Ethylene oxide and Dioxane Last updated 06NOV2013

USP Ethylene oxide and Dioxane Geneal !hapte 22"

Method I
Reagents:
#$etaldehyde %&ept in 'ee(e) on$e opened) only *ood 'o one yea+
Ethylene oxide %&ept in a headspa$e ,ial in 'ee(e) $onsult senio analyst i' -oe is needed+
1)./Dioxane %&ept in 'la--a0les $a0inet #/D+
1n house D1 2
2
O
Polyethylene Gly$ol 200 %&ept on P ea*ent shel') should ha,e ,ei'i$ation in'o on 0ottle+
Di-ethyla$eta-ide %D3#+ %&ept in 'la--a0les $a0inet #/D+
Solution Prep
#$etaldehyde Solution4 10 5*6-L solution
Ethylene oxide Sto$& Solution4 WE DO NOT USE TE PREP IN TE !ENER"#
$"PTER%%%% 7e -odi'y the pep to use the ethylene oxide ea*ent that is pe/pu$hased 'o-
Si*-a #ldi$h %to $ut do8n on analyst eo and EO is a health ha(ad+9 7e -a&e a :0 pp-
solution) then dilute do8n to 10 5*6-L solution9 %Please $onsult an old 8ite up to ensue the
pope pep o' solution9+ 3a&e a note in you note0oo& $on$enin* the di''een$e in peps o' the
Sto$& Solution9 Please sho8 to ;e$&y and ha,e he si*n o'' on it ON TE D"& O' PREP%
See an old 8ite up to *et 8odin* 'o the note9
Dioxane Solution4 :00 5*6-L solution
Standad Solution #4 091 -L o' Ethylene oxide Solution) 091 -L o' Dioxane Solution and 091
-L o' #$etaldehyde in a headspa$e ,ial9 Sealed9 %<his is you syste- suit solution9+
Standad Solution ;4 7ei*h 190* o' sa-ple into headspa$e ,ial) then add 091 -L o' Ethylene
oxide solution and 091 -L o' Dioxane Solution) and 190 -L o' D3#9 Sealed9
Sa-ple Solution4 7ei*h 190* o' sa-ple into a headspa$e ,ial) and added 190 -L o' D3# and
092 -L o' 8ate9 Sealed9