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ASPEX EXplorer™

Reported Information

USP <788>

The United States Pharmacopoeia (USP) Test Section <788>, USP 788 defines the allowable limits of particulate matter in parenterals. Specific limits are set forth for particles above 10 and 25μm. The ASPEX Rx is the ideal tool to perform automated Microscopic Particle Count Testing of an entire sample deposited on a filter membrane.

<788> Microscopic Particle Counting Specifications

Particle Size Distribution Analysis

The ASPEX Rx allows the automated enumeration and classification of sub-micron particulate material (organic and inorganic) in drug powders and suspensions. Perception Suite with Tabular Reporter is used for easy data mining and to create particle size distribution and chemistry tables.

Particle Counts and Classification in Drug Powder

Particle size distribution tables

Automated Particle Counting Results

Particle Morphology and Shape

The ASPEX Rx is used to evaluate the shape and morphology of sub-micron particles. SED and BSED images illustrate that micronization, jet milling and spray drying processes resulted in the desired particle size and shape.

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