qc rp kits (mid kfsh d)

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Medical Imaging Department

Nuclear Medicine Section

Radiopharmaceutical QA Program

NML-4

99m

Tc-HDP

Procedure:

System I: ITLC-SG / Acetone (HPLC grade)

System II: ITLC-SG / Saline (0.! "aCl)

#$ere%

% Pertechnetate (99mTcO4-) & ! acti'ity at t$e sol'ent ront in System I.

% Reduced-hydrolyzed Tc (99mTcO2-) & ! acti'ity remaining at t$e origin in System

II

% 99mTc-HDP & (! acti'ity at t$e sol'ent ront in System II) - ! Pertec$netate

(mTc*-) or%

& (! acti'ity remaining at t$e origin in System I) - ! +ed,ced-

$ydrolyed Tc (mTc-).

Results:

% 99mTc-HDP = 100 (%99mTcO4- ! %99mTcO2-)






NML-4

99mTc-HDP

Date " Pre#arat$on t$me "

$al lot no " &'#$re date:

Reult %RP PH +adio$armacist

*ytem %Pur$ty %+m#ur$ty

1

2



Reult %RP PH


1

2



Reult %RP PH ,##roal .y


1

2





1

2






NM2

99mTc-D/*, Procedure:System I: ITLC-SG / et$yl 1t$yl 2eton (12)


#$ere%

% Pertechnetate (

99m

TcO4

-

) & ! acti'ity at t$e sol'ent ront in System I.% Reduced-hydrolyzed Tc (99mTcO2-) & ! acti'ity remaining at t$e origin in System

II

% 99mTc-D/*, & (! acti'ity at t$e sol'ent ront in System II) - ! Pertec$netate

(mTc*-) or%



Results:

% 99mTc-D/*, = 100 (%99mTcO4- ! %99mTcO2-)






NM2

99m

Tc-D/*,





1

2





1

2





1

2





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2






NM3

99m

Tc-DTP, Procedure:System I: ITLC-SG / et$yl 1t$yl 2eton(12)


#$ere%



II

% 99mTc-DTP, & (! acti'ity at t$e sol'ent ront in System II) - ! Pertec$netate

(mTc*-) or%



Results:

% 99mTc-DTP, = 100 (%99mTcO4- ! %99mTcO2-)






NM3

99mTc-DTP,





1

2





1

2





1

2





1

2






NM5

99mTc-H+D, der$at$e

Procedure:Com3ination 3et4een t4o systems 4as ,sed or !+CP determination (UKRG, 2002)

as a modiication o t$e standard met$od introd,ced 3y Nunn et al (1983).

System I: #$atman 5 / 12 (6,tanone)

System II: ITLC-SG / 70! Acetonitril

N.B. The spotted sample in system I should be dried with a hot air stream or in an

oven with a temperature less than 50 0C (in higher temperature the sample may be

damaged) before developing the strip in the solvent.

#$ere%

% Pertechnetate (99mTcO4-) & ! acti'ity at t$e sol'ent ront in System I (+ & 0.).


II

% 99mTc-+D, & (! acti'ity at t$e sol'ent ront in System II) - ! Pertec$netate

(mTc*

Results:

% 99mTc-+D, = 100 (%99mTcO4- ! %99mTcO2-)






NM5

99mTc-H+D, der$at$eDate " Pre#arat$on t$me "




1

2





1

2





1

2





1

2






NM6

99mTc-H/P,O Procedure:

+CP 4ere o3tained t$ro,g$ a com3ination o t$ree c$romatogra$ic systems t$at

allo4 t$e ,ll 8,antitati'e assessment o t$e radioc$emical comosition o t$e

mi9t,re.

T$ese systems are:

ITLC-SG / saline ("aCl) system

ITLC-SG / et$yl-et$yl eton

#$atman no.; / 70! Acetonitril: 70! H

T$en% ,sing t$ese t$ree c$romatogra$ic systems% t$e c$emical comosition o t$e

comle9 4as o3tained ,sing t$e ollo4ing relations$is:

% Pertechnetate (99mTcO4-) & ! acti'ity at t$e sol'ent ront in t$e ITLC-SG / "aCl

system.

% Reduced-hydrolyzed Tc (99mTcO2-) & ! acti'ity remaining at t$e origin in t$e

#$atman "o. ; / 70! Acetonitril: 70! H system.

% *econdary com#le' & ! acti'ity at + f & 0 < 0.5 in t$e ITLC/12 system < !

red,ced $ydrolyed Tc.% Pr$mary com#le' & ! acti'ity at + f & 0.5 < ; in t$e ITLC/12 system < !

ertec$netate.






NM6

99mTc-H/P,O





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1

2





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2






NM7

99mTc-/,,

Procedure:Proer aer c$romatogra$y roced,re can 3e ,sed to searate mTc-AA rom ree

ertec$netate. +T-* stris are ,sed as stationary $ase and ,cetone (HP

rade) as sol'ent.

#$ere%

% 99mTc-Pertechnetate & ! acti'ity at t$e sol'ent ront (+ & ;.0)

%99m

Tc-/,, and % Reduced-hydrolyzed Tc (99m

TcO2-

) = (! acti'ity remaining att$e origin (+ & 0.0).






