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%

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.

Answer / anupama_indukuri

---

What is polymorphism?which type of compounds exhibits polymorphism?

2 Answers   Torrent Pharma,

---

How to calculate mass balance in RS after degradation

1 Answers   Reddy Labs,

---

What is the meaning of 624 in DB-624 Capillary column used in GC?

5 Answers   Aurobindo,

---

why using Potentometry What Purpose? differance between manual and potentiometry? why using Some of materials in usig potentiometry? What is use of mericuric acetate in Potentiometry

1 Answers   Biocon,

---

In the method validation proceedure,lod & loq calculation we use the formulae for LOD=3.3*SD/slope and for LOQ=10*SD/slope,why we use 3.3 & 10 in the formulae?

1 Answers  

---

what is method development parameter in HPLC method development

6 Answers   GVK,

---

For LOD and LOQ determination which method is accurate? (slopemethod or s/n ratio method)

4 Answers   Reddy Labs,

---

WHAT IS THE USE OF STARTER ?????????

0 Answers   Sharp,

---

is there any material other than caffene to calibrate hplc detector

13 Answers   Biocon,

---

why chiral compounds will rotate the plane polarized light in SoR.

4 Answers   GVK,

---

in stress study if your api not soluble in hcl naoh h2o2 then what require to do?

0 Answers  

---

for inorganic molecules require to do RS, Assay and disso?

0 Answers  

---