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(>A>10<8), B0/01> 7 :5@V2=8:>< 70<>2=8:0 (?V4?C=:B 7 ?C=:BC 47 A>1;82>AB59)#G0A=8: ?@>F54C@8 70:C?V2;V ?V4B25@46CT 2V4ACB=VABL ?V4AB028 H;OE>< A0<>ABV9=>3> 45:;0@C20==O 2V4ACB=>ABV B0:>W ?V4AB028 2 5;5:B@>==V9 A8AB5<V 70:C?V25;L ?V4 G0A ?>40==O B5=45@=>W ?@>?>78FVW5@5<>65FL =5 =040T ?V4B25@465==O A2>TW 2V4?>2V4=>ABV.8#G0A=8: ?@>F54C@8 70:C?V2;V 287=0=89 2 CAB0=>2;5=><C 70:>=>< ?>@O4:C 10=:@CB>< B0 AB>A>2=> =L>3> 2V4:@8B0 ;V:2V40FV9=0 ?@>F54C@0 (?V4?C=:B 8 ?C=:BC 47 A>1;82>AB59)#G0A=8: ?@>F54C@8 70:C?V2;V ?V4B25@46CT 2V4ACB=VABL ?V4AB028 H;OE>< A0<>ABV9=>3> 45:;0@C20==O 2V4ACB=>ABV B0:>W ?V4AB028 2 5;5:B@>==V9 A8AB5<V 70:C?V25;L ?V4 G0A ?>40==O B5=45@=>W ?@>?>78FVW5@5<>65FL =5 =040T ?V4B25@465==O A2>TW 2V4?>2V4=>ABV.9C 48=><C 45@602=><C @5TAB@V N@848G=8E >AV1, DV78G=8E >AV1 ?V4?@8T<FV2 B0 3@><04AL:8E D>@<C20=L 2V4ACB=O V=D>@<0FVO, ?5@5410G5=0 ?C=:B>< 9 G0AB8=8 4@C3>W AB0BBV 9 0:>=C #:@0W=8  @> 45@602=C @5TAB@0FVN N@848G=8E >AV1, DV78G=8E >AV1  ?V4?@8T<FV2 B0 3@><04AL:8E D>@<C20=L (:@V< =5@57845=BV2) (?V4?C=:B 9 ?C=:BC 47 A>1;82>AB59)#G0A=8: ?@>F54C@8 70:C?V2;V ?V4B25@46CT 2V4ACB=VABL ?V4AB028 H;OE>< A0<>ABV9=>3> 45:;0@C20==O 2V4ACB=>ABV B0:>W ?V4AB028 2 5;5:B@>==V9 A8AB5<V 70:C?V25;L ?V4 G0A ?>40==O B5=45@=>W ?@>?>78FVW5@5<>65FL =5 =040T ?V4B25@465==O A2>TW 2V4?>2V4=>ABV.10N@848G=0 >A>10, O:0 T CG0A=8:>< ?@>F54C@8 70:C?V2;V (:@V< =5@57845=BV2), =5 <0T 0=B8:>@C?FV9=>W ?@>3@0<8 G8 C?>2=>2065=>3> 7 @50;V70FVW 0=B8:>@C?FV9=>W ?@>3@0<8, O:I> 20@BVABL 70:C?V2;V B>20@C (B>20@V2), ?>A;C38 (?>A;C3) 01> @>1VB 4>@V2=NT G8 ?5@528ICT 20 <;=. 3@825=L (C B><C G8A;V 70 ;>B><) (?V4?C=:B 10 ?C=:BC 47 A>1;82>AB59)#G0A=8: ?@>F54C@8 70:C?V2;V ?V4B25@46CT 2V4ACB=VABL ?V4AB028 H;OE>< A0<>ABV9=>3> 45:;0@C20==O 2V4ACB=>ABV B0:>W ?V4AB028 2 5;5:B@>==V9 A8AB5<V 70:C?V25;L ?V4 G0A ?>40==O B5=45@=>W ?@>?>78FVW (;8H5 O:I> 20@BVABL 70:C?V2;V B>20@C (B>20@V2), ?>A;C38 (?>A;C3) 01> @>1VB 4>@V2=NT G8 ?5@528ICT 20 <V;L9>=V2 3@825=L (C B><C G8A;V 70 ;>B><))5@5<>65FL =5 =040T ?V4B25@465==O A2>TW 2V4?>2V4=>ABV.11CG0A=8: ?@>F54C@8 70:C?V2;V 01> :V=F5289 15=5DVFV0@=89 2;0A=8:, G;5= 01> CG0A=8: (0:FV>=5@) N@848G=>W >A>18 - CG0A=8:0 ?@>F54C@8 70:C?V2;V T >A>1>N, 4> O:>W 70AB>A>20=> A0=:FVN C 283;O4V 701>@>=8 =0 74V9A=5==O C =5W ?C1;VG=8E 70:C?V25;L B>20@V2, @>1VB V ?>A;C3 73V4=> V7 HYPERLINK "https://zakon.rada.gov.ua/laws/show/1644-18" \t "_blank" 0:>=>< #:@0W=8 @> A0=:FVW , :@V< 28?04:C, :>;8 0:B828 B0:>W >A>18 2 CAB0=>2;5=><C 70:>=>402AB2>< ?>@O4:C ?5@540=V 2 C?@02;V==O   (?V4?C=:B 11 ?C=:BC 47 A>1;82>AB59)#G0A=8: ?@>F54C@8 70:C?V2;V ?V4B25@46CT 2V4ACB=VABL ?V4AB028 H;OE>< A0<>ABV9=>3> 45:;0@C20==O 2V4ACB=>ABV B0:>W ?V4AB028 2 5;5:B@>==V9 A8AB5<V 70:C?V25;L ?V4 G0A ?>40==O B5=45@=>W ?@>?>78FVW5@5<>65FL =5 =040T ?V4B25@465==O A2>TW 2V4?>2V4=>ABV.125@V2=8:0 CG0A=8:0 ?@>F54C@8 70:C?V2;V, DV78G=C >A>1C, O:0 T CG0A=8:>< ?@>F54C@8 70:C?V2;V, 1C;> ?@8BO3=CB> 73V4=> V7 70:>=>< 4> 2V4?>2V40;L=>ABV 70 2G8=5==O ?@02>?>@CH5==O, ?>2 O70=>3> 7 28:>@8AB0==O< 48BOG>W ?@0FV G8 1C4L-O:8<8 D>@<0<8 B>@3V2;V ;N4L<8 (?V4?C=:B 12 ?C=:BC 47 A>1;82>AB59)#G0A=8: ?@>F54C@8 70:C?V2;V ?V4B25@46CT 2V4ACB=VABL ?V4AB028 H;OE>< A0<>ABV9=>3> 45:;0@C20==O 2V4ACB=>ABV B0:>W ?V4AB028 2 5;5:B@>==V9 A8AB5<V 70:C?V25;L ?V4 G0A ?>40==O B5=45@=>W ?@>?>78FVW5@5<>65FL ?