chp02 Drug purity and its control课件.ppt

Chapter 2 Drug purity and  its control;Section 1 The purity of drug ;Section 2 Impurities and  their sources ; 2. The sources of impurities 2.1 The manufacturing process (1) the starting material and its impurities (2) intermediates side-products isomer Polymorphs decomposed products in purification (3) reagents, solvent, and catalysts used in the process (4) reaction vessels;Example: ① ? ② NaCl for pharmaceutical degree impurities: Ca、Mg、Ba salts or heavy metals;2.2 The storage period (chemical and physical instability) (1)?temperature, moisture, sun light (ultraviolet), air (oxygen) etc. or microbial effects (2) hydrolysis, oxidation, decomposition, isomerization, polymorphic, polymerization etc. ;Example: ① degradation of Aspirin ? ② tetracycline antibiotics ? ;Section 3 Test of impurity and its limit  estimation ;2. Estimation of limit amount of impurity Limit (%)= × 100 amount of sample ?  volume × conc. of impurity standard solution Limit (%)= × 100 amount of sample (drug) ;Example 1. The test for Chlorides in Paracetamol To 2.0g of paracetamol add 100ml of water,  and heat to make it dissolve, (allow to) cool, filter, pipet 25 ml of filtrate to test, using 5.0 ml of standard Sodium Chloride  solution (10