Ethylene Oxide Testing Requirements as per US-pharmacopoeia

v9991

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pharmacopoeia monograph suggests GC method with the ETO- standard to be prepared in the laboratory, by bubbling ETO-gas into a solution and standardizing the concentration on daily basis (before use)

now, if we replace the above procedure for analytical standard preparation with off the shelf stock solution from Sigma Aldrich (with COA.. [FONT=Calibri,Arial,Helvetica,sans-serif][FONT=Calibri,Arial,Helvetica,sans-serif]https://www.sigmaaldrich.com/catalog/product/fluka/phr1295?lang=en?ion=IN[/FONT][/FONT])
1. do we still need to standardize it on daily basis (before use)?
2. should be revalidate the analytical method?
 

v9991

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1. do we still need to standardize it on daily basis (before use)?
2. should be revalidate the analytical method?
we figured that, though the main stock solution is standardized by vendor, we still need to re-standardize it inhouse, before use because we are dilute it again before using in analysis, (knowing the nature of the ETO, there could be loss due to evaporation et.c,)
and about the revalidation of method, we figured out that precision is in order, + solution stability as well.

thank you
 
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