 (do’s)
UNIT-III:
Approach to day to day work and duties.
Shrimad Bhagwad Geeta: Chapter 2-Verses 41, 47,48,
Chapter 3-Verses 13, 21, 27, 35, Chapter 6-Verses 5,13,17, 23, 35,
Chapter 18-Verses 45, 46, 48.
UNIT-IV:
Statements of basic knowledge.
Shrimad Bhagwad Geeta: Chapter2-Verses 56, 62, 68
Chapter 12 -Verses 13, 14, 15, 16,17, 18
Personality of Role model. Shrimad Bhagwad Geeta:
UNIT-V:
Chapter2-Verses 17, Chapter 3-Verses 36,37,42,
Chapter 4-Verses 18, 38,39
Chapter18 – Verses 37,38,63
33