Why we are injecting low load standard conc. while analysing Related Substances by HPLC?

Answer Posted / rajkumar

It is the concentration of the Unknown impurity which comes
from the reporting threshold. For any query see ICH Q3B(R2)

Is This Answer Correct ?    6 Yes 0 No



Post New Answer       View All Answers


Please Help Members By Posting Answers For Below Questions

how you start RS method development when for new product?

284


If combination product how require to identify which imp is of which api?

315


How do we fix the sample concentaryion in hplc method development?

664


What is similarity factor and its use in api strength?

785


in dissolution if one bowl got 70 percent 2nd bowl got 80 percent and 3rd bowl got 90 percent then how proceed?

328






Which parameters require to do in tech transfer?

268


USP methodology, EP methodology, IP methodology, among three if possible to use one methodology for qualify working standard to use USP, EP, IP ? Please explain...

1551


What is similarity factor?

721


In the HPLC Calibration done wavelength accuracy done between 200nm-280nm .but not done remaining 300-400nm not done ?

455


i want model written test paper for the post of analyst in IOCL(indian oil corporation ltd) any one pls help me

2182


why octanol used to determine the partition coefficient ?

1914


What is split ratio in Gc? Splitless? how requirr to select?

319


we can use expired sample for validation and analyst qualification?

293


what is mean by dissolution biowaiver study?

322


How do we fix the sample concentaryion in hplc method development. What is the basis?

673