Answer Posted / nisha

to become calibrate

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

856

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How to set analytical specification for combination products?

818

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What is the accrptance criteria in RSD for RS method precision on basis of impurity percentages?

825

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What is the formula to determine the concentration of M of a solution given the % transmittance? Use %T = 43.7 as an example.

2684

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How would you decide dissolution medium for NCE compound of class I drug

2256

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How to determine water content of bis tetrazole amine mono ammonium salt

3486

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if you have given one product then how you determine the impurity in that?

740

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In GC calibration,what is the procedure to calibrate the TCD (thermal counductivity detector)suggest ?

3178

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cefoperozone and sulbactam inj. hplc test method

2691

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What is the requirement for brazil in the analytical method vslidation comparr to ich?

782

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if peak get problamatic then what require to do?

805

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how require to fix the linearity and accuracy cincentration range?

1669

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

2666

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why require the ph, buffer during hplc mobile phase?

861

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what is difference in ods I ods II is this is realy from sorbent / packing characteristics or from other means

1972

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