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Errors in particle size and concentration analysis of pharmaceuticals
1Delft University of Technology, Delft, The Netherlands.
Pharmaceutical Development and Technology
|November 8, 2019
Summary
Minimizing particle segregation and ensuring representative sampling are crucial for quality control of particulate products. This involves optimizing procedures and equipment for sampling and measurement to reduce errors in powder lots and pharmaceutical tablet production.
Area of Science:
- Materials Science
- Analytical Chemistry
- Quality Control
Background:
- Particulate products require minimized particle segregation for consistent quality.
- Representative sampling is essential for effective quality control of bulk materials.
- Inadequate sampling procedures can lead to inaccurate quality assessments.
Purpose of the Study:
- To discuss potential errors in sampling particulate materials.
- To provide guidance on designing adequate analytical procedures for sampling and measurement.
- To highlight the similarities in sampling errors between powder lots and pharmaceutical tablet production.
Main Methods:
- Discussion of potential errors in small-amount collection from powder lots.
- Analysis of errors during in-situ and on-line measurement of particulate materials.
- Exemplification of sampling and measurement challenges.
Main Results:
- Identified various potential errors during the collection of small amounts from powder lots.
- Highlighted errors that can occur during in-situ and on-line measurements.
- Demonstrated that sampling errors in particulate materials mirror those in pharmaceutical tablet production.
Conclusions:
- Optimizing the design of sampling and measurement procedures is critical for quality control.
- Understanding and mitigating sampling errors are key to achieving representative test samples.
- The principles discussed are applicable to both general particulate materials and pharmaceutical manufacturing.
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