I-131 sodium iodide solutions, drug substances supported with Active Substance Master File
| Product name: |
I-131 sodium iodide sterile solution, drug substance according to European Pharmacopoeia 0281 monograph |
I-131 sodium iodide non-sterile solution, drug substance for radiolabelling according to European Pharmacopoeia 02121 monograph |
| Product code: |
I-RA-7 |
I-RA-5 |
| Description: | Clear, colourless and sterile solution of 131I sodium iodide containing iodine-131 in the form of sodium idoide in Na2CO3/NaHCO3/NaOH buffer and 0.5-2 mg/ml sodium thiosulphate solution, reducing agent diluted accoring to the cusomer specified active concentration. Bacterial endotoxins <100 IU/ml.
Non-carrier added |
Clear, colourless and non-sterile solution of 131I sodium iodide containing iodine-131 in the form of sodium iodide in Na2CO3/NaHCO3/NaOH buffer diluted with 0.0001M NaOH according to the customer specified active concentration.
Non-carrier added. No reducing agents added. |
| Volume: | 0.2 – 10.0 ml | 0.2 – 10.0 ml |
| Radioactive concentration: | 0.1 – 55.5 GBq/ml | ≥ 0.1-55.5 GBq/ml |
| Radionuclidic purity: | 131I ≥ 99.9 % | 131I ≥ 99.9 % |
| Radiochemical purity: | ≥ 95 % | ≥ 95 % |
| pH | 7 – 10 | 8 – 11 |
| Expiry time: | 21 days from manufacturing date | 21 days from manufacturing date |
| Other information: | Active pharmaceutical ingredient for manufacture of radiopharmaceuticals by dilution with water or by for capsule preparation.
For oral administration. |
Active ingredient for manufacture of radiopharmaceuticals by dilution – e.g. with water or buffer for labelling purposes or capsule preparation, for oral administration. |
| Storage: | Store at room temperature in its own container, in accordance with the regulations on radioactive materials. | Store at room temperature in its own container, in accordance with the regulations on radioactive materials. |
| Packaging: | In type I injection vial (6R or 10 R), closed with brombutyl stopper and green aluminium cap in lead container with paper insert (Type A packaging).
Pack size: ≤ 29.6 GBq (at the indicated calibration date)/vial |
In type I injection vial (6R or 10 R), closed with brombutyl stopper and green aluminium cap in lead container with paper insert (Type A packaging).
Pack size: ≤ 111 GBq (at the indicated calibration date)/vial |