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