Answer Posted / sasusrinivas

Purity: is area %
Potency:is % of Analyte except water,sulphated ash and
Residue on ignition and also by mass balance
Assay:is % of Analyte by weight comparison with Standard

we can use expired sample for validation and analyst qualification?

819

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before starting analytical method valodation what you checking? and how giving preference to start validation?

813

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if peak get problamatic then what require to do?

806

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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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why xterra column require to use at higher ph?

921

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Why Ethanol is Used for Standardization of GC Head space?

4232

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what is procedure of actual procedure for registration of drug?

2012

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Which is the highly polar and highly non polar column in HPLC?

2310

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how to select short coloum and long coloumn for new molecule

2453

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How doing qbd practically?

980

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if identification threshold crosses the limits then what next step?

871

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Why only hydroxy naphthol blue indicator is used for standardisation of 0.05M EDTA solution instead of solochrome Black T or Euriochrome Black T indicator which is used for all sample analysis with 0.05M EDTA solution?

2734

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if your impurity coeluting with each other in that situation how require to set specification? is it acceptable?

989

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If suppose 10 methods of dissolution given in pharmacopoeial for single content product then which method out of 10? or all 10 require to follow?

998

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identification is for unknown? qualification for known? reporting for LOQ?

726

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