Need Help - Method Validation for Qualitative GCMS analysis

[Tarapan]

Hi all,

I am planning for a method validation project but in terms of Qualitative analysis for GCMS.

This project basically involves using the GCMS to identify Pharmaceuticals. (The ones that are volatile enough to be tested in GC).

I will use Library search to identify my unknowns. then I would compare their retention time to the Reference standards that is available in our lab.

After going through some guidelines for Method validation, the ones I found so far mostly emphasize method validation for Quantitative analysis.

So I was wondering if anyone knows any other useful guidelines I could use that emphasize more on qualitative analysis especially for GCMS.

In terms of reference standards for qualitative, does the reference standards need to be a certified ones? or are analytical grades (with CoA) sufficient for this purpose?.

Tarapan

[grzesiek]

ICH states that specificity has to be shown for Identification test, clearly robustness and SST should also be included

There are some papers you can look at, just search for Esther Trullols

[Tarapan]

Thanks grzesiek

After a whole day of reading through Esther Trullols paper, I find the paper to be quite a helpfull guide. but adapting his guidlines it for Qualitative GCMS might be a bit tricky as his case studies mostly focuses on Kits like ELISA rather than chromatography

Tarapan