Radiopharmaceutical kit specificationisotope.tint.or.th/bdu/spec/ColdKitspec170556.pdf · 2013. 5....
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ECD PRODUCT SPECIFICATION ---------------------------- Generic name : Bicisate Chemical name : L,L-Ethyl cysteinate dimer Product code number : RC035 Description : L,L-Ethyl cysteinate dimer kit is a sterile, nonpyrogenic, lyophilized mixture of L,L-Ethyl cysteinate dimer and stannous chloride as reducing agent under nitrogen atmosphere. It can be labeled with Technetium-99m ( 99m TcO 4 - ) to form Technetium-99m L,L-Ethyl cysteinate dimer molecule ( 99m Tc-L,L ECD). The chemical structure of L,L-Ethyl Cysteinate Dimer : Composition : The kit is composed of two different components (one component/vial) ; Component A : L, L–ethyl cysteinatedimer 1.0 mg Stannous chloride dihydrate 0.08 mg D-mannitol 20.0 mg Na 2 -EDTA 0.3 mg Component B : 1 ml of 0.02 M Phosphate buffer, pH 7.5-8.0 N N SH HS O O O O
Transcript of Radiopharmaceutical kit specificationisotope.tint.or.th/bdu/spec/ColdKitspec170556.pdf · 2013. 5....
ECD
PRODUCT SPECIFICATION
----------------------------
Generic name : Bicisate
Chemical name : L,L-Ethyl cysteinate dimer
Product code number : RC035
Description : L,L-Ethyl cysteinate dimer kit is a sterile, nonpyrogenic, lyophilized mixture of
L,L-Ethyl cysteinate dimer and stannous chloride as reducing agent under
nitrogen atmosphere. It can be labeled with Technetium-99m (99mTcO4- ) to
form Technetium-99m L,L-Ethyl cysteinate dimer molecule
(99mTc-L,L ECD).
The chemical structure of L,L-Ethyl Cysteinate Dimer :
Composition : The kit is composed of two different components (one component/vial) ;
Component A : L, L–ethyl cysteinatedimer 1.0 mg
Stannous chloride dihydrate 0.08 mg
D-mannitol 20.0 mg
Na2-EDTA 0.3 mg
Component B : 1 ml of 0.02 M Phosphate buffer, pH 7.5-8.0
N N
SH HS
O O
O O
1
pH : The pH of the reconstituted product is 6.0 to 8.0.
Radiochemical purity : Not less than 90.0% of the total radioactivity is found as 99m
Tc-ECD at
the time of administration.
Sn(II) : The average amount of Stannous chloride must be at least 50% of the
quoted value.
Sterility : Contamination of microorganism is not found in the product examined
in the condition of the test.
Bacterial endotoxins : It meets the requirements of the Bacterial Endotoxin Test, the limit of
endotoxin content being not more than 175/V USP Endotoxin Unit per
ml of the injection, when compared with the USP Endotoxin RS, in
which V is the maximum recommended total dose, in ml, at the
expiration date or time.
*Biological distribution: Not less than 1.07 % of the radioactivity of the injected dose is
found in the brain at 5 min after injection.
(* = perform when a new batch of active ingredient is used)
Shelf – life : Six hours after labeling.
Expiry : One year after manufacturing.
Storage : The product should be stored at 2 - 8 °C.
Packaging : 10 ml vial sealed with a rubber stopper and aluminium cap.
One package contains five vials.
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DISIDA
PRODUCT SPECIFICATION
-----------------------------
Generic name : Disofenin
Chemical name : 2,6-diisopropylacetanilido iminodiacetic acid
Product code number : RC017
Description : DISIDA kit is a sterile, nonpyrogenic, lyophilized mixture of 2,6-
diisopropylacetanilido iminodiacetic acid and stannous chloride as reducing
agent under nitrogen atmosphere. It can be labeled with Technetium-99m
(99mTc O4- ) to form Technetium-99m -2,6 Diisopropylacetanilido Iminodiacetic
acid (99mTc-DISIDA ).
