USP <787>: Application and Scope

  • Specifically for protein-based therapeutics (not all forms of injectables)
  • Analysis of final dose and packaging
  • Smaller test product volumes
  • Smaller test aliquots
  • Defines “inherent” form of particulate matter
  • Describes prep and test methods
  • Defines maximum particle burden limits

Although USP <787> focuses exclusively on protein-based formulations, there are a number of similarities between USP <787> and USP <788> (Particulate Matter in Injections) including:

  • Primary method: Light Obscuration1
  • Secondary method: Light Microscopy
  • Minimum number of aliquots = 4
  • Particle size thresholds ≥ 10 & ≥ 25 µm
  • Particle limits:
    • SVI: 6,000 & 600 per container
    • LVI (>100 mL): 25 & 3 per mL*

*Larger test volumes must also pass a container test. No more than 6,000 counts at 10 microns and no more than 600 counts at 25 microns.

1 Should the primary method not be applicable (e.g., preparations with reduced clarity or increased viscosity), microscopic particle testing should be carried out.

Помощь лабораториям в соответствии актуальным стандартам