Analytical validtion-residual solvents by GC

GOOD VALIDATION PRACTICE (cGVP)
1

Regarding Residual solvents by GC, we are using Dimethylsulfoxide (DMSO) as blank solution in our analysis and validation also done. Now we are going to change 1-methyl-2-pyrrolidone(NMP) as blank solution instead of DMSO due to peak separation for required solvents and rest method is same. In this view, pleas help me

  • should be considered as a new method
    -which validation parameters are required for validation
  • how can we show the equivalence
  • guideline reference, if any
  • any other suggestions

YSVHALU
09357849498

2

Can you give an indication of the tests performed during the validation of DMSO as blank solution?

Reason I ask this is that when you change the blank solution there are certian tests that requires to be repeated.