what are the different methods of analysing related
substances test,what are LOD AND LOQ .HOW TO REPORT
IMPURITIES WHEN LOD AND LOQ LIMITS R SPECIFIED




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what are the different methods of analysing related substances test,what are LOD AND LOQ .HOW TO R..

Answer / ananthan chandrasekar

LOD-Limit of detection.It is the lowest amount of the
analyte that can be detected and not necessary to be
quatitated.

LOQ-Limit of Quantitation. It is the lowest amount of the
analyte that can be detected and quantified.

If u get the impurity value below LOD, impurity result can
be declared as BDL(Below detection limit)

If u get the impurity value morethan LOD value but lessthan
LOQ value,impurity result can be declared as BQL(Below
Quantitation limit)

Only those impurities which are exceeding LOQ value to be
declared as per calculated value and this value canbe
included for Total impurity calculation.
For reference, See the example
Impurity LOD LOQ Calculated value Result
A 0.002% 0.006 % 0.001% BDL
B 0.002% 0.006 % 0.003% BQL
C 0.002% 0.006 % 0.008% 0.008%
D 0.002% 0.006 % 0.009% 0.009%
Total impurity = 0.008% +0.009 % =0.017%

Is This Answer Correct ?    48 Yes 2 No

what are the different methods of analysing related substances test,what are LOD AND LOQ .HOW TO R..

Answer / hari prasad

LOD means Sample concentration whereever gets the lowest
detection and there sample has not quantified.

LOQ means Sample concentration whereever gives lowest
quantified detection and there sample has quantified.

The LOD&LOQ concentration where the precission %RSD would
have 'not more than 30% and 10%' respectively, those are
the finalised LOD and LOQ limits to report.

Now impurities can report based on established LOD&LOQ
limits i.e. Not detected or below LOQ.

Is This Answer Correct ?    14 Yes 3 No

what are the different methods of analysing related substances test,what are LOD AND LOQ .HOW TO R..

Answer / anupama_indukuri

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Is This Answer Correct ?    3 Yes 3 No



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