Boil a convenient quantity of ethanol (95 percent) thoroughly to expel carbon dioxide and neutralize it to phenolphthalein solution. Unless otherwise stated in the individual monograph, weigh accurately about 2 g or other suitable quantity of the substance under examination so that the volume of 0.5 M ethanolic potassium hydroxide added is at least twice that theoretically required, dissolve it in 5 ml of the neutralised ethanol contained in a hard-glass flask and neutralise the free acid in the solution with 0.1 M ethanolic potassium hydroxide using 0.2 ml of phenolphthalein solution as indicator. Add 25.0 ml of 0.5 M ethanolic potassium hydroxide and boil under a reflux condenser on a water-bath for 1 hour. Add 20 ml of water and titrate the excess of alkali with 0.5 M hydrochloric acid using a further 0.2 ml of phenolphthalein solution as indicator. Repeat the operation without the substance under examination. The difference between the titrations represents the alkali required to saponify the esters.
Jul 13, 2011
Determination of Esters
Learn how to determine the Esters in Pharmaceutical preparations.
Dr. Ankur Choudhary is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question
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