The chemical structure of DISIDA :
Composition : Each vial contains
DISIDA 10.0 mg
Stannous chloride dihydrate 0.1 mg
pH : The pH of the reconstituted product is 5.0 to 7.0
CH(CH3)2
NH C CH2
O
NCH2
CH2C
C
O
O
OH
OHCH(CH3)2
3
Radiochemcial purity : Not less than 90.0 % of the total radioactivity is found as 99m
Tc-DISIDA
at the time of administration.
Sn(II) : The average amount of Stannous chloride must be at least 50% of the
quoted value.
Sterility : Contamination of microorganism is not found in the product examined
in the condition of the test.
Bacterial endotoxins : It meets the requirements of the Bacterial Endotoxin Test, the limit of
endotoxin Composition being not more than 175/V USP Endotoxin Unit
per ml of the injection, when compared with the USP Endotoxin RS, in
which V is the maximum recommended total dose, in ml, at the
expiration date or time.
*Biological distribution : Not less than 70.0% of the injected radioactivity is presented in
gall bladder and intestines, not more than 10.0% of the injected
radioactivity is presented in the liver, not more than 10.0% in
the kidneys, not more than 3.0% of the injected radioactivity is
present in the stomach and not more than 3.0% of the injected
radioactivity is presented in the blood.
(* = perform when a new batch of active ingredient is used)
Shelf – life : Six hours after labeling.
Expiry : One year after manufacturing.
Storage : The product should be stored at 2-8 oC.
Packaging : 10 ml. vial sealed with a rubber stopper and aluminium cap.
One package contains five vials.
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DMSA
PRODUCT SPECIFICATION
----------------------------
Generic name : Succimer
Chemical name : 2,3 dimercaptosuccinic acid
Product code number : RC018 DMSA
RC022 DMSA(V)
Description : DMSA kit is a sterile, nonpyrogenic, lyophilized mixture of 2,3
dimercaptosuccinic acid and stannous chloride as reducing agent at under
nitrogen atmosphere. It can be labeled with Technetium-99m (99mTcO4- ) to
form 99mTc-(III)DMSA at pH 2.0-3.0 and 99mTc-(V)DMSA at pH 8.0-9.0 as
follows;
1) 99mTc(III)-DMSA : DMSA is labeled with Technetium-99m (99mTcO4- ) to form
Technetium-99m (III) -2,3 dimercaptosuccinic acid (99mTc(III)-DMSA ). The labeled product
must be incubated for 15 minutes before injection.
2) 99mTc(V)-DMSA : DMSA is reconstituted with 1.0 ml of Bicarbonate buffer pH 9.0 and labeled
with Technetium-99m (99mTcO4- ) to form Technetium-99m (V) -2,3 dimercaptosuccinic acid
(99mTc(V)-DMSA ). The labeled product must be incubated for 20 minutes before injection.
The chemical structure of 2,3 dimercaptosuccinic acid :
COOH CH CH COOH
SH SH
Composition : Each vial contains
Dimercaptosuccinic acid 1.0 mg
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Inositol 50.0 mg
Ascorbic acid 0.7 mg
Stannous chloride dihydrate 0.3 mg
Bicarbonate buffer: 7% Bicarbonate buffer pH 9.0 (served as component B for formulation of
99mTc(V)-DMSA)
pH : The pH of the reconstituted product is
1) 2.0 to 3.0 for 99mTc(III)-DMSA and
2) 8.0 to 9.0 for 99mTc(V)-DMSA
Radiochemical purity : 1) For 99mTc(III)-DMSA ; Not less than 85.0% of the total
radioactivity is found as 99mTc-dimercaptosuccinic acid
2) For 99mTc(V)-DMSA ; Not less than 95.0% of the total
radioactivity is found as 99mTc-dimercaptosuccinic acid
Sn(II) : The average amount of Stannous chloride must be at least 50% of the
quoted value.
Sterility : Contamination of microorganism is not found in the product examined
in the condition of the test.
Bacterial endotoxins : It meets the requirements of the Bacterial Endotoxin Test, the limit of
endotoxin Composition being not more than 175/V USP Endotoxin Unit
per ml of the injection, when compared with the USP Endotoxin RS, in
which V is the maximum recommended total dose, in ml, at the
expiration date or time.
