Answer Posted / j.asghari

Hi,what's differ related and impurity in drug substances

what is mean by dissolution biowaiver study?

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some product having water content method with pyridine and ethylene glycol mixture instead of methanol? how they are selecting and methanol is not suitable solvent how ?

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Why we check moisture,ash & AIA in product

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if content uniformity passing but dissolution varrying then what is next step?

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What is intact assay method development.....?

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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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For limit test of heavy metals in BP, Method C require that the substance is ignited at a temperature not exceeding 800 °C. Why confines such the temperature?

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please explian me about area normalisation method,diluted standard method,impurity vs impurity and which one has to be selected in method development

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what parameters we will consider while developing a HPLC method and how we confirm our HPLC method is valid?

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if your product is soluble in 0.1n hcl and water then which you choose as media from these 2 media?

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if tech transfer fails whay require to do?

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how require to set assay concentration for standard and sample?

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What is viod volume and peak purity in HPLC?

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can we use the same detector in HPLC as well GC and what could be the differences we can find in the final chromato graph in any aspects?

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UV and PDA detector, which have less signal to noise ratio?

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