Answer Posted / ravendranadhareddy

Both are same
sulphated ash BP & IP Method 600°C
residue on ignition USP method 800°C

As per ICH related substances stability trend limit from initial to shelf life

3304

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If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately

907

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Ratio of Water and Acetonitrile(diluent) is not recommended to use in cleaning method validation,why?

3024

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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?

1040

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In which situation we require to analytical method validation of excipient?

843

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4. Describe the operation of the Craig apparatus. Chapter.3 Equilibrium Processes in Separations

2768

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how to decide for one product require water content or LOD?

840

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How require to perform linearity as per ANVISA? What are the acceptance criteria?

1400

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what is mean by dissolution biowaiver study?

995

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give clarity of linearity and range in method validation

2475

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what is difference between UV - VISIBLE MODEL NO like 1600,1601,1700 etc ? plz explain me

2734

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what is lod and loq ?,why use k2cr2o7 , kcl h2so4 in uv calibration ?,why use benzophenone & caffene acetone in hplc calibration ?,what is leading peak in hplc ?why we do the calibration of limit of stry light in hplc & uv ?

3724

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how you fix the limits of impurities?

893

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if you get peak in blank then what require to do?

1018

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

936

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