A REVIEW ON EXTRACTABLES AND LEACHABLES OF DIFFERENT PACKAGING MATERIALS
AVV. Indumani, K. Maheshwari, I. Sahithi, *Dr. P. Sridevi and M. Bhagavan Raju
ABSTRACT
Extractable and leachable (E&L) impurity testing is crucial for toxicological risk assessment in pharmaceuticals, bioprocess manufacturing systems, and medical devices. Challenges include complex matrices, low analyte evaluation thresholds, and high-resolution chromatography instruments. Obtaining consistent, high-quality data requires multiple systems.
Keywords: Leachables, Extractables, GC, LC.
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