*Biological distribution : 1) For 99mTc(III)-DMSA ; Not less than 40.0 % of the administered
radioactive dose is found in the kidneys and not less than 6:1 of
the administered radioactive dose is found in the ratio between
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kidneys and sum of liver and spleen. Less than 1.0% of the
administration dose per gram is found in the femur.
2) For 99mTc(V)-DMSA ; Not more than 10.0 % and 2.0% of the
administered radioactive dose is found in the kidneys and in
the liver respectively and not less than 1.5% I.D./g is found in
the femur.
(* = perform when a new batch of active ingredient is used)
Shelf – life : Six hours after labeling for both 99mTc(III)-DMSA and 99mTc(V)-DMSA
Expiry : Six months after manufacturing.
Storage : The product should be stored at 2-8 oC and protected from light
Packaging : 10 ml. vial sealed with a rubber stopper and aluminium cap.
One package contains five vials.
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DTPA
PRODUCT SPECIFICATION
----------------------------
Generic name : Pentetate
Chemical name : dimethylenetriamine pentaacetic acid
Product code number : RC019
Description : Dimethylenetriamine pentaacetic acid kit is a sterile, nonpyrogenic lyophilized
mixture of dimethylenetriamine pentaacetic acid and stannous chloride as a
reducing agent under nitrogen atmosphere. It can be labeled with Technetium-
99m (99mTc O4- ) to form Technetium -99m- Dimethylenetriamine pentaacetic
acid (99mTc-DTPA).
The chemical structure of DTPA :
Composition : Each vial contains
Dimethylenetriamine pentaacetic acid 5.0 mg
Calcium chloride 1.4 mg
Stannous chloride dihydrate 0.6 mg
pH : The pH of the reconstituted product is 3.8 to 7.5.
COOH CH2
N
CH2COOH
CH2 CH2N CH2 CH2 N
CH2
CH2
COOH
COOHCH2
COOH
8
Radiochemical purity : Not less than 90.0% of the total radioactivity is found as 99m
Tc-DTPA at
the time of administration.
Sn(II) : The average amount of Stannous chloride must be at least 50% of the
quoted value.
Sterility : Contamination of microorganism is not found in the product examined
in the condition of the test.
Bacterial endotoxins : It meets the requirements of the Bacterial Endotoxin Test, the limit of
endotoxin Composition being not more than 175/V USP Endotoxin Unit
per ml of the injection, when compared with the USP Endotoxin RS, in
which V is the maximum recommended total dose, in ml, at the
expiration date or time.
*Biological distribution : 99mTc-DTPA should be formulated within 1hr of kidney studies.
It is not bound with any kinds of tissue and excreted rapidly
and quantitatively in the urine. Not greater than 5.0% of the
injected radioactivity is retained in the kidney about 24 hr after
administration. Not less than 90% of the radioactivity is
excreted in urine within 90 min. after administration.
(* = perform when a new batch of active ingredient is used)
Shelf – life : Six hours after labeling.
Expiry : One year after manufacturing.
Storage : The product should be stored at 2-8 oC.
Packaging : 10 ml. vial sealed with a rubber stopper and aluminium cap.
One package contains five via
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MAA
PRODUCT SPECIFICATION
----------------------------
Generic name : Macrosalb
Chemical name : Macroaggregated Albumin
Product code number : RC014
Description : Macroaggregated albumin kit is a sterile, nonpyrogenic, lyophilized reagent
containing denatured human serum albumin (HSA) and stannous chloride as
reducing agent under nitrogen atmosphere. It can be labeled with Technetium-
99m (99mTcO4- ) to form Technetium -99m- Macroaggregated albumin (99mTc-
MAA).
Composition : Each vial contains
Human serum albumin 2.5 mg
Stannous chloride anhydrous 0.20 mg
pH : The pH of the reconstituted product is 3.8 to 8.0
Particle size : Not less than 90% of the observed aggregated particles have a diameter between
10 and 90 µm, and none of the observed particles have a diameter greater than
150 µm
Radiochemical purity : Not less than 90.0 % of the total radioactivity is found as aggregated
albumin at the time of administration.
10
Sn(II) : The average amount of Stannous chloride must be at least 50% of the
quoted value.
Sterility : Contamination of microorganism is not found in the product examined
in the condition of the test.
