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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:
Light Obscuration 1 Secondary method: Light Microscopy
Minimum number of aliquots = 4
Particle size thresholds ≥ 10 & ≥ 25 µm
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.
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PRODUCT AVAILABILITY AND REGULATORY STATUS DEPENDS ON COUNTRY REGISTRATION PER APPLICABLE REGULATIONS
The listed regulatory status for products correspond to one of the below:
IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use."
ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagents. Analytical and performance characteristics are not established."
CE: Products intended for in vitro diagnostic use and conforming to European Directive (98/79/EC). (Note: Devices may be CE marked to other directives than (98/79/EC)
RUO: Research Use Only. These products are labeled "For Research Use Only. Not for use in diagnostic procedures."
LUO: Laboratory Use Only. These products are labeled "For Laboratory Use Only."
No Regulatory Status: Non-Medical Device or non-regulated articles. Not for use in diagnostic or therapeutic procedures.