Technetium-99m L,L-Ethyl Cysteinate Dimer Injection

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05-Nov-12 Technetium-99m L,L-Ethyl Cysteinate Dimer Injection ( 99m Tc-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 99m Tc-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.

Transcript of Technetium-99m L,L-Ethyl Cysteinate Dimer Injection

Page 1: Technetium-99m L,L-Ethyl Cysteinate Dimer Injection

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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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

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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

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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

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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

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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

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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

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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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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

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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

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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