Bacterial endotoxins : It meets the requirements of the Bacterial Endotoxin Test, The limit of
endotoxin Composition being not more than 175/V USP Endotoxin Unit
per ml of the injection, when compared with the USP Endotoxin RS, in
which v is the maximum recommended total dose, in ml, at the
expiration date or time.
*Biological distribution : Not less than 80.0% of the radioactivity is found in lungs and
not more than 5.0% of the radioactivity is found in the liver and
spleen.
(* = perform when a new batch of active ingredient is used)
Shelf – life : Six hours after labeling.
Expiry : Five months after manufacturing.
Storage : The product should be stored at 2-8 oC.
Packaging : 10 ml. vial sealed with a rubber stopper and aluminium cap.
One package contains five vials.
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MAG3
PRODUCT SPECIFICATION
----------------------------
Generic name : Mertiatide
Chemical name : mercaptoacetyltriglycine
Product code number : RC015
Description : Mercaptoacetyltriglycine kit is a sterile, nonpyrogenic lyophilized mixture of
mercaptoacetyltriglycine, potassium gluconate, lactose and stannous
chloride as a reducing agent under nitrogen atmosphere. It can be labeled with
Technetium-99m (TcO4-) to form Technetium-99m- Mercaptoacetyltriglycine
(99mTc-MAG3).
The chemical structure of mercaptoacetyltriglycine :
Composition : Each vial contains
Mercaptoacetyltriglycine 1.0 mg
Stannous chloride anhydrous 63.0 µg
Potassium gluconate 22.0 mg
Lactose 20.0 mg
pH : The pH of the reconstituted product is 5.0 to 6.0
NH HN
O
O
OSH HN
COOH
12
Radiochemical purity : Not less than 90.0% of the total radioactivity is found as 99m
Tc-MAG3 at
the time of administration.
Sn(II) : The average amount of Stannous chloride must be at least 50% of the
quoted value.
Sterility : Contamination of microorganism is not found in the product examined
in the condition of the test.
Bacterial endotoxins : It meets the requirements of the Bacterial Endotoxin Test, the limit of
endotoxin Composition being not more than 175/V USP Endotoxin Unit
per ml of the injection, when compared with the USP Endotoxin RS, in
which V is the maximum recommended total dose, in ml, at the
expiration date or time.
*Biological distribution : Not more than 2.0% of the administered dose is found in the
kidney, not less than 80% of the administered dose is found in
the bladder and urine and less than 2 % of the administered
dose is found in the liver. It is rapidly excreted into urine
within 30 mins.
(* = perform when a new batch of active ingredient is used)
Shelf – life : Six hours after labeling.
Expiry : Nine months after manufacturing.
Storage : The product should be stored at 2-8 oC.
Packaging : 10 ml. vial sealed with a rubber stopper and aluminium cap.
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One package contains five vials.
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MDP
PRODUCT SPECIFICATION
----------------------------
Generic name : Medronate
Chemical name : Methylene Diphosphonate
Product code number : RC016
Description : Methylene Diphosphonate kit is a sterile, nonpyrogenic lyophilized mixture of
methylene diphosphonate and stannous chloride as a reducing agent under
nitrogen atmosphere. It can be labeled with Technetium-99m(TcO4-)
to form Technetium -99m- Methylene Diphosphonate (99mTc-MDP).
The chemical structure of methylene diphosphonic acid :
Composition : Each vial contains
Methylene Diphosphonic acid 10.0 mg
Stannous chloride anhydrous 1.2 mg
Sodium chloride 4.5 mg
pH : The pH of the reconstituted product is 4.0 to 7.8
P C PHO OH
HO O
OH OHH
15
Radiochemical purity : Not less than 90.0 % of the total radioactivity is found as 99m
Tc-MDP at
the time of administration.
Sn(II) : The average amount of Stannous chloride must be at least 50% of the
quoted value.
Sterility : Contamination of microorganism is not found in the product examined
in the condition of the test.
Bacterial endotoxins : It meets the requirements of the Bacterial Endotoxin Test, limit of
endotoxin Composition being not more than 175/V USP Endotoxin Unit
per ml of the injection, when compared with the USP Endotoxin RS, in
which V is the maximum recommended total dose, in ml, at the
expiration date or time.
