Extractables and leachables are terms used in the pharmaceutical industry to describe potential chemical compounds that can migrate from packaging materials, manufacturing equipment, or drug delivery devices into the pharmaceutical product.
Extractables refer to chemical substances that can be extracted from a material under controlled laboratory conditions. These substances may include residual solvents, processing aids, lubricants, antioxidants, or other additives present in the packaging materials or manufacturing equipment. Extractable studies are conducted to identify and quantify these potential compounds.
Leachables, on the other hand, are chemical substances that migrate from packaging materials or manufacturing equipment into the pharmaceutical product under normal conditions of storage or use. These compounds may include degradation products of packaging materials, impurities from manufacturing processes, or contaminants introduced during storage or transportation. Leachable studies aim to identify and quantify these compounds in order to assess their potential impact on patient safety and product quality.
Extractable profile for a given packaging component, typically can be a chromatogram (GCMS, LC-MS and ICP-MS) representing all possible extractables. Extractable profile is established for all packaging components (resin, vial, foil-laminate) for their consistent quality assurance.
The identity and concentration of recurring leachables in the drug product or placebo formulation should be determined through the end of the drug products shelf life.
An extractable can be a leachable.
Both extractables and leachables are important considerations in the pharmaceutical industry as they can potentially affect the efficacy, stability, and safety of pharmaceutical products. Regulatory authorities require manufacturers to conduct extractable and leachable studies as part of their overall risk assessment and quality control processes to ensure patient safety.
A Process Flow of Exctractable and Leachable Study
Material Assessment > Extractables Study (AET) > Simulation Study (AET) > Toxicological Assessment > Leachables Study (AET, SCT, TTC, QT).
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