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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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Answer Posted / 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 ? | 58 Yes | 3 No |
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