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KIT FOR THE PREPARATION OF DIETHYLENE TRIAMINE PENTA ACETATE (Sn) Tc-99m INJECTION
Indication: Glomerular clearance measurement/cerebral angioscintigraphy.
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free
mixture of:
(DTPA) CaNa3diethylene triamine penta acetate
20.0 mg
Stannous chloride dehydrate
0.50 mg
Ascorbic acid
0.018 mg
After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one
obtains an injectable solution of 99mTc - (Sn)-DTPA with the following
characteristics:
Volume
2 - 5 ml
Max. Activity
300 mCi
Radiochemical purity
> 95.0 %
PH
5-6
Storage
Store the kit
2 - 8 c and protect from light
Store the reconstituted kit
15-25C
Preparation
Injection sterile 99mTc (up to 300 mCi) aseptically into the vial in a
volume of 2-5 ml
Dissolve the lyophilized material by shaking the vial for 10 seconds and
MDP Tck-pars-200
DMSA Tck-pars-500
Sn++ Tck-pars-600
KIT FOR THE PREPARATION OF (Sn) 99mTc Red Blood Cell (RBC) In-vitro labelling, for INJECTION
Indication: GI bleeding, blood pool imaging
Each package contains 3 lyophilized kits and 2 vials solution.
1- Each of 3 lyophilized vials contains, in vacuum sterile and pyrogen free
mixture of:
Sodium citrate dehydrate
3.70 mg
Stannous chloride dihydrate
0.105 mg
Anhydrous dextrose
5.5 mg
2- Each of two vials for three times labelling contains:
a.Brown color vial; sodium hypochlorite
2.3 ml
b.Colorless vial; ACD solution
3.6 ml
Storage
Store the kit and solutions
2-8 C
Store the reconstituted kit
15-25 C
Preparation (Labelling procedure In-vitro)
Take 0.1 ml of ACD solution by the syringe (19-21G needle).
Collect patients blood in 1-3 ml, mix gently.
Inject the patients blood to lyophilized vial (reaction vial), mix slowly
and wait for 5 min.
Inject 0.6 ml of sod. Hypochlorite (2-a) to the reaction vial, then mix gently.
Inject 1.0 ml of ACD solution (2-b) to the reaction vial and then mix gently.
Inject 10-100 mCi of sodium pertechnetate (99mTcO-4) in 1-3 ml to the
PYP Tck-pars-900
2-25C
15-25C
>1.0
< 1.0
Sterility Test
Preparation
Test for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as de99m
Inject sterile
Tc (up to 80 mCi) aseptically into the vial a volume of scribed in U.S. pharmacopeia.
2-6 ml
Pyrogen Test
Dissolve the lyophilized material by shaking the vial for 10 seconds.
LAL test and rabbit test on kits for 99mTc-Radiopharmaceuticals are carried out
Wait for 15 min.
as described in U.S. pharmacopeia.
Examine the radiochemical purity (RCP).
BRIDA Tck-pars-1000
KIT FOR THE PREPARATION OF TRIMETHYL- BROMO- IDA (Sn) 99mTc INJECTION
Indication: Visualization of the hepatobiliary system, examination of the
hepatobiliary function.
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
N-(2,4,6- trimethyl-3-bromoacetanilido iminodiacetic acid(Mebrofenin)25.0 mg
Stannous chloride dehydrate
0.20 mg
After adding a sterile and pyrogen free solution of pertechnetate 99mTc, one
obtains an inject able solution of 99mTc -(Sn)-Br-IDA with the following characteristics:
Volume
up to 5.0 ml
Max. Activity
50.0 mCi
Radiochemical purity
> 95.0 %
PH
5-6
Storage
Store the kit
2-8 C
Store the reconstituted injection
15-25 C
Preparation
Inject sterile 99mTc (up to 50 mCi) aseptically into the vial in a volume of 2-5 ml
Dissolve the lyophilized material by shaking the vial for 10 seconds.
Wait for 15 minutes.
Examine the radiochemical purity (RCP).
Preparation
Inject sterile 99mTc (up to 40 mCi) aseptically into the vial in a volume of 2.5 ml
Dissolve the lyophilized material by shaking the vial for 10 seconds
Wait for 15 min at the room temperature
MIBI Tck-pars-1200
Phytate Tck-pars-1400
Labelled preparation is to be use within 6 hrs. Within this period the total
RCP of 99mTc-phytate should be more than 95.0%.
