Gamlen Powder in two separate piles

USP <1062> TESTING SERVICE

The recently published USP Chapter <1062> Tablet Compaction Properties defines key Critical Quality Attributes for manufactured tablets. These are compressibility, tabletability and compactibility which are calculated from compaction pressure, tablet density or solid fraction and tensile fracture stress.

If you choose this service, we will measure all of these parameters for your chosen materials to provide you with useful compaction data. Using our unique powder assessment system, we will help you better understand your APIs, excipients formulations by meeting USP <1062> recommendations.

USP <1062> COMPACTION DATA WILL ENABLE YOU TO;

  • assess your formulations prior to manufacturing
  • troubleshoot manufacturing problems
  • compare compaction behaviour of materials from different suppliers
  • establish the intrinsic compaction behaviour of your APIs
  • support change control activities
  • reduce cost, limit material wastage and save time!
Compaction Triangle: compaction pressure - compressibility - solid fraction - compatibility - tensile strength -tabletability
Compressibility Profile Graph - showing majority of graph in green

Compressibility describes how tablet solid fraction changes with compaction pressure. High solid fraction values hinder water penetration reducing dissolution rate.

Tabletability Profile graph - showing an increase in green

Tabletability is the dependence of tablet strength on compaction pressure. We maximise tabletability to produce a robust tablet which will withstand handling.

Compatibility Profile Graph showing three quarters of the graph in green and one quarter in red

Compactability is the effect of solid fraction on tablet strength. We have to balance these properties to have strong tablets without over-compaction.

Software Graphs Key - showing good in green, borderline in yellow and poor in red