Radiopharmaceutical kit specification(99mTc-ECD)
Description : Technetium-99m L, L-Ethyl Cysteinate Dimer Injection is a sterile,
nonpyrogenic aqueous solution suitable for intravenous administration.
The chemical structure of 99mTc-L,L-Ethyl Cysteinate Dimer :
pH : Between 6.0 and 8.0.
Radiochemical purity : Not less than 90.0% of the total radioactivity is found as 99m
Tc-ECD at
the time of administration.
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.
Storage : At room temperature
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suitable for intravenous administration.
The chemical structure of 99mTc-DISIDA :
pH : Between 5.0 and 7.0
Radiochemcial purity : Not less than 90.0 % of the total radioactivity is found as 99m
Tc-DISIDA
CH(CH3)2
-CH2-C(O)-NH
CH(CH3)2
R =
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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/VUSP 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.
Storage : At room temperature
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pH : Between 2.0 and 3.0
Radiochemical purity : Not less than 85.0 % of the total radioactivity is found as 99mTc-
dimercaptosuccinic acid at the time of administration
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/VUSP Endotoxin Unit per
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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 : Six hours after labeling. .
Storage : The product can be stored at room temperature and protected from light
Packaging : Sterile syringe shielded within a lead pig
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pH : Between 8.0 – 9.0
Radiochemical purity : Not less than 95.0 %of the total radioactivity is found as 99mTc-
dimercaptosuccinic acid at the time of administration.
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
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which V is the maximum recommended total dose, in ml, at the
expiration date or time.
Shelf – life : Six hours after labeling.
Storage : The product should be stored at room temperature and protected from
light.
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nonpyrogenic aqueous solution suitable for intravenous administration.
The chemical structure of 99mTc-DTPA :
pH : Between 3.8 and 7.5.
Radiochemical purity : Not less than 90.0% of the total radioactivity is found as 99m
Tc-DTPA at
the time of administration.
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
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which V is the maximum recommended total dose, in ml, at the
expiration date or time.
Storage : At room temperature
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RC040 10 mCi
Generic name : Macrosalb
of controlled particle size of albumin aggregated suitable for intravenous
administration.
pH : Between 3.8 and 8.0
Particle size : 10-90 µm. Not more than 10 particles have a diameter 100 µm, and no particle
should exceed 150 µm
Radiochemical purity : Not less than 90.0 % of the total radioactivity is found as aggregated
albumin at the time of administration.
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.
Storage : At room temperature
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aqueous solution suitable for intravenous administration.
The chemical structure of 99mTc-mercaptoacetyltriglycine :
pH : Between 5.0 and 6.0
Radiochemical purity : Not less than 90.0% of the total radioactivity is found as 99m
Tc-MAG3 at
the time of administration.
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
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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.
Storage : At room temperature
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aqueous solution suitable for intravenous administration.
pH : Between 4.0 and 7.8
Radiochemical purity : Not less than 90.0 % of the total radioactivity is found as 99m
Tc-MDP at
the time of administration.
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.
Storage : At room temperature
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Aqueous solution suitable for intravenous injection.
The chemical structure of 99mTc-Methoxyisobutyl isonitrile :
pH : Between 5.0 and 6.0.
Radiochemical purity : Not less than 90.0% of the total radioactivity is found as 99mTc-MIBI
complex at the time of administration.
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
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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.
Storage : At room temperature
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RC045 30 mCi
solution suitable for intravenous administration.
pH : Between 5.0 and 8.0
Radiochemcial purity : Not less than 90.0% of the total radioactivity is found as 99m
Tc-
Phytate at the time of administration.
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.
Storage : At room temperature
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aqueous solution suitable for intravenous administration.
The chemical structure of 99mTc- Hynic-TOC :
pH : between 6.0 and 7.0
Radiochemical purity : Not less than 90.0% of the total radioactivity is found as 99m
Tc-
Hynic-TOC at the time of administration.
Sterility : Contamination of microorganism is not found in the product examined
in the condition of the test.
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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.
Storage : At room temperature
PRODUCT SPECIFICATION