@>F54C@8 70:C?V2;V =040T ?>2=89 28BO3 7 V=D>@<0FV9=>-0=0;VB8G=>W A8AB5<8 1;V: 2V4><>AB59 ?@> ?@8BO3=5==O >A>18 4> :@8<V=0;L=>W 2V4?>2V40;L=>ABV B0 =0O2=>ABV AC48<>ABV ?@> B5, I> :5@V2=8:0 CG0A=8:0 ?@>F54C@8 70:C?V2;V / DV78G=C >A>1C, O:0 T CG0A=8:>< 4> :@8<V=0;L=>W 2V4?>2V40;L=>ABV =5 ?@8BO3CTBLAO, =57=OB>W G8 =5?>30H5=>W AC48<>ABV =5 <0T B0 2 @>7HC:C =5 ?5@51C20T.130<>2=8: <>65 ?@89=OB8 @VH5==O ?@> 2V4<>2C CG0A=8:C ?@>F54C@8 70:C?V2;V 2 CG0ABV C 2V4:@8B8E B>@30E B0 <>65 2V4E8;8B8 B5=45@=C ?@>?>78FVN CG0A=8:0 ?@>F54C@8 70:C?V2;V 2 @07V, :>;8 CG0A=8: ?@>F54C@8 70:C?V2;V =5 28:>=02 A2>W 7>1>2 O70==O 70 @0=VH5 C:;045=8< 4>3>2>@>< ?@> 70:C?V2;N 7 F8< A0<8< 70<>2=8:><, I> ?@8725;> 4> 9>3> 4>AB@>:>2>3> @>7V@20==O, V 1C;> 70AB>A>20=> A0=:FVW C 283;O4V HB@0DV2 B0/01> 2V4H:>4C20==O 718B:V2  ?@>BO3>< B@L>E @>:V2 7 40B8 4>AB@>:>2>3> @>7V@20==O B0:>3> 4>3>2>@C.#G0A=8: ?@>F54C@8 70:C?V2;V, I> ?5@51C20T 2 >1AB028=0E, 707=0G5=8E C FL><C 0170FV, <>65 =040B8 ?V4B25@465==O 268BBO 70E>4V2 4;O 4>2545==O A2>TW =04V9=>ABV, =572060NG8 =0 =0O2=VABL 2V4?>2V4=>W ?V4AB028 4;O 2V4<>28 2 CG0ABV C 2V4:@8B8E B>@30E. ;O FL>3> CG0A=8: (AC1 T:B 3>A?>40@N20==O) ?>28=5= 4>25AB8, I> 2V= A?;0B82 01> 7>1>2 O702AO A?;0B8B8 2V4?>2V4=V 7>1>2 O70==O B0 2V4H:>4C20==O 70240=8E 718B:V2. /:I> 70<>2=8: 22060T B0:5 ?V4B25@465==O 4>AB0B=V<, CG0A=8:C ?@>F54C@8 70:C?V2;V =5 <>65 1CB8 2V4<>2;5=> 2 CG0ABV 2 ?@>F54C@V 70:C?V2;V (0170F 14 ?C=:BC 47 A>1;82>AB59)#G0A=8: ?@>F54C@8 70:C?V2;V <0T =040B8: 4>2V4:C 2 4>2V;L=V9 D>@<V ?@> B5, I> <V6 =8< V 70<>2=8:>< @0=VH5 =5 1C;> C:;045=> 4>3>2V@ ?@> 70:C?V2;N 70 O:8< CG0A=8: ?@>F54C@8 70:C?V2;V =5 28:>=02 A2>W 7>1>2 O70==O, I> ?@8725;> 4> 9>3> 4>AB@>:>2>3> @>7V@20==O, V 1C;> 70AB>A>20=> A0=:FVW C 283;O4V HB@0DV2 B0 / 01> 2V4H:>4C20==O 718B:V2  ?@>BO3>< B@L>E @>:V2 7 40B8 4>AB@>:>2>3> @>7V@20==O B0:>3> 4>3>2>@C; 01> CG0A=8: ?@>F54C@8 70:C?V2;V, I> ?5@51C20T 2 >1AB028=0E, 707=0G5=8E 2 0170FV 14 ?C=:BC 47 A>1;82>AB59, <>65 =040B8 ?V4B25@465==O 268BBO 70E>4V2 4;O 4>2545==O A2>TW =04V9=>ABV, =572060NG8 =0 =0O2=VABL 2V4?>2V4=>W ?V4AB028 4;O 2V4<>28 2 CG0ABV C 2V4:@8B8E B>@30E. ;O FL>3> 2V= ?>28=5= 4>25AB8, I> A?;0B82 01> 7>1>2 O702AO A?;0B8B8 2V4?>2V4=V 7>1>2 O70==O B0 2V4H:>4C20==O 70240=8E 718B:V2.5@5<>65FL =040T 4>2V4:C 2 4>2V;L=V9 D>@<V ?@> B5, I> <V6 =8< V 70<>2=8:>< =5 1C;> C:;045=> 4>3>2>@C ?@> 70:C?V2;N 70 O:8< ?5@5<>65FL ?@>F54C@8 70:C?V2;V =5 28:>=02 A2>W 7>1>2 O70==O, I> ?@8725;> 4> 9>3> 4>AB@>:>2>3> @>7V@20==O, V 1C;> 70AB>A>20=> A0=:FVW C 283;O4V HB@0DV2 B0/01> 2V4H:>4C20==O 718B:V2 - ?@>BO3>< B@L>E @>:V2 7 40B8 4>AB@>:>2>3> @>7V@20==O B0:>3> 4>3>2>@C 01> 5@5<>65FL ?@>F54C@8 70:C?V2;V, I> ?5@51C20T 2 >1AB028=0E, 707=0G5=8E 2 0170FV 14 ?C=:BV 47 A>1;82>AB59, <>65 =040B8 ?V4B25@465==O 268BBO 70E>4V2 4;O 4>2545==O A2>TW =04V9=>ABV, =572060NG8 =0 =0O2=VABL 2V4?>2V4=>W ?V4AB028 4;O 2V4<>28 2 CG0ABV C ?@>F54C@V 70:C?V2;V. ;O FL>3> 2V= ?>28=5= 4>25AB8, I> A?;0B82 01> 7>1>2 O702AO A?;0B8B8 2V4?>2V4=V 7>1>2 O70==O B0 2V4H:>4C20==O 70240=8E 718B:V2. V4AB028 4;O 2V4<>28 2 CG0ABV C ?@>F54C@V 70:C?V2;V * 5@5<>65FL ?@>F54C@8 70:C?V2;V C AB@>:, I> =5 ?5@528ICT G>B8@8 4=V 7 40B8 >?@8;N4=5==O 2 5;5:B@>==V9 A8AB5<V 70:C?V25;L ?>2V4><;5==O ?@> =0<V@ C:;0AB8 4>3>2V@ ?@> 70:C?V2;N, ?>28=5= =040B8 70<>2=8:C H;OE>< >?@8;N4=5==O 2 5;5:B@>==V9 A8AB5<V 70:C?V25;L 4>:C<5=B8, I> ?V4B25@46CNBL 2V4ACB=VABL ?V4AB02 4;O 2V4<>28 2 CG0ABV C ?