Transdermal Testing

Transdermal Testing

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OEM
VOLUME



MATERIAL

Extraction cell ø32mm/8.03cm2 cover and ø38mm/2.94m; reservoir

PSEXCELL-38
Extraction cell ø32mm/8.03cm2 cover and ø38mm/2.94m; reservoir


Product number     PSEXCELL-38
OEM reference     22252, 09645
OEM     Universal
Material     316SS
Volume     2.94ml

  • According to EP 2.9.4.
  • Serialized
  • Comes with certificate of compliance
The cell holds the patch flat, with the release surface uppermost and parallel to the bottom of the paddle blade. A distance of 25 ± 2mm is maintained between the paddle blade and the surface of the patch. The temperature is maintained at 32 ± 0.5ºC. The vessel may be covered during the test to minimise evaporation

Procedure
Place the prescribed volume of the dissolution medium in the vessel and equilibrate the medium to the prescribed temperature. Precisely centre the patch in the cell with the releasing surface uppermost. Close the cell, if necessary applying a hydrophobic substance (for example, petrolatum) to the flat surfaces to ensure the seal, and ensure that the patch stays in place. Introduce the cell flat into the bottom of the vessel with the cover facing upwards.
Immediately rotate the paddle, at 100 r/min for example. At predetermined intervals, withdraw a sample from the zone midway between the surface of the dissolution medium and the top of the paddle blade, not less than 1 cm from the vessel wall.

Perform the assay on each sample, correcting for any volume losses, as necessary. Repeat the test with additional patches.
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