Advance Analytical Technique Orientation Lectures K. G. Baheti Y. B. Chavan College of Pharmacy

Volumetric method of analysis An advanced study of the principles and procedures involved in the assay of following methods with special emphasize of the official drugs in IP: Non aqueous titration Complexometric titration Redox titration Diazotization Potentiometric and Conductometric titrations. Theory Procedure Factor Examples Analytical Chemistry by Gary Christian Indian Pharmacopoeia Non aqueous method: Acetazolamide, Albedazole, Allopurinol, Aspatame Redox: Ascorbic acid (iodimetry), Ascorbic acid tablet, cerimetry

Instrumental methods of analysis An advanced study of the principles and procedures involved in the instrumental methods and applications of Flame photometry, Fluorimetry, Nephelo-turbidimetry, Polarimetry Refractometry. Instrumental method of Chemical analysis – Chatwal G R.

X – Ray diffraction methods Theory, instrumentation and application of X – Ray diffraction methods, generation of x – rays, x-ray diffraction, Bragg’s law, x- ray powder diffraction, interpretation of diffraction patterns and applications. Instrumentation, X-Ray absorption, X-Ray florescence and X-Ray powder diffractometry and its applications to pharmaceutical formulation development To obtain information about the structure of crystalline materials The dominant effect that occurs when an incident beam of monochromatic X-rays interacts with a target material is scattering of those X-rays from atoms within the target material. In materials with regular structure (i.e. crystalline), the scattered X-rays undergo constructive and destructive interference. This is the process of diffraction. The diffraction of X-rays by crystals is described by Bragg’s Law, n(lambda) = 2d sin(theta). The directions of possible diffractions depend on the size and shape of the unit cell of the material. Instrumental method of Chemical analysis – Chatwal G R.

Impurity profiling: Forced degradation studies (Methodology), and Impurity profiling -Definition and sources of impurities: (Impurities associated in with APIs-Organic impurities (Process and Drug-related), Inorganic impurities, Residual solvents; Impurities related to formulation; Formation of impurities on aging). Guidance for Industry - Impurities in New Drug Substances Q3A; Guidance for Industry Impurities in New Drug Products.Q3B (R2). Impurity profiling is the process of acquiring and evaluating data that establishes biological safety of an individual impurity; thus, revealing its need and scope in pharmaceutical research. Classification: Impurity profiling by Satinder Singh Ahuja Handbook of modern method of analysis Satinder Singh Ahuja www.ich.org

WHO guide lines of the standardization of Herbal raw materials and finished products. Morphological, microscopical, cytomorphological and chemical examinations of raw materials and finished products.

Standardization of food and cosmetic products Different types of additives used. Physicochemical characterization in whole form, separation and identification of active principles, excipients and their estimation by different techniques. Analysis of fermentation products like wine, spirits, beer and Vinegar. Introduction to Chemical analysis of food By S.S. Nielsen

Government Regulations To maintain the quality To ensure the food industry provides consumers with wholesome and safe foods To inform consumers about the nutritional composition of foods To enable fair competition amongst food companies To eliminate economic fraud

Test of packaging materials Cartons, Aluminum foils, Strip packing, Blister packing, Ampoules, vials

General methods of analysis for oils and fats Iodine value, Saponification value, Acid value, Rancidity special tests for Arachis oil, sesame oil, Sunflower oil, cotton seed oil, fish oil fat soluble vitamins (Vit A and Vit-D ) Indian Pharmacopoeia- (2007) 78-82, 2020 Some special test are given in I. P. and some need to find out.

A detailed study of the principles, instrumentation and applications of Raman Spectroscopy Instrumental method of Chemical analysis – Chatwal G R.