@>F54C@V 70:C?V2;V. # @07V, O:I> ?5@5<>65FL ?@>F54C@8 70:C?V2;V =5 =0402 C A?>AV1, 707=0G5=89 2 B5=45@=V9 4>:C<5=B0FVW, 4>:C<5=B8, I> ?V4B25@46CNBL 2V4ACB=VABL ?V4AB02, CAB0=>2;5=8E ?C=:B>< 47 A>1;82>AB59, 01> =0402 4>:C<5=B8, O:V =5 2V4?>2V40NBL 28<>30<, 287=0G5=8< C B5=45@=V9 4>:C<5=B0FVW 01> =0402 WE 7 ?>@CH5==O< AB@>:V2, 287=0G5=8E A>1;82>ABO<8 70<>2=8: 2V4E8;OT 9>3> =0 ?V4AB02V 0170FC 3 ?V4?C=:BC 3 ?C=:BC 41 A>1;82>AB59, 0 A0<5: ?5@5<>65FL ?@>F54C@8 70:C?V2;V =5 =0402 C A?>AV1, 707=0G5=89 2 B5=45@=V9 4>:C<5=B0FVW, 4>:C<5=B8, I> ?V4B25@46CNBL 2V4ACB=VABL ?V4AB02, 287=0G5=8E ?C=:B>< 47 F8E >A>1;82>AB59. >40B>: 4 4> B5=45@=>W 4>:C<5=B0FVW -"%'  =0 70:C?V2;N 70 ?@54<5B>< 70:C?V2;V >B1- 8B@0B=V <0B5@V0;8 4> 35<0B>;>3VG=>3> 0=0;V70B>@0 Mindray BC 5000, BC 3000 plus >4  021:2015: 33690000-3 V:0@AL:V 70A>18 @V7=V (01>@0B>@=V @50:B828) ">20@ ?>28=5= 2V4?>2V40B8 =0ABC?=8< B5E=VG=8<, O:VA=8< B0 :V;L:VA=8< E0@0:B5@8AB8:0< !09<5=C20==O>4  024:2023548:> B5E=VG=V 28<>38  @07V ?>40GV 5:2V20;5=BC B>20@C, I> 70?@>?>=>20=89 0<>2=8:>< 2 <548:>-B5E=VG=8E 28<>30E, CG0A=8: ?>40T ?>@V2=O;L=C E0@0:B5@8AB8:C 70?@>?>=>20=>3> =8< B>20@C, I> 707=0G5=0 2 <548:>-B5E=VG=><C 70240==V 7 2V4><>ABO<8 I>4> 2V4?>2V4=>ABV 28<>30< 0<>2=8:0. %0@0:B5@8AB8:8 5:2V20;5=BC <0NBL 1CB8 =5 3V@H8<8 =V6 ?5@5410G5=> C<>20<8 FVTW B5=45@=>W 4>:C<5=B0FVW, 2 ?V4B25@465==O =0 :>6=89 =040=89 5:2V20;5=B CG0A=8: =040T V=AB@C:FVN 2 O:V9 1C45 707=0G5=> EV<VG=89 A:;04 6828;L=>3> A5@54>28I0/@5035=BC/@50:B82C (=040NBL CG0A=8:8 ?@>F54C@8 70:C?V2;V ?@8 ?>40GV 5:2V20;5=BC).4. 28<V@CV;L :VABL0B5@V0; :>=B@>;N 35<0B>;>3VG=89 0B5AB>20=89 1030B> ?0@0<5B@8G=89 Para 12 Extend: 1 x 2.5 <; (1 >@<0)55866 V4@0EC=>: :;VB8= :@>2V IVD (4V03=>AB8:0 in vitro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x 3.0 <;, =>@<055866 V4@0EC=>: :;VB8= :@>2V IVD (4V03=>AB8:0 in vitro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'8==0 45:;0@0FVO B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.HB5$0@1=8:-DV:A0B>@ ?> 09-@N=20;L4C, (@>7G8=) 42959 0@2=8: 09-@N=20;L40, IVD (4V03=>AB8:0 in vitro )V;L:VABL:=5 <5=H5 1000 <;.>2=VH=V9 283;O4:@V48=0 A8=L>-G5@2>=>3> :>;L>@C. 8?@>1C20==O =0 4V9A=VABL:48D5@5=FV0FVO D>@<5=8E 5;5<5=BV2 :@>2V. 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'8==0 45:;0@0FVO B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.HB5<5@AV9=0 @V48=0 4;O <V:@>A:>?VW, D; 100 <; 43550 $V:AC20;L=0 @V48=0 4;O <V:@>A:>?VW, IVD (4V03=>AB8:0 in vitro )"<5@AV9=0 @V48=0 4;O <V:@>A:>?VW ?@87=0G5=0 4;O 28:>@8AB0==O 2 O:>ABV 4>?><V6=>3> :><?>=5=B0 4;O <V:@>A:>?VG=8E <5B>4V2 4>A;V465==O 2 :;V=V:>-4V03=>AB8G=8E ;01>@0B>@VOE. !:;04 1. <5@AV9=0 @V48=0 4;O <V:@>A:>?VW 1 D; - 100 ml (<;). '8==0 45:;0@0FVO B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.D;15>=>:;>=0;L=89 @5035=B 0=B8- 4;O 287=0G5==O 3@C? :@>2V ;N48=8 70 A8AB5<>N 052532 =B8-A 3@C?>25 B8?C20==O 5@8B@>F8BV2 IVD (4V03=>AB8:0 in vitro ), 0=B8BV;0. @87=0G5=89 4;O 287=0G5==O 3@C? :@>2V ;N48=8 H;OE>< 28O2;5==O 0=B835=C  5@8B@>F8BV2 ;N48=8 70 4>?><>3>N @50:FVW ?@O<>W 35<03;NB8=0FVW. =0;VB8G=V E0@0:B5@8AB8:8 5035=B8 AB@>3> A?5F8DVG=V. 1. VAB8BL <>=>:;>=0;L=V 0=B8BV;0 0=B8- :;0AC Ig M 2 B8B@V e" 1:32, =5 ?>28=5= 4020B8 03;NB8=0FVW 7 5@8B@>F8B0<8 3@C? (III) V 0(I). 8O2;OT 1 V 2 0=B835=8 5@8B@>F8BV2. 