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Chromium

Chromium [51Cr] Edetate Injection BP

Product Information (PI)

Consumer Marketing Information (CMI)

Product Code

10038

Indications

Chromium [51Cr] Edetate Injection BP is indicated for the determination of glomerular filtration rate in the assessment of renal function.

Appearance

Clear, violet solution contained in a 3mL (nominal) serum vial sealed with a gold cap.  The volume is as follows:  Material No. 10038: 1mL

Radioactive Concentration

7.2 to 8.8 MBq/mL at time and date of calibration

Radioactive Content 

7.2 to 8.8 MBq in 1 mL at Calibration

PH

The pH of the solution is between 3.5 - 6.5

Chromium Content 

≤1.0 mg/mL 

EDTA Content 

≤15mg/mL free EDTA

Radionuclidic Purity 

Only [51Cr] detected.  No detectable y emitting impurities

Radiochemical Purity

≥95% chromium [51Cr] edetate.  ≤0.5% uncomplexed chromium-51

Specific Activity

Adjusted to be ~ 30 GBq Chromium-51 per g Chromium

Sterility

Sterile

Pyrogens

≤175 Eu/mL

Calibration

0900 hours Sydney time on the first day of each calender month

Storage 

Ambient 

Availability

Ex stock

Expiry

31 days from calibration

Aust R

22779