Dear All
For swab sample analysis, if we adopt scan method on UV spectrophotometer in range of 200 - 400nm, then it should be validated or not.
for standard having 10 ppm coincentration solution is used of respective molecule.
we are already using a calibrated instruemnt.
is it necessary to validate the scan method on UV spectrophotometer?
awaiting your valuable reply.
Yes it is absolutely required to validate the UV method validation.
As per ICH Q2R you have to perform Accuracy, precision, LOD, LOQ, Linearity, ruggedness, etc.
Satish Dange
9177001923
Dear Nimesh,
what eveer the analytical method used for cleaning validation / verification should be validated as per ICH guidelines, the method should be validated for Accuracy, Precision, sensitivity, linearilty, rugedness, roboustness, and Recovery.
regards,
Sri