Macerate 5 g of the air-dried drug, coarsely powdered, with 100 ml of ethanol of the specified strength in a closed flask for 24 hours, shaking frequently during the first 6 hours and allowing to stand for 18 hours. Thereafter, filter rapidly taking precautions against loss of ethanol, evaporate 25 ml of the filtrate to dryness in a tared flat-bottomed shallow dish, dry at 105° and weigh. Calculate the percentage of ethanol-soluble extractive with reference to the air-dried drug.
Determination of Ethanol-Soluble Extractive
Learn how to determine the Ethanol-Soluble Extractive in Pharmaceutical Ingredients.
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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