*Biological distribution : Not less than 1.5% of the injected dose is found in the femur, not more
than 1.0% of the injected dose is found in the liver and not more than
0.05% of the injected dose per gram is found in blood.
(* = perform when a new batch of active ingredient is used)
Shelf – life : Six hours after labeling.
Expiry : One year after manufacturing.
Storage : The product should be stored at 2-8 oC.
Packaging : 10 ml vial sealed with a rubber stopper and aluminium cap.
One package contains five vials.
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MIBI
PRODUCT SPECIFICATION
------------------------------
Generic name : Sestamibi
Chemical name : Methoxyisobutyl isonitrile
Product code number : RC026
Description : Methoxyisobutyl isonitrile kit is a sterile, nonpyrogenic, lyophilized mixture of
tetra(2-methoxyisobutyl isocyano) Copper(I) tetrafluoroborate and stannous
chloride as a reducing agent under nitrogen atmosphere. It can be labeled with
Technetium-99m(TcO4-) to form Technetium -99m- Methoxyisobutyl isonitrile
(99mTc-MIBI).
The chemical structure of Methoxyisobutyl isonitrile :
Composition : Each vial contains:
Tetra(2-methoxyisobutyl isocyano)
Copper(I)tetrafluoroborate 1.0 mg
Sodium Citrate dihydrate 2.6 mg
L-Cysteine Hydrochloride monohydrate 1.0 mg
D-Mannitol 20.0 mg
Stannous chloride dihydrate 0.075 mg
pH : The pH of the reconstituted product is 5.0 to 6.0.
CN CH2 C OCH3
CH3
CH3
17
Radiochemical purity : Not less than 90.0% of the total radioactivity is found as 99mTc-MIBI
complex at the time of administration.
Sn(II) : The average amount of Stannous chloride must be at least 50% of the
quoted value.
Sterility : Contamination of microorganism is not found in the product examined
in the condition of the test.
Bacterial endotoxins : It meets the requirements of the Bacterial Endotoxin Test, the limit of
endotoxin Composition being not more than 175/V USP Endotoxin Unit
per ml of the injection, when compared with the USP Endotoxin RS, in
which V is the maximum recommended total dose, in ml, at the
expiration rate or time.
*Biological distribution : Approximately 1-2% of the administered radioactive dose is
found in the heart within 5 min. It is excreted by intestinal
pathway within 3 hrs.
(* = perform when a new batch of active ingredient is used)
Shelf – life : Six hours after labeling.
Expiry : Seven months after manufacturing.
Storage : The product should be stored at 2-8 °C.
Packaging : 10 ml. vial sealed with a rubber stopper and aluminium cap.
One package contains five vials.
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Phytate
PRODUCT SPECIFICATION
-----------------------------
Generic name : -
Chemical name : -
Product code number : RC020
Description : Phytate kit is a sterile, nonpyrogenic, lyophilized mixture of sodium phytate
and stannous chloride as a reducing agent under nitrogen atmosphere. It can be
labeled with Technetium-99m (TcO4-) to form Technetium-99m- Phytate
(99mTc- Phytate).
The chemical structure of Phytic acid :
Composition : Each vial contains
Sodium phytate 25.00 mg
Stannous chloride dihydrate 1.00 mg
pH : The pH of the reconstituted product is 5.0 to 8.0
Radiochemical purity : Not less than 90.0% of the total radioactivity is found as
99m
Tc-Phytate at the time of administration.
OPO(OH)2OPO(OH)2
OPO(OH)2
OPO(OH)2
(OH)2OPO
(OH)2OPO
19
Sn(II) : The average amount of Stannous chloride must be at least 50% of the
quoted value.
Sterility : Contamination of microorganism is not found in the product examined
in the condition of the test.
Bacterial endotoxins : It meets the requirements of the Bacterial Endotoxin Test, the limit of
endotoxin Composition being not more than 175/V USP Endotoxin Unit
per ml of the injection, when compared with the USP Endotoxin RS, in
which V is the maximum recommended total dose, in ml, at the
expiration date or time.
