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Alternative Column for Glass Column Packed
Posted: Mon Feb 19, 2024 7:16 am
by mrezkighassani
I have a column with the following specifications
Zebron ZB-50, GC cap, column 30 m x 0.32 mm x 0.50 um (G17)
I want to analyze using GC based on the compendial method, in the reference the column used is 1 m x 4 mm, glass column packed with 5% liquid phase G17 on 100 - 120 mesh support S1AB. Are the two columns equivalent? If not, is there a column recommendation that is equivalent to the column used in the reference?
Thank you for your time.
Re: Alternative Column for Glass Column Packed
Posted: Mon Feb 19, 2024 2:35 pm
by Consumer Products Guy
I would've thought glass columns were obsolete, I hadn't used those since about 1980 when fused-silica capillaries became available.
Of course, compendial methods seem to rarely change...
Re: Alternative Column for Glass Column Packed
Posted: Tue Feb 20, 2024 1:03 am
by mrezkighassani
I also think that it is very rare to use the glass packed column method. But in terms of the regulations in our place, we have to be able to explain the reason for not using the column. I need references that can be used as justification for using the capillary column as an alternative.
Re: Alternative Column for Glass Column Packed
Posted: Thu Feb 29, 2024 9:32 pm
by MichaelVW
Who enforces the regulations? They must have a lab that runs the test. Can you just call those people and ask?
Re: Alternative Column for Glass Column Packed
Posted: Fri Mar 01, 2024 1:46 pm
by Consumer Products Guy
They must have a lab that runs the test.
Ha !!! I wouldn't bet on that.
Would the two columns perform the same, as both are G17? No, the capillary would likely be better.
The original poster did not exactly state that he was assaying something that needed to be for a regulated product (e.g. cGMP); but if so, the QA department needs to get some documentation on file stating their rationale for such change. USP <621> even lists some changes which do not need validation (unless one has a pointy-haired boss like I had, who didn't believe what the 26 letters formed on the page).
Re: Alternative Column for Glass Column Packed
Posted: Mon Mar 25, 2024 3:19 am
by mrezkighassani
The product will be marketed to SEA region and USP regulation is used. I asked the USP and they advised me to do a full validation. Thanks for the help.