Acceptable range for variation in Retenttion time

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

Dear All,

What are the Acceptable range for variation in Retenttion time of Main peak

Thanks,

Vikas

2

[FONT=“Comic Sans MS”]Acceptance criteria for retention time variation is 0.2 minutes[/font]

3

may i know where you got the specification from? USP? BP?

4

Even I would like to know on what basis 0.2 minutes is decided? and if it varies and the chromatography is acceptable :(then what?

5

Hi
Acceptance criteria of RT of main peak under system suitability is 2.0 % (replicate injection)
Acceptance criteria of identification test by RT is 5.0 %