Answer Posted / nikhil gandhi

Based on ICH Guideline there are many method given to
identify LOD and LOQ, but most useful method is slope and
residual standard deviation is used.

LOD : 3.3 X sigma/ Slope
LOQ : 10 X sigma/ Slope

Sigma : Residual Standard Deviation

if tech transfer fails whay require to do?

855

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why require the ph, buffer during hplc mobile phase?

871

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Why sometime potassium ortho phosphate mix with acetone use for sample preparation for hplc

1475

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IS THERE ANY EQUIPMENT TO CHECK AND CALCULATE THE POLARITY OF A LIQUID?

2468

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Which parameter require to do for analytical method equivalency?

788

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why cone formation during dissolution?

795

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which situation gc hs and gc als require to use?

800

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[3/30, 13:29] Manoj P Venkatpurwar: How hplc column selection according to structure? How mobile phase buffer selection on molecule structure?

810

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What should be the level/ Percentage of Arsenic in Arsenic free zinc.

2233

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what are the guidelines for analytical method validations?

1110

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In BP2013, Loperamid HCl monograph. Assay by titration with 0.1N sodium hydroxide using hydrocloric acid 0.01N and reading the volume added between the 2 points of inflexion. I have a question that if the diluent solvent is ethanol is certainly consumed a amount of volume of titrant, so this volume must be eliminated on the result calculation or not apart from first point which is subtracted above.

3131

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what is different when impergnated silica plates are used in separation of azo dyes using column chromatography?

2033

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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?

4085

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

886

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Why only 1.2 million lux hours require in photostability study?

1046

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