Pharmaceutical Technology - September 2021

Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2021 39 Aliquot versus portion. The term 'aliquot' is reserved for pre- pared and diluted solutions and the term 'portion' for samples taken from the analytical sample or reference standard. If the analytical sample was a liquid or suspension, the term 'portion' would still apply not 'aliquot'. The term 'test solution' is some- times used in place of the preferred term 'measurement aliquot'. The term 'measurement aliquot' is preferred because it is the specific solution upon which the metrology is carried out. Figure 3. Proposed nomenclature for Phase 1. =)*+($&,8&>("0"%$3&1"5$1:2/#+($&'"(&>./%$&?8! & & & & !"#$%"&$%'()"*+!, -$.)/0.*,.&1(!$&( 23(#"&-4(( "."!'&/-"!()"*+!, !"#$%#$&'($%)*" '+*,*&-$#.#$&'#/'"-01#"-% /.-%,*,.&)(23(5./&) 2*,3*.#4-%'#$5"-,-$4. -$*#/.,6()"*+!, 617.(,38-'#/'"-01#"-% 9(:'7-' 4+-'.(,-'(. 9(:'7-' 4+-'.(,-'(. )"*+!/.0 %,-$%6 The parent material (population) which is to be sampled The collection of one or more increments or units taken from a population as required by the material specific sampling procedure and the batch specific sampling protocol Increments may be combined (composited) to form a combined sample A sufficient and representative sample for testing that can be expected to adequately reflect the characteristics of the parent population Sample supplied for the application of a particular test procedure and is assumed to be homogeneous Term Definition ! ! 56"-,);<)) ="%12%".&0')530.010% 56"-,)><) !"#$%&'()5301,--)?@".,3&"%)!$,1&4&1A 56"-,)B<) 7'"%8.&1"%)C$,3".&0'- 56"-,)D<) !.".&-.&1"%)!"#$%&'()5%"') E,F2&3,#,'.-)"'*)G,4&'&.&0'- G&-$,'-,)03):,&(6)').,-.)$03.&0'-)&')"1103*"'1,):&.6).6,)"'"%8.&1"%)$301,*23, <=<>?@A4<>(-.B4CDE.C .C-B.@C(G<>EC ="%12%".,).6,)H,.:,,')"%&F20.)#,"-23,#,'.)3"'(,- ="%12%".,)') &'*&I&*2"%) 3,-2%.-) 430#).6,) "%&F20.)#,"'- G0).6,)3"'(,-)#,,.) .6,)"11,$."'1,)13&.,3&"J G0,-).6,)3"'(,)04) ')&'*&I&*2"%)3,-2%.-) #,,.).6,)"11,$."'1,)13&.,3&"J ?C! =B ="%12%".,).6,)E,$03."H%,)K"%2,)"-) .6,)#,"')04).6,)&'*&I&*2"%)3,-2%.- 5301,*23,) 9"&%23, =B 5301,*23, )9"&%23, ?C! <=<>?@A4<> .C4B.D !A=I .C4B.D A=DAGADE<>( .C!E>@! !A=I -.B@B4B> !A=I -.B4CDE.C +0(,.6,3):&.6 E"'(,-)L) M'*&I&*2"%-) >C 4B=!AI=HC=@J(>B@( 30(F<@49(( <=<>?@A4<>(!C A=4.CHC=@!(B.(E=A@! =0#$0-&.,*)&'13,#,'.- 4BHFA=CD(!C !2H-"#$%,)&4)3,F2&3,* @C!@(-B.@AB=8!: -B.@AB=(-.C-<.<@AB=8!: HCAKEB@8!: HC

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