FACULTY OF PHARMACY. M. Pharmacy I Semester (Suppl.) Examination, November 2015 (Common To All) Subject: Pharmaceutical Analytical Techniques

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1 M. Pharmacy I Semester (Suppl.) Examination, November 2015 (Common To All) Subject: Pharmaceutical Analytical Techniques Code No / S Note: Answer any Five questions. All questions carry equal marks. 1 a) Describe the instrumentation and applications of UV-visible spectrophotometer. 7 b) Discuss Woodward-Fieser rules for calculating the max for conjugated dienes by taking suitable example. 7 2 a) Discuss the principle, instrumentation along with a sketch diagram and applications of Fourier Transform Infra Red) (FTIR) spectrometer. 7 b) Draw schematic IR spectra for the following compounds and write the interpretation i) C 2 H 5 COCH 3 ii) C 6 H 5 -CH 2 COOH iii) C 6 H 5 -CHO 7 3 a) Write the theory and principle of proton NMR spectroscopy. Write about shielding and deshielding effects in NMR spectrum. 7 b) Discuss the effect of spin-spin coupling and explain how it is useful in structure elucidation of a compound with the help of a schematic NMR spectrum of a suitable compound. 7 4 a) Write a detailed account on various ionization techniques in Mass Spectrometry. 7 b) Discuss the fragmentation patterns and fragment characteristics in relation to parent structure and functional groups by taking suitable examples from straight chain and cyclic compounds containing hetero atoms. 7 5 a) Discuss various stationary phases and their applications in HPLC. 7 b) Write the instrumentation and applications of HPTLC. 7 OU OU Write notes on: 2x7 a) Derivatisation methods in GC b) Gel permeation chromatography 7 a) Write about preparative electrophoresis. 7 b) Write the principle and applications of capillary electrophoresis. 7 8 Write notes on: 2x7 a) Radioimmuno assay b) Chiral chromatography.

2 Code No / S M. Pharmacy (Pharmaceutics / Ind.Pharm.) I Semester (Supplementary) Examination, November 2015 Subject: Industrial Pharmacy I (Pharmaceutical Production Tech.) Note: Answer any Five questions. All questions carry equal marks. 1 a) Describe in detail about the fluidized bed coating process with the problems during handling. 7 b) Discuss the working of rapid mixer granulator. 7 2 a) Explain the principle and working of lyophilizer. 7 b) Explain the principle and working of laminar air flow unit. 7 3 Write a note on the following: a) Spheronization 7 b) Reverse Osmosis 7 4 a) Describe the preparation of demineralised water and water for injection. 7 b) Explain powder filing techniques of hard gelatin capsules. 7 5 a) With the help of layout, explain the process of manufacturing of parenterals. 7 b) Discuss the principle and working of AHU s. Add a note on humidity and temperature control. 7 6 Write a note on: a) Blister packing 7 b) Tamper proof packaging 7 7 a) Discuss in detail the manufacturing process of soft gelatin capsules. 7 b) What are the applications, advantages and disadvantages of different packaging material. 7 OU OU a) Write the GMP requirements for labelling of pharmaceuticals. 7 b) Discuss package printing for different dosage forms. 7

3 Code No / S M. Pharmacy (Pharmaceutics / PA & QA / IP) I Semester (Suppl.) Examination, November 2015 Subject: Pharmaceutical Product Development Note: Answer any five Questions. All questions carry equal marks. 1 (a) Explain the mechanism involved in improving the solubility of solids by complexation, solid dispersion and surfactants. (10) (b) Explain the influence of ph on solubility of weakly acidic and basic drugs. (4) 2 (a) Explain the mechanism of dissolution. What are the factors influencing dissolution of weakly acidic drugs? (10) (b) What are sink and non-sink conditions? How these conditions are are simulated in dissolution testing? (4) 3 (a) Explain the following terms: (8) i) Angle of repose ii) Flow rate iii) Carr s index iv) Hausner ratio (b) How to detect thepolymorphic changes of crystalline drugs? What is the importance of polymorphism in formulation? (6) 4 Explain the principle and methodology used in assigning shelf life or expiry data for the drug formulations. (14) 5 How to stabilize the drugs against oxidation, reduction, hydrolysis and photolysis(14) 6 What are the preformulation study considerations for developing tablet dosage form? (14) 7 What are the factors influencing incorporation of additives in formulation development. Explain with examples. (14) OU OU Explain in detail the preformulation studies of a drug formulated into injection. (14)

4 Code No / S M. Pharmacy (Pharmaceutics) I-Semester (Suppl.) Examination, November 2015 Subject: Quality Assurance Note: Answer any Five questions. All questions carry equal marks. 1 Write a note on the following terms in quality assurance a) Change control 7 b) Humidity control charts and tests 7 2 a) Explain in detail the problems encountered during manufacture of suspensions and trouble-shooting. 7 b) What are the IPQC tests performed during manufacture of suspensions? 7 3 Write a note on: a) Microbiological monitoring in production facilities 7 b) Equipment (cleaning, maintenance, celebration and handling) 4 a) Write a note on the principle, instrumentation and applications of thermogravimetric analysis (TGA). 8 b) Write a note on X-ray crystallography. 6 5 a) What is the significance of Differential Thermal Analysis (DTA) in quality assurance? Write a note on data interpretation. 8 b) Write a note on rotating crystal technique. 6 6 a) Give a flow chart on the organization of QC lab. 8 b) Maintenance of test and retention samples. 6 7 Write a note on the following: a) Safety guidelines to be followed in QC lab 8 b) Sampling procedures 6 8 Give the detailed procedure for analysis of data using X charts and R charts. 14 OU OU