3;NB8=0FVO 5@8B@>F8BV2 7 1V;LH A;01:8<8 20@V0=B0<8 0=B835=C  =0AB0T ?V7=VH5, =V6 7 5@8B@>F8B0<8 1 V 2. 2. 5<03;NB8=CNG0 0:B82=VABL =0 ?;>I8=V <>=>:;>=0;L=>3> @5035=BC 0=B8- - =5 ?V7=VH5 10 s (A).3. V4B2>@N20=VABL @57C;LB0BV2 A:;040T 100%. '8==0 45:;0@0FVO B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N. D;2>=>:;>=0;L=89 @5035=B 0=B8- 4;O 287=0G5==O 3@C? :@>2V ;N48=8 70 A8AB5<>N 052538 =B8-B 3@C?>25 B8?C20==O 5@8B@>F8BV2 IVD (4V03=>AB8:0 in vitro ), 0=B8BV;0. @87=0G5=89 4;O 287=0G5==O 3@C? :@>2V ;N48=8 70 A8AB5<>N 0 ?@87=0G5=89 4;O 287=0G5==O 3@C? :@>2V ;N48=8 H;OE>< 28O2;5==O 0=B835=C  5@8B@>F8BV2 ;N48=8 70 4>?><>3>N @50:FVW ?@O<>W 35<03;NB8=0FVW =0;VB8G=V E0@0:B5@8AB8:8 5035=B8 AB@>3> A?5F8DVG=V. 1. VAB8BL <>=>:;>=0;L=V 0=B8BV;0 0=B8- :;0AC Ig M 2 B8B@V e" 1:32, =5 ?>28=5= 4020B8 03;NB8=0FVW 7 5@8B@>F8B0<8 3@C? (II) V 0(I). 2. 5<03;NB8=CNG0 0:B82=VABL =0 ?;>I8=V <>=>:;>=0;L=>3> @5035=BC 0=B8- - =5 ?V7=VH5 10 s (A).3. V4B2>@N20=VABL @57C;LB0BV2 A:;040T 100%. '8==0 45:;0@0FVO B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N. D;2>=>:;>=0;L=89 @5035=B 0=B8-D !C?5@ 4;O 287=0G5==O 3@C? :@>2V ;N48=8 70 A8AB5<>N Rhesus52647 =B8-Rh(D) 3@C?>25 B8?C20==O 5@8B@>F8BV2 IVD, (4V03=>AB8:0 in vitro ), 0=B8BV;0@87=0G5=89 4;O 287=0G5==O 3@C? :@>2V ;N48=8 70 A8AB5<>N Rhesus 70AB>A>2CTBLAO 4;O 2AB0=>2;5==O @57CA =0;56=>ABV C >AV1 1C4L-O:>W 3@C?>2>W ?@8=0;56=>ABV 70 A8AB5<>N 0. =0;VB8G=V E0@0:B5@8AB8:8 5035=B AB@>3> A?5F8DVG5=. 1.VAB8BL <>=>:;>=0;L=V 0=B8BV;0 0=B8-D :;0AC Ig  2 B8B@V e" 1:32 2. 5<03;NB8=CNG0 0:B82=VABL =0 ?;>I8=V - =5 ?V7=VH5 60 s (A) 0T 28A>:C 35<03;NB8=CNGC 0:B82=VABL V =04V9=> 28O2;OT 2V4?>2V4=89 0=B835= =0 5@8B@>F8B0E O: 3><>-, B0: V 35B5@>783>B=8E D5=>B8?V2 (2 ?@O<V9 @50:FVW =0 ?;>I8=V). !?5F8DVG5= V =5 40T ?5@5E@5A=8E @50:FV9 7 =52V4?>2V4=8<8 0=B835=0<8. V4B2>@N20=VABL @57C;LB0BV2 A:;040T 100%. '8==0 45:;0@0FVO B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.D;2TPHA - B5AB 51819 Treponema pallidum reagin antibody IVD (4V03=>AB8:0 in vitro ), =01V@, @50:FVO 03;NB8=0FVW"V03=>AB8:C< 4;O 28O2;5==O 0B8BV; 4> 1;V4>W A?V@>E5B8 2 A8@>20BFV B0 ?;07<V :@>2V ;N48=870 @50:FVTN =5?@O<>W 35<03;NB8=0FVW !:;04 =01>@C 1. 5035=B 1. "5AB>2V :;VB8=8. @8B@>F8B8 ?B8FV A5=A81V;V7>20=V 0=B835=>< T.pallidum.2. 5035=B 2. >=B@>;L=V :;VB8=8. @8B@>F8B8 ?B8FV.3. 5035=B 3. >7G8==8:. $>AD0B=89 1CD5@, 5:AB@0:B T. Pallidum (Reiter).4. 5035=B 4. >78B82=89 :>=B@>;L. <C==0 ;N4AL:0 A8@>20B:0 @>72545=0 1:20.5. 5035=B 5. 530B82=89 :>=B@>;L.6. V:@>?;0=H5B 4;O B8B@C20==O 7 U-4=><. '8==0 45:;0@0FVO B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.HB1!C;LD>A0;VF8;>20 :8A;>B0, '62707 07>289 :><?>=5=B 6828;L=>3> A5@54>28I0 IVD (4V03=>AB8:0 in vitro )%V<VG=0 D>@<C;0 HO3S(HO)C6H3COOH2H2O 20;VDV:0FVO G40 !B0=40@B O:>ABV " 0B0 283>B>2;5==O 04.2023 @. 0@0=BV9=89 B5@<V= 715@V30==O 4 @>:8 0@BVO 3126 8@>1=8: =4VO . 1. 0A>20 4>;O >A=>2=>W @5G>28=8, % 99,0 100,1 2. V;L=0 :8A;>B0, % 5,5 4,56 3. >;>3VABL, % 22 V4?>2V40T 4. @>7>@VABL 20 % 2>4=89 @>7G8= ?@>7>@89 B0 157 :>;L>@C. !5@B8DV:0B O:>ABV B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.:30,20B@V9 ;8<>==>:8A;89 3 70AB. 2-2>4=89, D0@<62707 07>289 :><?>=5=B 6828;L=>3> A5@54>28I0 IVD (4V03=>AB8:0 in vitro )%V<VG=0 D>@<C;0 C6H5O7Na3 2H2O 20;VDV:0FVO D0@< !B0=40@B O:>ABV FCC3 0B0 283>B>2;5==O 01.2023 @. 