Quality control of 99mTc-phytate
P.Chromatography No.1(Whatman) / Methanol-Acetone(1:1)
Rf 99mTc0-4=0.75-1.0
Biological Distribution of 99mTc-phytate in mice (n=3), Expressed in %dose/
Critical organ:
Lung
<5.0
Liver and spleen
>80.0
Stomach, Intestine
<1.0
Sterility Test
Test for sterility on kits for 99mTc-Radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen Test
LAL test and rabbit test on kits for 99mTc-Radiopharmaceuticals are carried
out as described in U.S. pharmacopeia.
EC Tck-pars-1600
1.0 mg
0.125 mg
After adding a sterile and pyrogen free solution of pertechnetate 99mTc, shake
the vial for 10 seconds.
Add 2 ml of phosphate buffer solution, shake for 10 seconds. Wait for 15 min.
99mTc (Sn)-EC has the following characteristics:
Volume
up to 5 ml
Activity
10-100 mCi
Radiochemical purity
> 95.0 %
PH
7.5-8.5
Stability of 99mTc-EC
4 hrs
Storage
Store the kit
2-8 C
Store the reconstituted kit
15-25 C
Preparation
Add aseptically sterile, non-pyrogenic 99mTc (10-150mCi) in app.1 to 3 ml.
Shake the contents of the vial for a few seconds.
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ECD Tck-pars-1700
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MAA Tck-pars-1800
KIT FOR THE PREPARATION OF AN INJECTABLE SUSPENSION OF HUMAN SERUM ALBUMIN MACROAGGRIGATES (Sn) 99mTc
Indication: lung scintigraphy.
Each vial contains, in vacuum, a lyophilized, sterile and pyrogen free mixture of:
Human serum albumin macroaggrigates
3.0 mg
Stannous chloride dehydrate
0.03 mg
Tween-80
0.057 mg
After adding a sterile and pyrogen free solution of pertechnetate Tc-99m, one
obtains an injectable solution of 99mTc - (Sn) - macroaggrigates with the following characteristics:
Volume
up to 5.0 ml
Activity
5 - 30.0 mCi
Radiochemical purity
> 95.0 %
PH
5.5 -6.5
Size of particles after labelling
10 - 90 m
Number of particles per vial
700000 - 1000000
Number of particles for injection (adult)
200000 - 300000
Storage
Store the kit
2 - 8 C
Store the reconstituted kit
15-25C
Preparation
Injection sterile 99mTc (5 - 40 mCi) aseptically into the vial in a volume of 2 - 5 ml.
Dissolve the lyophilized material by shaking the vial for 10 seconds and
12
Sulfurcolloid Tck-pars-1900
13
Rf 99mTcO2+99mTc- Sulfurcolloid
Rf 99mTcO-4
Radiochemical purity
0.0-0.20
0.20-1.0
> 95.0 %
Antimony TS
Tck-pars-2100
2-8 C
15-25 C
Preparation
Add 0.5 ml of hydrochloric acid solution (2-a) to the reaction vial (red
solution).
Add 10-100 mCi of freshly pertechnetate (99mTcO-4) in 1-3 ml to the reaction vial.
Heat 30 min in boiling water bath.
Cool, add 1.0 ml of phosphate buffer solution (2-b) to reaction vial.
The reconstituted solution is stable for 4 hrs.
14
0.0-0.20
0.20-1.0
> 95.0%
15
99mTc-radiopharmaceuticals
Pyrogen test:
LAL test and rabbit test on kits for
scribed in U.S. pharmacopeia.
99mTc-radiopharmaceuticals
Imaging protocols:
For scintigraphy, a bolus injection of 99mTc-Tyrosine-Octreotide, corresponding to activity in the range 555740 MBq added to 20 g of peptide, should be given. Whole-body
anterior and posterior images followed by SPECT views of the region of interest should
also be obtained at 90 min post injection. A high activity adsorption compared to background is considered as a positive result.