*Biological distribution : Not less than 80.0% of the radioactivity is found in the liver and not
more than 5.0% of the radioactivity is found in the kidneys and not
more than 5% of the radioactivity is found in the lungs.
(* = perform when a new batch of active ingredient is used)
Shelf – life : Six hours after labeling.
Expiry : One year after manufacturing.
Storage : The product should be stored at 2 - 8oC.
Packaging : 10 ml vial sealed with a rubber stopper and aluminium cap.
One package contains five vials.
20
Stannous
(Technetium agent for in vivo RBC labeling )
PRODUCT SPECIFICATION
-----------------------------
Generic name : -
Chemical name : -
Product code number : RC021
Description : Stannous kit is a sterile nonpyrogenic, lyophilized mixture of stannous
chloride and methylene diphosphonate under nitrogen atmosphere.
Reconstituted kit with 3 ml. of sterile isotonic saline provides a solution for
in vivo loading of Red Blood Cells with stannous ion preparatory to
Technetium -99m labeling.
Composition : Each vial contains
Stannous chloride dihydrate 1.80 mg
MDP 1.90 mg
pH : The pH of the reconstituted product is 5.5 to 8.0
Radiochemical purity : Not less than 90.0% of the RBC labeling efficiency of 99mTc at the time
of administration.
Sn(II) : The average amount of Stannous chloride must be at least 50% of the
quoted value.
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Sterility : Contamination of microorganism is not found in the product examined
in the condition of the test.
Bacterial endotoxins : It meets the requirements of the Bacterial Endotoxin Test, the limit of
endotoxin Composition being not more than 175/V USP Endotoxin Unit
per ml of the injection, when compared with the USP Endotoxin RS, in
which V is the maximum recommended total dose, in ml, at the
expiration date or time.
*Biological distribution : Not less than 60% of the injected dose is found in the blood, not
more than 4% of the injected dose is found in bone and the ratio
between blood to stomach is not less than 10.
(* = perform when a new batch of active ingredient is used)
Expiry : One year after manufacturing
Storage : The product should be stored at 2-8 oC
Packaging : 10 ml. vial sealed with a rubber stopper and aluminium cap.
One package contains five vials.
22
Hynic-TOC
PRODUCT SPECIFICATION
-----------------------------
Generic name : -
Chemical name : Hydrazinonicotinyl-Tyr3-Octreotide
Product code number : RC030
Description : Hynic-TOC kit is a sterile, nonpyrogenic lyophilized powder of stannous
chloride as reducing agent under nitrogen atmosphere and sterile, nonpyrogenic
solution of Hydrazinonicotinyl-Tyr3-Octreotide (Hynic-TOC) and EDDA
phosphate buffer. It can be labeled with Technetium-99m(TcO4-) to form
Technetium -99m- Hynic-TOC.
Composition : The kit is composed of three different components (one component/vial)
Component A : Frozen solution (-30oC) of EDDA 40 mg in 0.2 M Na2HPO4
Component B : Lyophilized mixture of :
Stannous chloride dihydrate 20 µg
Tricine 20 mg
D-Mannitol 20 mg
Component C : Frozen solution (-30oC) of Hynic-TOC 20 µg
pH : The pH of the reconstituted product is 6.0 to 7.0
Labeling efficiency : Not less than 85.0% of the total radioactivity is found as 99m
Tc-
Hynic-TOC before purification.
Radiochemical purity : Not less than 90.0% of the total radioactivity is found as 99m
Tc-
Hynic-TOC at the time of administration.
23
Sn(II) : The average amount of Stannnous chloride must be at least 50% of the
quoted value.
Sterility : Contamination of microorganism is not found in the product examined
in the condition of the test.
Bacterial endotoxins : It meets the requirements of the Bacterial Endotoxin Test, the limit of
endotoxin Composition being not more than 175/V USP Endotoxin Unit
per ml of the injection, when compared with the USP Endotoxin RS, in
which V is the maximum recommended total dose, in ml, at the
expiration date or time.
Shelf- life : Four hours after labeling
Expiry : Six months after manufacturing
Storage : The product should be stored at -30 oC or in freezer
Packaging : 10 ml vial sealed with a rubber stopper and aluminium cap for
component A and B, Eppendorff vial for component C
One package contains one or two kits
