Fourth Professional, Second Semester, Pharmaceutics

PHARMACEUTICS-XVI (Pharmaceutical Quality Managements-II)
(Theory)


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1. BIOLOGICAL ASSAYS: Biological methods, Standard praprations and units of activity, Bioassay of antibiotics, Bioassay of insulin injection, Assay of prepared digitalis and Assay of Vitamin D.

2. ALCOHOL DETERMIANTION: Alcoholometric methods, Problem during distillation of alcohol, Method for liquids containing less than 30% or more than 30% alcohol and special treatment before distillation.

3. ALKALOIDAL DRUG ASSAY: Weighing for assay, Extraction of drugs, Maceration, Percolation, Continuous extraction, Puriifcation of Alkaloids and determination of alkaloids.

4. MISCELLANEOUS DETERMINATIONS AND TESTS: Determiantion of weight/ml, Water/Moisture content, Loss on Drying, Toxicity tests & Identification tests, Evaluation of Ointments, Ash contents and Alkalinity of Glass.

5. GENERAL KNOWLEDGE OF APPENDICES ATTACHED TO B.P., BPC, AND USP.

6. STATISTICAL INTERPRETATION OF QUALITY CONTROL CHARTS DURING MANUFACTURING PROCESSES.

PHARMACEUTICS-XVI (Pharmaceutical Quality Managements-II)
(Laboratory)

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NOTE:- Practicals of the subject shall be designed from time to time on the basis of the above mentioned theoretical topics and availability of the facilities, e.g. Sterility test, Determiantion of Ash contents, Determination of Moisture contents, Determination of total solids, Determination of viscosity of syrups, gels, etc., Determination of emulsion types.

Recommended Books

1. A H Beckett and J B Stennlake, Practical Pharmaceutical Chemistry, Part-I and II, The Alton Press, London.
2. A M Knevel and F E Digangi, Jenkin’s Quantitative Pharmaceutical chemistry, McGraw-Hill Book Company, New York.
3. K A Connors, A Text Book of Pharmaceutical Analysis, John — Wiley and Sons, New York.
4. A Braithwaite and F J Smith, Chromatographic Methods, Chapman and Hall, London.
5. G D Christian, Analytical Chemistry, John Wiley and Sons, New York.
6. Karamt A Javaid, Pharmaceutical Quality Assurance in Class, Industry and Market, Aziz Publishers, Lahore-Pakistan (1993).
7. Gil Bismuth and Shosh Neumann, Cleaning Validation, A practical approach. CRC Press, LLC, USA, 2003.
8. J T Carstersen and C T Rhodes, Drug Stability: Principles and Practices, 3rd Ed. (revised and expanded) Mercel Dekker, New York, 2000.
9. Sydney H Willig, Good Manufacturing Practices for Pharmaceuticals, Marcel Dekker Publishing.
10. Bryant R, The pharmaceutical Quality Control Hand Book, Aster Publishing Corporation, Eugene, 1989.
11. Braun R E, Introduction to Instrumental Analysis, McGraw-Hill Book Co, NY, 1987.