API Synthesis

API Synthesis

Extractables, Leachables, and Nitrosamines: Where Pharmaceutical Packaging Risk Assessments Commonly Miss Risk

Extractables, Leachables, and Nitrosamines: Where Pharmaceutical Packaging Risk Assessments Commonly Miss Risk

Pharmaceutical packaging systems are designed to protect products throughout manufacturing, storage, transportation, and patient use. As a result, packaging risk assessments have become a routine part of pharmaceutical development and quality management programs. However, one important challenge remains: not all packaging-related risks are immediately visible. While many packaging assessments focus on material compatibility, stability, and […]
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How Elemental Impurities Testing Supports ICH Q3D Compliance

How Elemental Impurities Testing Supports ICH Q3D Compliance

Elemental impurities may be present at trace levels, but in pharmaceutical products they can create significant safety, quality, and regulatory risk. These impurities can come from raw materials, catalysts, excipients, manufacturing equipment, container systems, or process-related contamination. That is why elemental impurities testing has become an important part of modern pharmaceutical quality control. It is […]
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