0@0=BV9=89 B5@<V= 715@V30==O 3 @>:8 0@BVO S32301019 8@>1=8: 8B09. 1 0A>20 G0AB:0 >A=>2=>W @5G>28=8, % 99,0  101,0 100,4 2 8A;>B=VABL V4?>2V40T V4?>2V40T 3 !C;LD0B8 (SO4), % d" 0,015 < 0,015 4 06:V <5B0;8 (Pb), % d" 0,001 < 0,001 5 :A0;0B8, % d" 0,03 < 0,03 6 5G>28=8, 740B=V 4> :0@1>=V70FVW V4?>2V40T. 7 %;>@848 (Cl), % d" 0,005 < 0,005 8 B@0B8 ?@8 28ACHC20==V, % 11,0-13,0 12,31 9 >2=VH=V9 283;O4 V;V :@8AB0;8 V;V :@8AB0;8. !5@B8DV:0B O:>ABV B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.:32,1 $-;0B5:A-B5AB55112 52<0B>W4=89 G8==8: IVD (4V03=>AB8:0 in vitro ), =01V@, @50:FVO 03;NB8=0FVWV03=>AB8:C< 4;O 28O2;5==O @52<0B>W4=>3> D0:B>@C 2 A8@>20BFV :@>2V ;N48=8 <5B>4>< ;0B5:A=>W 03;NB8=0FVW. !:;04 =01>@C 1. 5035=B 1. 0B5:A=0 ACA?5=7VO, 2 ml (<;) (1 HB.) 2. 5035=B 2. >7G8==8:, 14 ml (<;) (1 HB.)3. 5035=B 3. >78B82=89 :>=B@>;L, O:89 <VAB8BL $ 1V;LH 12 IU/ml (4/<;), 0.2 ml (<;) (1 HB.)4. 5035=B 4. 530B82=89 :>=B@>;L, O:89 <VAB8BL $ <5=H 12 IU/ml (4/<;), 0.2 ml (<;) (1 HB.)5. 0;8G:8 4;O ?5@5<VHC20==O (100 HB.)6. "5AB>289 A;094 (2 HB.) =0;VB8G=V E0@0:B5@8AB8:8 'CB;82VABL B5ABC AB0=>28BL 12 IU/ml (4/<;) (03;NB8=0FVO =0 2+). !B0=40@B870FVO 28:>=0=0 ?> <V6=0@>4=><C AB0=40@BC $ NIBSC 64/002. '8==0 45:;0@0FVO B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.HB2! -;0B5:A-B5AB63234 C-@50:B82=89 1V;>: (CRP) IVD (4V03=>AB8:0 in vitro ), =01V@, 03;NB8=0FVO, 5:A?@5A-0=0;V7"V03=>AB8:C< 4;O 28O2;5==O !-@50:B82=>3> 1V;:C 2 A8@>20BFV :@>2V ;N48=8 <5B>4>< ;0B5:A=>W 03;NB8=0FVW !:;04 =01>@C 1. 5035=B 1. 0B5:A=0 ACA?5=7VO, 2 ml (<;) (1 HB.) 2. 5035=B 2. >7G8==8:, 14 ml (<;) (1 HB.)3. 5035=B 3. >78B82=89 :>=B@>;L, O:89 <VAB8BL !  1V;LH 6 mg/l (<3/;), 0.2 ml (<;) (1 HB.)4. 5035=B 4. 530B82=89 :>=B@>;L, O:89 <VAB8BL !  <5=H 6 mg/l (<3/;), 0.2 ml (<;) (1 HB.)5. 0;8G:8 4;O ?5@5<VHC20==O (100 HB.)6. "5AB>289 A;094 (2 HB.) =0;VB8G=V E0@0:B5@8AB8:8 'CB;82VABL B5ABC AB0=>28BL 6 mg/l (<3/;) (03;NB8=0FVO =0 2+). !B0=40@B870FVO 28:>=0=0 ?> @5D5@5=A=><C <0B5@V0;C ERM-DA 474/IFCC. '8==0 45:;0@0FVO B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.HB2!--;0B5:AB5AB63271 5B0-35<>;VB8G=0 G8A;5==0 3@C?0 AB@5?B>:>:V2 AB@5?B>;V78= O, 0=B8BV;0 IVD (4V03=>AB8:0 in vitro ), =01V@, 03;NB8=0FVOV03=>AB8:C<C 4;O 28O2;5==O 0=B8AB@5?B>;V78=C- 2 A8@>20BFV :@>2V ;N48=8 <5B>4>< ;0B5:A=>W 03;NB8=0FVW !:;04 =01>@C 1. 5035=B 1. 0B5:A=0 ACA?5=7VO, 2 ml (<;) (1 HB.) 2. 5035=B 2. >7G8==8:, 14 ml (<;) (1 HB.)3. 5035=B 3. >78B82=89 :>=B@>;L, O:89 <VAB8BL ! 1V;LH 200 IU/ml (4/(<;), 0.2 ml (<;) (1 HB.)4. 5035=B 4. 530B82=89 :>=B@>;L, O:89 <VAB8BL ! <5=H 200 IU/ml (4/<;), 0.2 ml (<;) (1 HB.)5. 0;8G:8 4;O ?5@5<VHC20==O (100 HB.) 6. 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024:2023: 43853 V>DV;V70B>@ ;01>@0B>@=89D;3011>=B@>;L Spinchem =>@<0 !4 5 <; 024:2023: 43853 V>DV;V70B>@ ;01>@0B>@=89D;3012C;LB8:0;V1@0B>@ Monlab  024:2023: 43853 V>DV;V70B>@ ;01>@0B>@=89D;413>=B@>;L Monlab 5 <;  024:2023: 43853 V>DV;V70B>@ ;01>@0B>@=89D;3014"@83;VF5@848 60 Cormay  024:2023: 53462 "@83;VF5@848 IVD (4V03=>AB8:0 in vitro), @5035=BHB215!5G>20 :8A;>B0 60 Cormay  024:2023: 53583 !5G>20 :8A;>B0 IVD (4V03=>AB8:0 in vitro), =01V@, D5@<5=B=89 A?5:B@>D>B><5B@8G=89 0=0;V7HB216@50B8=:V=070 Cormay  024:2023: 53001 030;L=0 :@50B8=:V=070 IVD (4V03=>AB8:0 in vitro), =01V@, D5@<5=B=89 A?5:B@>D>B><5B@8G=89 0=0;V7HB117@50B8=V= AB0=40@B