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What are the main sections of USP <1787>?
There are three main sections: Size and Distribution, Size and Morphology and Characterization.
Each provides a description as well as the advantages/disadvantages of various techniques. Particle categories are also defined and covered.
External to the process
Material not part of the formulation, package or assembly process
Glass, stopper fragments, metals, silicon oil, filter/process particles, clothing or hair fibers, skin flakes, dirt particles
Part of the process or product itself
Material from sources involved in formulation, packaging or assembly processes
Active ingredients, ingredient degradation, protein aggregation, ingredient anomalies, other process-related particles
Part of the formulation
Material expected from drug substances and formulation components
Certain excipients, mannitol crystallization, proteinaceous aggregates, adjunctive material in suspension
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NOT ALL PRODUCTS ARE AVAILABLE IN ALL COUNTRIES.
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.