Explain in detail what are the procedure and calculations
involved for accuracy (%Recovery)in method validation?
Answer Posted / srinivas
Amount recovered (µg)
% Recovery = -------------------------X 100
Actual amount added (µg)
AreaSampleX Wt.Std X Potency
Amount recovered(µg)= ----------------------------
Area of Standard x 100
Amount added (µg) X Potency
Actual amount added(µg)= ----------------------------
100
Weight of std taken for recovery stock(mg)
( X Recovery Stock Solution addaed (ml)X1000
Amount added(µg)= ---------------------------------------
10
| Is This Answer Correct ? | 1 Yes | 4 No |
Post New Answer View All Answers
Why only Copper standard is used to calibrate Atomic Absorption spectrophotometer?
Why sometime potassium ortho phosphate mix with acetone use for sample preparation for hplc
what is lod and loq ?,why use k2cr2o7 , kcl h2so4 in uv calibration ?,why use benzophenone & caffene acetone in hplc calibration ?,what is leading peak in hplc ?why we do the calibration of limit of stry light in hplc & uv ?
what is definition of validation? which components are followed give detail?
If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately
Please give idea about method development for cleaning method and how maco level establish
in which situation require to change rs specification?
analytical method validation require to with respect to release specification or shelf life specification?
give clarity of linearity and range in method validation
[3/30, 13:29] Manoj P Venkatpurwar: How hplc column selection according to structure? How mobile phase buffer selection on molecule structure?
if your impurity coeluting with each other in that situation how require to set specification? is it acceptable?
How to know the estimated LOQ concentration in ppm
CAN WE DETERMINE THE PEAK PURITY IN GAS CHROMATOGRAPHY ANALYSIS?
in DMF having extra impurities and in api COA also having extra imp than USP or BP product then how require to proceed?
What is similarity factor?