Cormay  024:2023: 53251 @50B8=V= IVD (4V03=>AB8:0 in vitro), =01V@, A?5:B@>D>B><5B@8G=89 0=0;V7HB218!5G>28=0 AB0=40@B Cormay  024:2023: 30209 01V@ @5035=BV2 4;O 28<V@N20==O A5G>28=8 IVD (4V03=>AB8:0 in vitro), V>==>-A5;5:B82=89 5;5:B@>4 (ISE)HB219!5G>20 :8A;>B0 AB0=40@B Cormay  024:2023: 53583 !5G>20 :8A;>B0 IVD (4V03=>AB8:0 in vitro), =01V@, D5@<5=B=89 A?5:B@>D>B><5B@8G=89 0=0;V7HB220%>;5AB5@8=  Cormay  024:2023: 59058 89=89/>G8IC20;L=89 @>7G8= IVD (4V03=>AB8:0 in vitro) 4;O 02B><0B87>20=8E/ =0?V202B><0B87>20=8E A8AB5<HB121@><82=89 @-= 4;O :N25B Rinse 1; 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'8==0 45:;0@0FVO B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.HB1 >B 5 28B@0B=V <0B5@V0;8 4;O <V:@>1V>;>3VW >4  021:2015: 33690000-3 V:0@AL:V 70A>18 @V7=V (01>@0B>@=V @50:B828) ">20@ ?>28=5= 2V4?>2V40B8 =0ABC?=8< B5E=VG=8<, O:VA=8< B0 :V;L:VA=8< E0@0:B5@8AB8:0< !09<5=C20==O>4  024:2019548:> B5E=VG=V 28<>38  @07V ?>40GV 5:2V20;5=BC B>20@C, I> 70?@>?>=>20=89 0<>2=8:>< 2 <548:>-B5E=VG=8E 28<>30E, CG0A=8: ?>40T ?>@V2=O;L=C E0@0:B5@8AB8:C 70?@>?>=>20=>3> =8< B>20@C, I> 707=0G5=0 2 <548:>-B5E=VG=><C 70240==V 7 2V4><>ABO<8 I>4> 2V4?>2V4=>ABV 28<>30< 0<>2=8:0. %0@0:B5@8AB8:8 5:2V20;5=BC <0NBL 1CB8 =5 3V@H8<8 =V6 ?5@5410G5=> C<>20<8 FVTW B5=45@=>W 4>:C<5=B0FVW, 2 ?V4B25@465==O =0 :>6=89 =040=89 5:2V20;5=B CG0A=8: =040T V=AB@C:FVN 2 O:V9 1C45 707=0G5=> EV<VG=89 A:;04 6828;L=>3> A5@54>28I0/@5035=BC/@50:B82C (=040NBL CG0A=8:8 ?@>F54C@8 70:C?V2;V ?@8 ?>40GV 5:2V20;5=BC).4. 28<V@CV;L :VABL$5=>;, G 62707 -07>289 :><?>=5=B 6828;L=>3> A5@54>28I0 IVD (4V03=>AB8:0 in vitro )%V<VG=0 D>@<C;0 C6H6O 20;VDV:0FVO G !B0=40@B O:>ABV " 0B0 283>B>2;5==O 08.2022 @. 0@0=BV9=89 B5@<V= 715@V30==O 5 @>:V2 0@BVO 900822 8@>1=8: =4VO. 1. 0A>20 G0AB:0 >A=>2=>W @5G>28=8, %, =5 <5=H5 99,0 99,97 2. "5<?5@0BC@0 ?;02;5==O, ! 38 - 42 40,8 3. 0;8H>: ?VA;O 28?0@N20==O, % =5 1V;LH5 0,01 0,005 4. >40, % =5 1V;LH5 0,5 0,0056 5. %;>@848 (Cl), %, =5 1V;LH5 0,001 0,0004 6. 0;V7> (Fe), %, =5 1V;LH5 0,0001 0,0001. !5@B8DV:0B O:>ABV B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.:310B@V9 3V4@>:A84 4@V1=>3@0=C;L>20=89, EG62707 -07>289 :><?>=5=B 6828;L=>3> A5@54>28I0 IVD (4V03=>AB8:0 in vitro )0B@V9 3V4@>>:8A (4@V1=>3@0=C;L>20=89) %V<VG=0 D>@<C;0 NaOH 20;VDV:0FVO EG !B0=40@B O:>ABV " 0B0 283>B>2;5==O 08.2023 @. 0@0=BV9=89 B5@<V= 715@V30==O 2 @>:8 0@BVO 14322 8@>1=8: A?0=VO. 1 0A>20 G0AB:0 >A=>2=>W @5G>28=8, , 3/:3 > 99,0 2 C3;5:8A;89 =0B@V9 (Na2CO3), 3/:3 < 4,0 3 Na2SO4, <3/:3 < 80,0 4 NaCl, <3/:3 < 200,0 5 0;V7> (Fe), <3/:3 < 10,0 6 VH*O: (As), <3/:3 < 2 7 04<V9 (Cd), <3/:3 d" 1 8 %@>< (Cr), <3/:3 d" 1 9 !C@<0 (Sb), <3/:3 d" 5 10 BCBL (Hg), ppm < 0,1 11 !28=5FL (Pb), <3/:3 < 0,5 12 !5;5= (Se), <3/:3 d" 5 13 >2;5==O =5@>7G8==V C 2>4V, ppm !>>B2. 14 @30=VG=V 4><VH:8, ppm !?V22V4. 15 V:5;L (Ni), <3/:3 d" 2. !5@B8DV:0B O:>ABV B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.:3205B8;5=>289 A8=V9 2>4>@>7G8==89 , C? 100362707 -07>289 :><?>=5=B 6828;L=>3> A5@54>28I0 IVD (4V03=>AB8:0 in vitro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V4BV=>: V4?>2V40T AB0=40@BC. !5@B8DV:0B O:>ABV B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.:30,1010@2;5==O 70 &V;5<-V;LA5=><42694-0@2=8: 4;O :8A;>B>ABV9:8E 10:B5@V9, =01V@, IVD!  # 1. 