MAG-3 QC

Mertiatide (MAG-3) Quality Control Procedure

Materials needed:

*Sep-Pak cartridge
200 proof Ethanol
1:1 Ethanol:0.9% Saline solution
0.001 N HCl
3 Counting vials with screw top lids
MCA or SCA or Scaler with scintillation well

*Alternative QC procedures exist, but this procedure has proven to be more reliable. Use of other solvents and medium must be validated before routine use.

Procedure:

1. SeeĀ General QC Procedure.

2. Prepare Sep-Pak:

a. Push 10 ml of 200 proof ethanol through the cartridge. Discard eluate.
b. Push 10 ml of 0.001 N HCl through the cartridge. Discard the eluate.
c. Dry cartridge by pushing 5 ml of air through the cartridge.

3. Analyze Sample:

a. Place 0.1 ml of sample in the long end of the cartridge.
b. Slowly push 10 ml of 0.001 N HCl through the cartridge. Collect in counting vial.
c. Slowly (dropwise) push 10 ml of 1:1 ethanol:0.9% saline through the cartridge. Collect in counting vial.
d. Place Sep-Pak in the third counting vial.

4. Assay each vial in the dose calibrator or well counter.

Counts:

0.001 N HCl: contains free Tc-99m sodium pertechnetate and some hydrolyzed reduced.

1:1 solution: contains the tagged mertiatide

Cartridge: contains hydrolyzed reduced Tc-99m plus other non-elutable impurities

% free Tc-99m = (counts of HCl)/(sum of all three fractions counts) x 100

% tagged mertiatide = (counts 1:1 solution)/(sum of all three fraction counts) x 100

 

USP Minimum Acceptable Purities:

MAG-3 90%