MAA Quality Control Procedure

I. See Procedure II for ITLC purity testing.

II. Particulate Inspection

Prepared kits of particulate Tc-99m radiopharmaceuticals must be checked for particle size and aggregation. Appropriate particle size permits the desired biodistribution during human administration while minimizing the patient risk.

Equipment:

Microscope
Hemocytometer (50 micrometers per grid square)
Cover Slides

Procedure:

1. Gently aggitate the kit vial and withdraw a sample.

2. Place a small drop of sample on the hemocytometer grid. Place a cover slide over the sample.

3. Place the hemocytometer under the microscope, focus on the appropriate power resolution and observe particles.

4. To meet USP standards, a minimum of 90% of all lung imaging particles should be from 10 to 90 micrometers in diameter. No particles should be greater than 150 micrometers.

5. Record results. Any kits found to have particles or clumps exceeding 150 micrometers shall be withheld from distribution.