0@1>;>289 @>7G8= DC:A8=C - 1 D;0:>= 7 (100 4) <;; 2. =510@2;NNG89 @>7G8= 1 - 1 D;0:>= 7 (100 4) <;; 3. =510@2;NNG89 @>7G8= 2 - 1 D;0:>= 7 (100 4) <;; 4. >7G8= <5B8;5=>2>3> A8=L>3> - 1 D;0:>= 7 (100 4) <;. "' % " !" 01V@ @>7@0E>20=89 =0 ?@>2545==O 200 0=0;V7V2 (?@8 28B@0BV @>7G8=V2 @5035=BV2 0,5 <; =0 287=0G5==O). '8==0 45:;0@0FVO ?@> 2V4?>2V4=VABL, V=AB@C:FVO =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. V4?>2V4=VABL B5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro.=01V@20!5@54>28I5 5AA5;O ,C? 10061627- 30@ 4;O Enterobacteriaceae, 6828;L=5 A5@54>28I5 IVD (4V03=>AB8:0 in vitro )!5;5:B82=89 V/01> 48D5@5=FV9=89 030@, 6828;L=5 A5@54>28I5, ?@87=0G5=89 4;O 28@>IC20==O B0 48D5@5=FV0FVW :>;VD>@<=8E 10:B5@V9 (coliform bacteria) V Enterobacteriaceae 7 :;V=VG=>3> 7@07:0 7 28:>@8AB0==O< D5@<5=B0FVW ;0:B>78 (lactose) V/01> A0E0@>78 (sucrose). 0728G09 C A:;04V T D0@1C20;L=V :><?>=5=B8 [=0?@8:;04, 5>78= 7 <5B8;5=>28< A8=V< (eosin methylene blue (EMB)), DC:A8=, AC;LDVB (fuchsin sulphite (Endo)), :@8AB0;VG=89 DV>;5B>289 (crystal violet) V 1@><B8<>;>289 A8=V9 (bromothymol blue (Drigalski) )], O:V ?@83=VGCNBL @VAB 3@0<?>78B82=8E 10:B5@V9; O: =0A;V4>: 2V41C20TBLAO D0@1C20==O 030@C V/01> :>;>=V9. '8==0 45:;0@0FVO ?@> 2V4?>2V4=VABL, V=AB@C:FVO =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. V4?>2V4=VABL B5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro.:30,1&8B@0B=89 030@ !8<<>=A0 ,C? 100358669 &8B@0B=89 030@ !V<<>=A0 4;O Enterobacteriacae, 6828;L=5 A5@54>28I5 IVD (4V03=>AB8:0 in vitro)$0AC20==O: 10=:0 0,25 :3 8D5@5=FV0FVO 5=B5@>10:B5@V9 70 740B=VABN D5@<5=BC20B8 F8B@0B. 65@5;> 2C3;5FN C A5@54>28IV T F8B@0B C 283;O4V =0B@VT2>W A>;V. 024O:8 FL><C A5@54>28I5 A?@8OT @>ABC ;8H5 F8B@0B-?>78B82=8E <V:@>>@30=V7<V2. @8 WE @>728B:C ?@>4C:B8 68BBT4VO;L=>ABV ?V428ICNBL @, I> 28O2;OTBLAO 7<V=>N :>;L>@C V=48:0B>@0 (1@>< B8<>;>289 A8=V9) 7 75;5=>3> =0 A8=V9. '8==0 45:;0@0FVO ?@> 2V4?>2V4=VABL, V=AB@C:FVO =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. V4?>2V4=VABL B5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro.:30,1!5@54>28I5 VAA0 7 ;0:B>7>N, C? 100 336220 V:@>1=89 @5035=B 7 28:>@8AB0==O< ;0:B>78 IVD (4V03=>AB8:0 in vitro)$0AC20==O: 10=:0 0,1 :3. @87=0G5=89 4;O 28:>@8AB0==O 2 <V:@>1=8E B5AB0E, I>1 287=0G8B8 740B=VABL <V:@>>@30=V7<C, 284V;5=>3> 7 :;V=VG=>3> 7@07:0 70 4>?><>3>N :C;LBC@8, 4> D5@<5=B0FVW 2C3;52>4=>W ;0:B>78. '8==0 45:;0@0FVO ?@> 2V4?>2V4=VABL, V=AB@C:FVO =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. V4?>2V4=VABL B5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro.:30,1!5@54>28I5 VAA0 7 <0;LB>7>N , C? 100 338667 5035=B 4;O <V:@>1V>;>3VG=>3> B5ABC=0 A?>6820==O <0;LB>78 IVD (4V03=>AB8:0 in vitro )$0AC20==O: 10=:0 0,1 :3 @87=0G5=89 4;O 28:>@8AB0==O 2 <V:@>1V>;>3VG=><C B5ABV =0 287=0G5==O 740B=>ABV <V:@>>@30=V7<V2, 284V;5=8E V7 :;V=VG=>3> 7@07:0 :C;LB82C20==O<, D5@<5=BC20B8 2C3;52>4 <0;LB>7C (maltose).'8==0 45:;0@0FVO ?@> 2V4?>2V4=VABL, V=AB@C:FVO =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. V4?>2V4=VABL B5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro.:30,1!5@54>28I5 VAA0 7 3;N:>7>N , C? 100342734 5035=B 4;O ?@>2545==O <V:@>1V>;>3VG=>3> B5ABC =0 287=0G5==O 45:AB@>78, IVD (4V03=>AB8:0 in vitro )$0AC20==O: 10=:0 0,1 :3 @87=0G5=89 4;O 28:>@8AB0==O 2 <V:@>1V>;>3VG=><C B5ABV =0 287=0G5==O 740B=>ABV <V:@>>@30=V7<V2, 284V;5=8E V7 :;V=VG=>3> 7@07:0 :C;LB82C20==O<, D5@<5=BC20B8 2C3;52>4 45:AB@>7C (dextrose).'8==0 45:;0@0FVO ?