Related Experiment Videos
Method for determination and element analysis of particulate contamination in injectable solutions
American Journal of Hospital Pharmacy
|November 1, 1976
Summary
A new method effectively samples and analyzes particles in injectable solutions, identifying potential medical hazards. This technique uses scanning electron microscopy (SEM) for detailed particle characterization, crucial for pharmaceutical quality control.
Area of Science:
- Analytical Chemistry
- Materials Science
- Pharmaceutical Science
Background:
- Particulate matter in injectable solutions poses risks to patient safety.
- Accurate identification of particle sources and composition is essential for quality control.
Purpose of the Study:
- To develop and validate a method for sampling and evaluating particles in injectable solutions.
- To identify the sources and potential medical hazards associated with these particles.
Main Methods:
- Particles > 0.2 µm collected on membrane filters suitable for scanning electron microscopy (SEM).
- Developed a sampling device to minimize contamination and reduce filter-solution distance.
- Analyzed particles using SEM with X-ray analysis after gold coating.
Main Results:
- SEM analysis identified various elements including silicon, aluminum, calcium, chromium, copper, iron, magnesium, manganese, and chlorine.
- Distinguished between inherent filter elements and contaminants from the saline solution.
- Demonstrated the method's capability to detect and characterize particulate contaminants.
Conclusions:
- The developed method provides a reliable approach for particle analysis in injectables.
- Recommendations are provided for standardizing particle detection procedures in large-volume parenteral products.
- This technique aids in ensuring the safety and quality of pharmaceutical injectables.