how you fix the limits of impurities?
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Answer / Nitin Kumar Malviya
The limits of impurities, also known as impurity specifications, are set based on various factors such as safety, efficacy, and regulatory requirements. The International Council for Harmonisation (ICH) provides guidelines for establishing acceptable limits of impurities in pharmaceuticals. Factors affecting the limit setting include the nature and amount of impurities, their potential toxicity, and the intended use of the drug substance.
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2. Two grams of Benzoic acid are dissolved in 200 ml of water and extracted with 200 ml of diethyl ether. The distribution coefficient of benzoic acid is 100, and its dissociation constant is 6.5 10-5. Calculate the distribution ratio (D) of benzoic acid at pH 2, 5, and 6. 3. Calculate D at pH 2 to 10 (1 unit apart) in the above problem, and plot D versus pH.
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