5 Code No / M M. Pharmacy (Common to All) I-Semester (Main) Examination, April 2015 Subject: Pharmaceutical Analytical Techniques Note: Answer any Five questions. All questions carry equal marks. 1 (a) Write a detailed account of various types of electronic transitions induced by the interaction of UV radiation with organic molecules. 7 (b) Explain the effect of solvent and ph on the UV absorption maxima of organic molecules. 7 2 (a) Write about the fundamental principles of NMR. Explain the instrument used in NMR by means of a neat sketch. 8 (b) Discuss applications of 1 H-NMR in structure elucidation. 6 3 (a) Explain the basic principles involved in mass spectrometry. Discuss the construction of a mass spectrometer in detail. 8 (b) Give a detailed account of fragmentation patterns for carboxylic acids and alcohols. 6 4 (a) Write in brief about the basic principles involved in HPLC. Enlist various stationary phases used in HPLC. 6 (b) In HPLC, explain how do you increase the resolution of compounds in a given mixture. 8 5 Write about: (a) Finger print region in IR spectroscopy. 7 (b) Mc Lafferty rearrangement in mass spectrometry. 7 6 Write an account of: (a) Principle and Applications of Radioimmuno Assay Methods 7 (b) Principles, Instrumentation and Applications of Zone electrophoresis. 7 7 (a) What is necessary criterion for absorption to occur in the IR region? What types of molecular vibrations are associated with IR absorption? 7 (b) Compare and contrast between conventional IR and FTIR spectrophotometer with respect to working principle, sensitivity and instrumentation. 7 OU OU (a) Discuss about various derivatisation methods in gas chromatographic analysis. 6 (b) Explain in detail the principle and working of any three detectors in GC. 8

6 Code No / M M. Pharmacy (Pharmaceutics/I.P.) I Semester (Main) Examination, April 2015 Subject : Industrial Pharmacy I (Pharmaceutical Production Tech.) Time : 3 hours Max. Marks : 70 Note : Answer any FIVE questions. All questions carry equal marks. 1 a) Explain the process of fluidized bed coating. 7 b) Add a note on remedies for the problems encountered during fluidized bed coating. 7 2 Discuss about the different types of granulators used in the production of tablets. Suggest the remedies for problems encountered during production 14 3 a) Explain the various principles in powder filling of hard gelatin capsules. 7 b) Write a note on tamper proof packaging. 7 4 Give plant layout and facilities for the production of parenterals a) Discuss about the different types of packaging materials with their applications. 7 b) Explain the principle and working of lyophilizer. 7 6 a) Discuss about the production of dispersion system. 7 b) Write a note on homogenizers. 7 7 a) Write the principle and working of laminar air flow unit. 7 b) Discuss the preparation of DM & WFI water. 7 8 Write a note on the following : 7+7 a) Blister packing b) Humidity and temperature control ** OU OU

7 Code No / M M. Pharmacy (Pharmaceutics/PA & QA/Ind. Pharm.) I Semester (Main) Examination, April 2015 Subject: Pharmaceutical Product Development Note: Answer any five Questions. All questions carry equal marks. 1 (a) Define solubility, explain the factors influencing solubility of solids in liquids. (7) (b) Explain the methods to improve the solubility of poorly water soluble drugs. (7) 2 (a) Classify dissolution models. Explain type I & II dissolution test apparatus. (9) (b) What is the need for in vitro in vivo correlations? Mention the reasons for poor IVIVCs. (5) 3 (a) Explain the micromeretic properties influencing the flow of powders. (9) (b) How flow properties are quantified. (5) 4 How do the temperature, humidity and light influence the rate of reaction. How are these utilized in conducting accelerated stability studies? (14) 5 (a) What is factorial design? How is factorial design utilized for the process development of pharmaceutical formulations? (10) (b) What are the various tools to carry out compatibility studies in preformulation? (4) 6 Discuss the preformulation studies of drug for tablet dosage form. (14) 7 Discuss accelerated stability studies and determination of shelf life. (14) 8 Discuss various factors properties to be considered while selecting the formulation additives.. (14) OU OU

8 Code No / M M. Pharmacy (Pharmaceutics) I Semester (Main) Examination, April 2015 Subject : Quality Assurance Time : 3 hours Max. Marks : 70 Note : Answer any FIVE questions. All questions carry equal marks. 1 a) Differentiate quality control and quality assurance. 5 b) Write in detail about tests for air flow pattern, temperature and pressure control. 9 2 a) Discuss the quality tests for raw materials and packaging materials. 7 b) Write about various requirements for buildings and facilities in pharmaceutical industry. 7 3 a) Define IPQC. Write detailed procedures of IPQC for parenterals. 7 b) Discuss the problems encountered in the manufacturing of tablets along with trouble shooting. 7 4 Discuss X-ray diffraction techniques to determine the physical structure of drug particle or excipient particle Write about principle, instrumentation along with applications for the following : a) DSC 7 b) TGA 7 6 a) Define validation write about various validation parameters. 8 b) Mention desirable qualities of analyst. 6 7 Write a short note on : a) ANOVA 5 b) Applications of control charts 5 c) Probability 4 OU OU Discuss about the in process quality control tests for parenterals and explain the importance of QA system to obtain a desired quality parenteral product. 14 **

FACULTY OF PHARMACY. M. Pharmacy I Semester (Suppl.) Examination, November 2015 (Common To All) Subject: Pharmaceutical Analytical Techniques

FACULTY OF PHARMACY. M. Pharmacy I Semester (Suppl.) Examination, November 2015 (Common To All) Subject: Pharmaceutical Analytical Techniques M. Pharmacy I Semester (Suppl.) Examination, November 2015 (Common To All) Subject: Pharmaceutical Analytical Techniques Code No. 6001 / S 1 a) Describe the instrumentation and applications of UV-visible