Post on 21-Oct-2021
05-Nov-12
Technetium-99m L,L-Ethyl Cysteinate Dimer Injection
(99mTc-ECD)
PRODUCT SPECIFICATION
----------------------------
Product code number : RC037
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.
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Shelf – life : Six hours after labeling.
Storage : At room temperature
Packaging : Sterile syringe shielded within a lead pig
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2
Technetium-99m 2,6-Diisopropylacetanilido Iminodiacetic acid
Injection
(99m
Tc-DISIDA)
PRODUCT SPECIFICATION
-----------------------------
Product code number : RC038
Generic name : Disofenin
Description : Technetium-99m DISIDA Injection is a sterile, nonpyrogenic aqueous solution
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
at the time of administration.
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.
Shelf – life : Six hours after labeling.
Storage : At room temperature
Packaging : Sterile syringe shielded within a lead pig
22-Jun-12
4
Technetium-99m Dimercaptosuccinic acid Injection
(99m
Tc-(III)-DMSA).
PRODUCT SPECIFICATION
----------------------------
Product code number : RC043
Generic name : Succimer
Description : Technetium-99m-2,3-Dimercaptosuccinic Acid Injection is a sterile,
nonpyrogenic aqueous solution suitable for intravenous administration.
The chemical structure of 99mTc(III)-2,3 dimercaptosuccinic acid :
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
22-Jun-12
6
Technetium-99m Dimercaptosuccinic acid Injection
(99m
Tc-(V)-DMSA).
PRODUCT SPECIFICATION
----------------------------
Product code number : -
Generic name : Succimer
Description : Technetium-99m-2,3-Dimercaptosuccinic Acid Injection is a sterile,
nonpyrogenic, aqueous solution suitable for intravenous administration.
The chemical structure of 99mTc(V)-2,3 dimercaptosuccinic acid :
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.
Packaging : Sterile syringe shielded within a lead pig
22-Jun-12
8
Technetium-99m Dimethylenetriamine pentaacetic acid
(99m
Tc-DTPA)
PRODUCT SPECIFICATION
----------------------------
Product code number : RC043
Generic name : Pentetate
Description : Technetium-99m Dimethylenetriamine pentaacetic acid Injection is a sterile,
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.
Shelf – life : Six hours after labeling.
Storage : At room temperature
Packaging : Sterile syringe shielded within a lead pig
22-Jun-12
10
Technetium-99m Albumin Aggregated Injection
(99mTc-MAA)
PRODUCT SPECIFICATION
----------------------------
Product code number : RC039 5 mCi
RC040 10 mCi
Generic name : Macrosalb
Description : Technetium-99m Albumin Aggregated Injection is a sterile, aqueous suspension
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.
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Shelf – life : Six hours after labeling.
Storage : At room temperature
Packaging : Sterile syringe shielded within a lead pig
22-Jun-12
12
Technetium-99m Mercaptoacetyltriglycine Injection
(99mTc-MAG3)
PRODUCT SPECIFICATION
----------------------------
Product code number : RC036
Generic name : Mertiatide
Description : Technetium-99m Mercaptoacetyltriglycine Injection is a sterile, nonpyrogenic,
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.
Shelf – life : Six hours after labeling.
Storage : At room temperature
Packaging : Sterile syringe shielded within a lead pig
22-Jun-12
14
Technetium-99m Methylene Diphosphonate Injection
(99m
Tc-MDP)
PRODUCT SPECIFICATION
----------------------------
Product code number : RC033
Generic name : Medronate
Description : Technetium-99m Methylene Diphosphonate Injection is a sterile, nonpyrogenic,
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.
Shelf – life : Six hours after labeling.
Storage : At room temperature
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Packaging : Sterile syringe shielded within a lead pig
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16
99mTc-Methoxyisobutyl Isonitrile Injection
(99mTc-MIBI)
PRODUCT SPECIFICATION
------------------------------
Product code number : RC031
Generic name : Sestamibi
Description : Technetium-99m Methoxyisobutylisonitrile Injection is a sterile
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.
Shelf – life : Six hours after labeling.
Storage : At room temperature
Packaging : Sterile syringe shielded within a lead pig
22-Jun-12
18
Technetium-99m Phytate Injection
(99m
Tc-Phytate )
PRODUCT SPECIFICATION
-----------------------------
Product code number : RC044 5 mCi
RC045 30 mCi
Description : Technetium-99m Phytate Injection is a sterile, nonpyrogenic, aqueous
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.
Shelf – life : Six hours after labeling.
Storage : At room temperature
Packaging : Sterile syringe shielded within a lead pig
22-Jun-12
19
Technetium-99m Hydrazinonicotinyl Tyr3-Octreotide Injection
( 99mTc-Hynic-TOC)
PRODUCT SPECIFICATION
-----------------------------
Product code number : RC025
Generic name : -
Description : Technetium-99m Hynic-TOC Injection is a sterile, nonpyrogenic
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.
Shelf- life : Four hours after labeling
Storage : At room temperature
Packaging : Sterile syringe shielded within a lead pig