NM7

99mTc-/,,





1

2





1

2





1

2





1



2



Radiopharmaceutical QA ProgramNM8

99mTc-/a3

Procedure:T4o c$romatogra$ic systems are ,sed to dierentiate 3et4een t$e t$ree ersisting secies

*ytem +" +T-* &thyl ,cetate-/&5 (3"2)

*ytem ++" +T-* 60% ,ceton$tr$l

#$ere%


% Reduced-hydrolyzed Tc (99m

TcO2-

) & ! acti'ity remaining at t$e origin in System II% 99mTc-/,3 & (! acti'ity at t$e sol'ent ront in System II) - ! Pertec$netate ( mTc*-) or%

& (! acti'ity remaining at t$e origin in System I) - ! +ed,ced-$ydrolyed Tc (mTc-).

Results:

% 99mTc-/,3 = 100 (%99mTcO4- ! %99mTcO2-)






NM8

99mTc-/a3





1

2





1

2





1

2



Reult %RP PH ,##roal .y*ytem %Pur$ty %+m#ur$ty



1

2




NM9

99mTc-/DP

Procedure:System I: ITLC-SG / Acetone (HPLC grade)


#$ere%



II

% 99mTc-/DP & (! acti'ity at t$e sol'ent ront in System II) - ! Pertec$netate

(mTc*-) or%



Results:% 99mTc-/DP = 100 (%99mTcO4- ! %99mTcO2

-)






NM9

99mTc-/DPDate " Pre#arat$on t$me "




1

2





1

2





1

2





1

2






99mTc-/+.+

Procedure:An acc,rate aer c$romatogra$y roced,re introd,ced 3y Patel et al7 (1996) can 3e

alied to searate mTc-I6I rom ot$er im,rities. 8hatman 3// #a#er stris

are ,sed as stationary $ase and 9979% ethyl acetate as sol'ent.

#$ere%

% 99mTc-/+.+ & ! acti'ity at t$e sol'ent ront (+ & 0.77-0.=7)

% Pertechnetate (99mTcO4-) ! % Reduced-hydrolyzed Tc (99mTcO2-) = (! acti'ity

remaining at t$e origin (+ & 0.0-0.;).






99m

Tc-/+.+Date " Pre#arat$on t$me "




Samle ;

Samle





Samle ;

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99mTc-anocollo$d

Procedure:S,ita3le aer c$romatogra$y roced,re can 3e ,sed to searate mTc-"anocolloid

rom ree ertec$netate. 8hatman &T-31stris are ,sed as stationary $ase and

079% al as sol'ent.

#$ere%


%99m

Tc-anocollo$d and % Reduced-hydrolyzed Tc (99m

TcO2-

) = (! acti'ityremaining at t$e origin (+ & 0.0).






99m

Tc-anocollo$d





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2





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99mTc-Pertechnetate Procedure:An acc,rate aer c$romatogra$y roced,re can 3e alied to searate mTc-

Pertec$netate rom ot$er im,rities. +T-* stris are ,sed as stationary $ase and

/ethyl &thyl 5eton(/&5) as sol'ent.

#$ere%

% 99mTc-Pertechnetate & ! acti'ity at t$e sol'ent ront (+ & 0.-;.0)

% Reduced-hydrolyzed Tc (99mTcO2-) and other $m#ur$t$e = (! acti'ity remaining

at t$e origin (+ & 0.0-0.;).






99m

Tc-PertechnetateDate " Pre#arat$on t$me "




1

2





1

2





1

2





1

2






99mTc-Pyro#ho#hate

Procedure:System I: ITLC-SG / Acetone (HPLC grade)


#$ere%



II

% 99mTc- P:P & (! acti'ity at t$e sol'ent ront in System II) - ! Pertec$netate

(mTc*-) or%



Results:

% 99mTc- P:P = 100 (%99mTcO4- ! %99mTcO2-)






99mTc-Pyro#ho#hate

Date " Pre#arat$on t$me "$al lot no " &'#$re date:



1

2




1

2





1

2




1

2






99mTc-*ul;ur ollo$d

Procedure:Proer aer c$romatogra$y roced,re can 3e ,sed to searate mTc-SC rom ree

ertec$netate. +T-* stris are ,sed as stationary $ase and ,cetone (HP

rade) as sol'ent.

#$ere%


% 99mTc-* and % Reduced-hydrolyzed Tc (99mTcO2-) = (! acti'ity remaining at

t$e origin (+ & 0.0).






99mTc-*ul;ur ollo$dDate " Pre#arat$on t$me "




1

2





1

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2






NML-1

99mTc-Tetro;om$n (/yo$e<)

>ate : Prearation time :

?ial lot no : 19ire date:

Statonar! P"ase:

#$atman "o.;

#o$le P"ase:

1t$yl Acetate .!

Procedure:#$atman "0.;/ 1t$yl Acetate miniat,ried system can 3e ,sed s,ccess,lly to

searate t$e la3eled comle9 (mTc-Tetroosmin)% 4$ic$ migrates to t$e sol'ent ront

(+ & 0.*-0.@) rom t$e la3eling im,rities 4$ic$ remain at t$e origin (+ & 0.0- 0.;) .




99m

Tc-Tetro;om$n (/yo$e<)







Samle ;

Samle





Samle ;

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Samle

qc rp kits (mid kfsh d)

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