ECD PRODUCT SPECIFICATION L,L-Ethyl cysteinate dimer

Transcription

1 ECD PRODUCT SPECIFICATION Generic name : Chemical name : Bicisate 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 : SH HS O O N N O O 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

2 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.

3 2 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 ( 99m Tc O - 4 ) to form Technetium-99m -2,6 Diisopropylacetanilido Iminodiacetic acid ( 99m Tc-DISIDA ). The chemical structure of DISIDA : CH(CH 3 ) 2 O NH C CH 2 N CH 2 CH 2 O C C OH OH CH(CH 3 ) 2 O 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

4 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.

5 4 DMSA PRODUCT SPECIFICATION Generic name : Chemical name : Succimer 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 ( 99m TcO - 4 ) to form 99m Tc-(III)DMSA at ph and 99m Tc-(V)DMSA at ph as follows; 1) 99m Tc(III)-DMSA : DMSA is labeled with Technetium-99m ( 99m TcO - 4 ) to form Technetium-99m (III) -2,3 dimercaptosuccinic acid ( 99m Tc(III)-DMSA ). The labeled product must be incubated for 15 minutes before injection. 2) 99m Tc(V)-DMSA : DMSA is reconstituted with 1.0 ml of Bicarbonate buffer ph 9.0 and labeled with Technetium-99m ( 99m TcO - 4 ) to form Technetium-99m (V) -2,3 dimercaptosuccinic acid ( 99m Tc(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

6 5 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 99m Tc(V)-DMSA) ph : The ph of the reconstituted product is 1) 2.0 to 3.0 for 99m Tc(III)-DMSA and 2) 8.0 to 9.0 for 99m Tc(V)-DMSA Radiochemical purity : 1) For 99m Tc(III)-DMSA ; Not less than 85.0% of the total radioactivity is found as 99m Tc-dimercaptosuccinic acid 2) For 99m Tc(V)-DMSA ; Not less than 95.0% of the total radioactivity is found as 99m Tc-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 99m Tc(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

7 kidneys and sum of liver and spleen. Less than 1.0% of the administration dose per gram is found in the femur. 2) For 99m Tc(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) 6 Shelf life : Six hours after labeling for both 99m Tc(III)-DMSA and 99m Tc(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.

8 7 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 ( 99m Tc O - 4 ) to form Technetium -99m- Dimethylenetriamine pentaacetic acid ( 99m Tc-DTPA). The chemical structure of DTPA : COOH CH 2 N COOH CH 2 CH 2 CH 2 N CH 2 CH 2 N CH 2 CH 2 CH 2 COOH COOH COOH 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.

9 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 : 99m Tc-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

10 9 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 ( 99m TcO - 4 ) to form Technetium -99m- Macroaggregated albumin ( 99m Tc- 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.

11 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. 10 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.

12 11 MAG 3 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 (TcO - 4 ) to form Technetium-99m- Mercaptoacetyltriglycine ( 99m Tc-MAG 3 ). The chemical structure of mercaptoacetyltriglycine : O O NH HN SH HN O COOH 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

13 12 Radiochemical purity : Not less than 90.0% of the total radioactivity is found as 99m Tc-MAG 3 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.

14 One package contains five vials. 13

15 14 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(TcO - 4 ) to form Technetium -99m- Methylene Diphosphonate ( 99m Tc-MDP). The chemical structure of methylene diphosphonic acid : HO O H O P C P OH OH H OH 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

16 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.

17 16 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(TcO - 4 ) to form Technetium -99m- Methoxyisobutyl isonitrile ( 99m Tc-MIBI). The chemical structure of Methoxyisobutyl isonitrile : CH 3 CN CH 2 C OCH 3 CH 3 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 mg ph : The ph of the reconstituted product is 5.0 to 6.0.

18 17 Radiochemical purity : Not less than 90.0% of the total radioactivity is found as 99m Tc-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.

19 18 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 (TcO - 4 ) to form Technetium-99m- Phytate ( 99m Tc- Phytate). The chemical structure of Phytic acid : (OH) 2 OPO (OH) 2 OPO OPO(OH) 2 OPO(OH) 2 OPO(OH) 2 OPO(OH) 2 Composition : Each vial contains Sodium phytate 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.

20 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.

21 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 99m Tc at the time of administration. Sn(II) : The average amount of Stannous chloride must be at least 50% of the quoted value.

22 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 21 Storage : The product should be stored at 2-8 o C Packaging : 10 ml. vial sealed with a rubber stopper and aluminium cap. One package contains five vials.

23 22 Hynic-TOC PRODUCT SPECIFICATION Generic name : Chemical name : Hydrazinonicotinyl-Tyr 3 -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-Tyr 3 -Octreotide (Hynic-TOC) and EDDA phosphate buffer. It can be labeled with Technetium-99m(TcO - 4 ) to form Technetium -99m- Hynic-TOC. Composition : The kit is composed of three different components (one component/vial) Component A : Frozen solution (-30 o C) of EDDA 40 mg in 0.2 M Na 2 HPO 4 Component B : Lyophilized mixture of : Stannous chloride dihydrate 20 µg Tricine 20 mg D-Mannitol 20 mg Component C : Frozen solution (-30 o C) 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.

24 Sn(II) : The average amount of Stannnous chloride must be at least 50% of the quoted value. 23 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 o C 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