@> 2V4?>2V4=VABL, V=AB@C:FVO =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. V4?>2V4=VABL B5E=VG=><C @53;0<5=BC I>4> <548G=8E 28@>1V2 4;O 4V03=>AB8:8 in vitro:30,1!5@54>28I5 VAA0 7 A>@1VB>< , C? 100334325 5035=B 4;O <V:@>1V>;>3VG=>3> B5ABC =0 A?>6820==O A>@1VB>;C IVD (4V03=>AB8:0 in vitro )$0AC20==O: 10=:0 0,1 :3 @87=0G5=89 4;O 28:>@8AB0==O 2 <V:@>1V>;>3VG=><C B5ABV =0 287=0G5==O 740B=>ABV <V:@>>@30=V7<V2, 284V;5=8EV 7 :;V=VG=>3> 7@07:0 :C;LB82C20==O<, D5@<5=BC20B8 A>@1VB>; (sorbitol). 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" :A0;0B8 (%)  2V4?>2V40NBL B5ABC. 8@>1=8FB2>  8B09.!5@B8DV:0B O:>ABV B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.:30,5;VF5@8= D0@<0:>?59=89 E0@G>289 1;62707 -07>289 :><?>=5=B 6828;L=>3> A5@54>28I0 IVD (4V03=>AB8:0 in vitro )20;VDV:0FVO D0@< %V<VG=0 D>@<C;0 C3H8O3 !B0=40@B O:>ABV " 0B0 283>B>2;5==O 09.2023@. 0@0=BV9=89 B5@<V= 715@V30==O 2 @>:8 0@BVO 121-Y 8@>1=8: '5EVO. 1 <VAB 3;VF5@8=C, % 99,5 - 100,0 99,6 2 >40, % 0,0 - 0,5 0,1 3 >;V@, Alpha 0 - 10 6 4 <VAB 30;>35==8E @5G>28=, % d" 35 < 35 5 06:V <5B0;8 (Pb), <3/:3 < 5 < 5 6 45=B8DV:0FVO @5D@0:FVW, nD20 1,470-1,475 1,474 7 8A;>B=VABL (0.1 mol NaOH/10ml), <; d" 0,2 0,11 8 !C;LD0BV, % d" 0,01 0,004 9 %;>@84V, <3/:3 d" 10 < 10 10 DV@V, <; HCl 0.1 N > 8,0 8,6 11 ;L453V4V, % d" 10 < 10 12 >2=VH=V9 283;O4 @>7G8=C @>7>@0 @V48=0 @>7>@0 @V48=0 13 0?0E 57 70?0EC V4?>2V40T.!5@B8DV:0B O:>ABV B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.:3303=V9 AV@G0=>:8A;89 7-2>4=89 , C? 100362707 -07>289 :><?>=5=B 6828;L=>3> A5@54>28I0 IVD (4V03=>AB8:0 in vitro )1 <VAB 3;VF5@8=C, % 99,5 - 100,0 99,6 2 >40, % 0,0 - 0,5 0,1 3 >;V@, Alpha 0 - 10 6 4 <VAB 30;>35==8E @5G>28=, % d" 35 < 35 5 06:V <5B0;8 (Pb), <3/:3 < 5 < 5 6 45=B8DV:0FVO @5D@0:FVW, nD20 1,470-1,475 1,474 7 8A;>B=VABL (0.1 mol NaOH/10ml), <; d" 0,2 0,11 8 !C;LD0BV, % d" 0,01 0,004 9 %;>@84V, <3/:3 d" 10 < 10 10 DV@V, <; HCl 0.1 N > 8,0 8,6 11 ;L453V4V, % d" 10 < 10 12 >2=VH=V9 283;O4 @>7G8=C @>7>@0 @V48=0 @>7>@0 @V48=0 13 0?0E 57 70?0EC V4?>2V40T.!5@B8DV:0B O:>ABV B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.:30,50B@V9 D>AD>@=>:8A;89 2-E 70<VI5=89 ,C? 100362707 -07>289 :><?>=5=B 6828;L=>3> A5@54>28I0 IVD (4V03=>AB8:0 in vitro )=0;V7 (1572>4=89) >99,9 % 98,0 471ME035 As <0,02 ppm 1 1,0 471ME047 0A8?=0 IV;L=VABL 0,98 3/A< 0,70 1,10 471ME001 Cd <1,0 ppm 1 1,0 471ME110 $B>@ <1,0 ppm 1 10,0 476ME008 Hg <0,01 ppm 1 0,1 471ME049 5@>7G8==0 H2O 0,03 % 0,20 471ME100 B@0B8 ?@8 28A8E0==V ?@8 120C 0,03 % 0,50 471ME020 P2O5 (1572>4=89) 50,1 % 49,5 51,0 471ME029 Pb <1,0 ppm 1 1,0 471ME110 V@>D>AD0B (Na4P2O7) 0,2 % 2,0 471ME033 pH 1% 9,1 8,4 9,3 471ME01. !5@B8DV:0B O:>ABV B0 V=AB@C:FVO ?@> 2V4?>2V4=VABL =040TBLAO C A:;04V ?@>?>78FVW 45@602=> <>2>N. 0@:C20==O 5B8:5B:8 73V4=> 28<>3 G8==>3> 70:>=>402AB20 B0 C:@0W=AL:>N <>2>N.:320B@V9 D>AD>@=>:8A;89 1 70<VI5=89 ,C? 100 362707 -07>289 :><?>=5=B 6828;L=>3> A5@54>28I0 IVD (4V03=>AB8:0 in vitro )%V<VG=0 D>@<C;0 NaH2PO4 20;VDV:0FVO W6 !B0=40@B O:>ABV " 0B0 283>B>2;5==O 02.2023 3 0@0=BV9=89 B5@<V= 715@V30==O 2 @>:8 0@BVO 23031803 8@>1=8: 8B09. 1. @ (1%-=>3> @>7G8=C) 4,3 - 4,7 4,7 2. 0A>20 G0AB:0 >A=>2=>W @5G>28=8, % 98,0 99,9 3. 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