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EMULSIONS, OIL IN WATER (EW)

Introduction EW is the designation for a stable emulsion of active ingredient(s) in an aqueous phase, intended for dilution with water before use. he active ingredient is normall! a liquid and forms the dispersed oil phase, but it is also possible to emulsif! a solid or liquid active ingredient dissolved in a water immiscible solvent. Emulsions, li"e suspension concentrates, are metastable s!stems. herefore, after transportation and storage it ma! be necessar! to re#homogeni$e the formulation, either b! sha"ing small containers or b! stirring the contents of large containers. Emulsions ma! be non#%ewtonian liquids, with comple& rheolog!. 'lthough the rheolog! can influence the dilution characteristics, these are chec"ed indirectl! b! the emulsion stabilit! test. hese guideline specifications appl! to aqueous macro#emulsions onl! and not to other formulations such as suspo#emulsions ((E), inverse emulsions (E)) or micro#emulsions (*E).
%ote for preparation of draft specifications. +o not omit clauses or insert additional clauses, nor insert limits that are more la& than those than given in the guidelines, without referring to section ,. -rom the .%otes/ provided at the end of this guideline, incorporate onl! those which are applicable to the particular specification.

...... [ISO common name] EMULSION, OIL IN WATER 0123'1 number45EW (month 6 !ear of publication) 7.21.1 De cri!tion he formulation shall consist of an emulsion of technical ...... 02() common name4, compl!ing with the requirements of -')5W7) specification ...... , in the form of ....... (see (ection ,.2), in an aqueous phase together with suitable formulants. 'fter gentle agitation, the formulation shall be homogeneous (%ote 1) and suitable for dilution in water. 7.21.2 Acti"e in#redient 7.21.2.1 Identit$ te t (%ote 2) he active ingredient shall compl! with an identit! test and, where the identit! remains in doubt, shall compl! with at least one additional test. 7.21.2.2 ...... [ISO common name] content (%ote 2) he ...... 02() common name4 content shall be declared (g5"g or g5l at 28 291, %ote :) and, when determined, the average content measured shall not differ from that declared b! more than the appropriate tolerance, given in the table of tolerances, (ection ,.:.2.

7.21.: Re%e"ant im!uritie 7.21.:.1 &$'!roduct o( manu(acture or tora#e (%ote ,), if required *a&imum; ......< of the == 02() common name4 content found under 7.21.2.2. 7.21., )*$ ica% !ro!ertie 7.21.,.1 Acidit$ and5or A%+a%init$ (* 1>1) or !, ran#e (* 7?.:) (%ote ?), if required *a&imum acidit!; ...... g5"g calculated as 72(),. *a&imum al"alinit!; ...... g5"g calculated as %a)7. p7 range; ...... to ...... 7.21.,.2 )oura-i%it$ (* 1,@.1) *a&imum AresidueA; ...... <. 7.21.,.: Emu% ion ta-i%it$ and re'emu% i(ication (* :B.1.1, * :B.: or * 1@:) he formulation, when diluted at :8 C 2D1 (%otes B 6 7) with 123'1 (tandard Waters ' and +, shall compl! with the following;
ime after dilution 8h 8.? h 2.8 h 2, h 2,.? h %ote; in appl!ing * :B.1 or :B.:, tests after 2, h are required onl! where results at 2 h are in doubt 0G4 ime after dilution 2 min 7 to :2 min Eimits of stabilit!, * :B.1, :B.: 2nitial emulsification complete A1reamA, ma&imum; ...... ml A1reamA, ma&imum; ...... ml A-ree oilA, ma&imum; ...... ml Fe#emulsification complete A1reamA, ma&imum; ...... ml A-ree oilA, ma&imum; ...... ml

0G4 Eimits of stabilit!, * 1@: '1 reading ma&imum ...... '1 reading similar to above (no maHor increase, decline or fluctuation) %ote; in appl!ing * 1@:, initial '1 reading will be I1 in most cases

7.21.,., )er i tent (oam (* ,7.2) (%ote @) *a&imum; ...... ml after 1 min.

7.21.? Stora#e ta-i%it$ 7.21.?.1 Sta-i%it$ at ./0 (* :>.:) 'fter storage at 8 C 2D1 for 7 da!s, no separation of particulate or oil! matter shall be visible after gentle agitation. 7.21.?.2 Sta-i%it$ at e%e"ated tem!erature (* ,B.:) 'fter storage ?, C 2D1 for 1, da!s (%ote >), the determined average active ingredient content must not be lower than ......< relative to the determined average content found before storage (%ote 18) and the formulation shall continue to compl! with the clauses for; # b!#products of manufacture or storage (7.21.:.1), # acidit!5al"alinit!5p7 range (7.21.,.1), # emulsion stabilit! and re#emulsification (7.21.,.:), as required. JJJJJJJJJJJJJJJJJJJJJJJJ
%ote 1 'll ph!sical and chemical tests listed in this specification are to be performed with a laborator! sample ta"en after the recommended homogeni$ation procedure. Kefore sampling to verif! the formulation qualit!, the commercial container must be inspected carefull!. )n standing, emulsions ma! develop a concentration gradient which could even result in the appearance of a clear liquid on the top (sedimentation of the emulsion) or on the bottom (creaming up of the emulsion). herefore, before sampling, the formulation must be homogeni$ed according to the instructions given b! the manufacturer or, in the absence of such instructions, b! gentle sha"ing of the commercial container (for e&ample, b! inverting the closed container several times). Earge containers must be opened and stirred adequatel!. %ote 2 *ethod(s) of anal!sis must be 123'1, ')'1 or equivalent. 2f the methods have not !et been published then full details, with appropriate method validation data, must be submitted to -')5W7) b! the proposer. 2f the bu!er requires both g5"g and g5l at 28D1, then in case of dispute the anal!tical results shall be calculated as g5"g. his clause should include onl! relevant impurities and the title should be changed to reflect the name of the relevant impurit!. *ethod(s) of anal!sis must be peer validated. he method to be used shall be stated. 2f several methods are available, a referee method shall be selected. Lnless another temperature is specified. he formulation should be tested at the highest and lowest rates of use recommended b! the supplier. he mass of sample to be used in the test should correspond to the highest rate of use recommended b! the supplier.. he test is to be conducted in 123'1 standard water +. Lnless other temperatures and5or times are specified. Fefer to (ection ,.B.2 of this *anual for alternative storage conditions.

%ote : %ote , %ote ? 0G4 %ote B %ote 7 %ote @

%ote >

%ote 18 (amples of the formulation ta"en before and after the storage stabilit! test should be anal!$ed concurrentl! after the test in order to reduce the anal!tical error.