16
17
Quality control:
ITLC on silica gel 60 (Merck) using different mobile phases: 0.1 M sodium citrate (pH 5) to
determine the non-peptide bound 99mTc coligand and 99mTcO4- (Rf = 1), the mixture of
methanol/1 M ammonium acetate in a volume ratio of 1:1 for 99mTc colloid (Rf = 0). The
radioactivity was quantified by cutting the strip (1.5 10 cm2) into 1 cm pieces and counting
in a well type gamma counter. Percent of complex is equal to: 100 - (% non-peptide bound
99mTc coligand and 99mTcO4- + % 99mTc colloid) which should be over %90.
HPLC with C-18 reverse phase column (250/4.6) and 0.1% trifluoroacetic acid/water (Solvent A) and acetonitrile (Solvent B) as a mobile phase in the following gradient: 0 min 95%
A (5% B), 5 min 95% A (5% B), 20 min 0% A (100% B), 25 min 0% A (100% B), 30 min 95%
A (5% B), flow = 1 mL/min, Rt of complex ~ 14 min. Percent of complex should be over %90.
Sterility test:
Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as described in U.S.
pharmacopeia.
Pyrogen test:
LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as described
in U.S. pharmacopeia.
Imaging protocols:
For scintigraphy, a bolus injection of 99mTc-Ubiquicidine, corresponding to activity in the range
555740 MBq added to 40 g of peptide, should be given. Immediately after injection, dynamic
imaging should be acquired for the suspected infection area and the contralateral healthy
side as a non-target area. The dynamic study should be performed immediately after injection
with 60 s for each frame up to 30 min. Whole-body anterior and posterior images followed by
SPECT views of the region of interest should also be obtained at 30 min post injection. A high
and stable activity adsorption compared to background is considered as a positive result.
18
CIPROFLOXACIN
Tck-pars-2700
19
15 - 25 C
Quality control:
ITLC-SG using different mobile phases: Acetone for free 99mTcO4- (Rf = 1)
and ethanol: water: ammonium hydroxide (2: 5: 1 v/v) for 99mTc colloid (Rf =
0). The radioactivity was quantified by cutting the strip (1.5 10 cm2) into 1 cm
pieces and counting in a well type gamma counter. Percent of complex is equal
to: 100 - (% 99mTcO4- + % 99mTc colloid) which should be over %90.
Sterility test:
Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Pyrogen test:
LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out
as described in U.S. pharmacopeia.
Imaging protocols:
For scintigraphy, a bolus injection of 99mTc-Ciprofloxacin, corresponding to activity in the range 555740 MBq added to 2 mg of antibiotic, should be given. Immediately after injection, dynamic imaging should be acquired for the suspected infection area and the contralateral healthy side as a non-target area. The dynamic
study should be performed immediately after injection with 60 s for each frame up
to 30 min. Whole-body anterior and posterior images followed by SPECT views
of the region of interest should also be obtained at 60 min post injection. A high
and stable activity adsorption compared to background is considered as a positive
result.
TRODOT-1 Tck-pars-2800
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Preparation:
l Add 0.5 ml 0.9% saline in an evacuated vial, and allow the mixture to preincubate for 5 min.
l Add aseptically sterile and non-pyrogenic solution of 99mTcO4- (925-1,480 MBq)
in 0.5 mL saline.
l Shake the contents of the vial slowly for a few seconds.
l Incubate the vial for 30 minutes at 95 C.
l Wait 30 minutes for cooling to room temperature.
lThe reconstituted solution is stable for 6 hrs.
Quality control:
l HPLC with C-18 reverse phase column (250/4.6) and 0.1% trifluoroacetic acid/
water (Solvent A) and acetonitrile (Solvent B) as a mobile phase in the following gradient: 0 min 95% A (5% B), 5 min 95% A (5% B), 20 min 0% A (100% B), 25 min 0%
A (100% B), 30 min 95% A (5% B), flow = 1 mL/min, Rt of complex ~ 18 min. Percent
of complex should be over %90.
Sterility test:
Test for sterility on kits for 99mTc-radiopharmaceuticals are carried out as described
in U.S. pharmacopeia.
Pyrogen test:
LAL test and rabbit test on kits for 99mTc-radiopharmaceuticals are carried out as
described in U.S. pharmacopeia.
Imaging protocols:
l For scintigraphy, a bolus injection of 99mTc-TRODAT-1, corresponding to
activity in the range 814-1036 MBq should be given. SPECT views of the region of
interest should be obtained at 240 min post injection.