GC method validation

[kramus]

I want to validate HS - GC method for ethanol in product. Is there any official or unofficial source of rules with acceptance criteria of validation parameters for this kind of method??

[chromatographer1]

See the requirements of the USP or EU.

but for a start: 1,2,3

reproducibility
linearity
Limit of detection

both from dissolution solvent and from matrices dissolved in dissolution solvent.

Selectivity of analysis, able to separate other possible contaminants or decomposition products of the matrix. Non-specificity of vendor of columns used.

best wishes,

Rod

[mahs]

hi

Go through the ICH guidelines for validation.