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
Answers were Sorted based on User's Feedback
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 ? | 57 Yes | 3 No |
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 ? | 15 Yes | 3 No |
Can we interpret accuracy from linearity in method validation?
In Analytical method development related substance method when did follow w/w method when did follow area normalisation method
2 Answers Dr Reddys, Sun Pharma,
what buffer you can select for acidic nature analyte and how ?
Home heating oil or furnace oil what is made from? Can (base oil plus diesel/kerosen) = home heating oil?
what is difference between IR lamp and polarimeter lamp
Why using Holmium oxide in UV calibration
8 Answers Dr Reddys, Matrix, Nakoda Chemicals, Orchid,
What is delay volume?
how decide the clining method and cleaning method validation require for this perticular products?
effect of Ph during analytical run ?
1 Answers Lambda Therapeutic Research,
What is vial equlibriation in Gc?
From peak purity spectrum, where or at which point peak purity angle & purity threshold is checked?
IN pH CALIBRATION,CALIBRATION IS DONE FOR pH METER OR ELECTRODE?HOW WILL YOU JUDGE THAT THE METER TO BE CALIBRATED WITH 4,7,9.2 BUFFERS?EXPLAIN TEMPERATURE EFFECTS ON pH.