V:Kit 5 Tablet Dissolution

green banner illustrating v kit 5 for tablet dissolution qualification

V:Kit 5 Tablet Dissolution (TD) will qualify stand-alone, manual baths; baths with HPLC systems; baths with UV-Vis spectrophotometers.

V:Kit TD is supplied with standard OQ protocols complying with:

  • ASTM E 2503-07 - Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus
  • FDA Document: DPA-LOP.002 - Mechanical Qualification of Dissolution Apparatus 1 and 2.
    • European Pharmacopoeia Ph.Eur 2.9.3. Dissolution
    • Japanese Pharmacopoeia JP 6.10. Dissolution Test
    • United States Pharmacopoeia USP (711) Dissolution

V:Kit 5 Tablet Dissolution qualification test summary:

Performance Verification Testing (PVT)

  • USP calibrator
    • Prednisone

Mechanical Qualification Testing (MQT)

  • Vessels
    • Shaft verticality
    • Vessel verticality
    • Shaft centering
    • Temperature
  • Paddles
    • Shaft wobble
    • Height
    • Rotational speed
  • Baskets
    • Basket wobble
    • Height
  • Environmental
    • Significant vibration
    • Bath cleanliness
    • Basket, paddle & shaft examination

View other techniques

Link to page showing V:Kit 5 HPLC qualification tests summary
visit page for V:Kit 5 GC & GCMS qualification tests summary

V:Kit 5 Tablet Dissolution

S5 Box