Pharmaceutical Particulate Analysis
Particulate contamination poses a risk to the safety and efficacy of pharmaceutical formulations, especially in injectables, infusions, and parenteral products. On this page, we'll explore the importance of particulate analysis, the methods used for testing, and its significance in ensuring product quality and patient safety.
Particulate contamination refers to the presence of foreign particles, both visible and sub-visible, in pharmaceutical products. These particles can originate from various sources, including raw materials, manufacturing processes, packaging, or environmental conditions.
Importance of Particulate Analysis
Particulate analysis is crucial for several reasons:
Patient Safety
Particulate contamination can pose health risks to patients, including embolism, tissue irritation, and immune reactions. Analysing and controlling particulate levels are essential for ensuring product safety and minimising adverse effects.
Product Quality
Particulate contamination can affect the physical appearance, stability, and efficacy of pharmaceutical formulations. Analysis helps maintain product quality and consistency, meeting regulatory standards and specifications.
Regulatory Compliance
Regulatory authorities, such as EU Pharmacopeia (e.g. EP), require comprehensive particulate analysis for injectable and parenteral products. Compliance with regulatory guidelines is essential for market approval and patient acceptance.
Our Method for Pharmaceutical Particulate Analysis
Light Obscuration Particle Count Test
This method involves passing a sample through a calibrated light beam, which detects and counts particles based on the degree of light obscuration. It is particularly suitable for quantifying sub-visible particles (SVPs) in injectable and parenteral products.
Conducting Pharmaceutical Particulate Analysis
The process of particulate analysis involves the following steps:
1. Sample Preparation: The pharmaceutical sample is prepared according to standardised procedures, ensuring it is representative and suitable for analysis.
2. Light Obscuration Particle Count Test: The prepared sample is introduced into the particle counter, and the number and size distribution of particles are determined based on the light obscuration principle.
3. Data Interpretation: The obtained results are compared against established limits and specifications. Any deviations may require investigation and corrective actions to mitigate risks and ensure product quality.
At Tentamus Pharma UK, we are committed to providing Pharmaceutical Particulate Analysis. Our goal is to support the pharmaceutical industry in delivering safe, effective, and high-quality products to the market.
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