Bicisate QC

Bicisate (Neurolite) Quality Control Procedure

Materials needed:

Bakerflex silica gel IB-F TLC plate
Ethyl Acetate
Scissors
Pencil/Pen
Counting tubes/vials
MCA or SCA or Scaler with scintillation well

Procedure:

1. See General QC Procedure.

2. Spot sample 2 cm from the end of plate.

3. Develop immediately in ethyl acetate, allowing the solvent to migrate to the ink spot/line at top of the plate. This takes about 15 minutes.

4. Remove plate from solvent.

5. Cut plate 4.5 cm from the bottom.

6. Count each section of the plate.

Counts:

Top: Lipophilic tagged radiopharmaceutical
Bottom: Free Tc-99m, hydrolyzed reduced Tc-99m

% lipophilic tagged Tc-99m = (top counts)/(bottom counts + top counts) x 100

Neuro

USP Minimum Acceptable Purities:

Bicisate 90%