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GC method validation
Posted: Fri Jan 20, 2006 7:18 am
by 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??
validation
Posted: Fri Jan 20, 2006 12:57 pm
by 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
GC method validation
Posted: Thu Feb 02, 2006 10:22 am
by mahs
hi
Go through the ICH guidelines for validation.