Answer Posted / d.sambireddy

oos-out of specifications and oot-out of trend
this two words regular using all pharma industry

1) When ever we are using OOT controling of our quality
and controling of our process

2)Where ever we are using OOS(suppose in investigation
product is not meets the specification)

we will improve next future quality and avioding mistakes
from analysis and processing

in DMF having extra impurities and in api COA also having extra imp than USP or BP product then how require to proceed?

890

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EXPLAIN THE CALCULATION PART OF AN KF TITRATOR CALIBRATION WITH SUITABLE EXAMPLE

2694

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Qc interview questions

1798

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Loss of linearity in tkn analysis, possible reasons?

1369

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if identification threshold crosses the limits then what next step?

920

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can i use hplc detector to uplc and why?

2354

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why octanol used to determine the partition coefficient ?

2499

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What is mean by PDR?

1032

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

2280

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Many times I don't got a caffeine peak in calibration of hplc using guard column ❓

1879

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in hplc chromatogram started from left to right and in uv spectrum started from left to right

1019

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If vendor having more imp than monograph then how to proceed? and how to set spec?

1009

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what is mean by peak intigrity?

1029

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what is classification of elemental impurities? what is risk assement in elemental impurities?

811

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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?

1046

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