What is a Leachables?
Leachables are chemical species that make their way into the product under normal product, application or storage conditions. There is generally an overlap such that the leachables involved may be classified as a subset of the extractables.
What is leachables testing?
Extractables and Leachables Testing is an analysis of potentially harmful materials that could be administered to a patient with a drug or device. Medical device companies use it to show that materials of concern are not transferred from the device to the patient.
What is elemental impurity?
Elemental impurities are traces of metals that can be found in finished drug products. The analysis of elemental impurities is necessary to describe the concentration of the trace elements in final drug products. They can interfere with drug efficacy or elicit a direct toxic effect on the patient.
What are the different types of impurities?
The three different types of impurities in pharmaceuticals include organic, inorganic, and residual solvents. Most of these impurities occur due to manufacturing processes, degradation, storage conditions, excipients, or contamination.
What is elemental impurities testing?
Elemental impurities analysis encompasses trace metal/heavy metal testing to evaluate pharmaceutical products for elevated concentrations of elements such as lead and arsenic that are of significant toxicological concern. In any product, impurities can delay development or can cause a recall of a product on the market.
What’s the difference between a leachable and an extractable?
Leachables are chemical species that make their way into the product under normal product, application or storage conditions. There is generally an overlap such that the leachables involved may be classified as a subset of the extractables.
Which is the best definition of a leachable?
Leachable: Chemical species that migrate from a packaging/delivery system, packaging component, or packaging material of construction into an associated drug product formulation under normal conditions of use or during accelerated drug product stability studies. Leachables are typically a subset of extractables or are derived from extractables.
How are leachable studies used in extractable studies?
Extractable studies can also be used as a baseline to ensure SUS consistency over time. Leachable studies determine the chemical compounds that migrate from SUS into process solutions and characterize possible adsorption and/or absorption of process fluid (under normal process conditions).
When was FDA guidance on extractables and leachables published?
Extractable and leachable impurities from pharmaceutical container-closure and production systems. In May 1999, the U.S. FDA published a guidance document on Container Closure Systems for Packaging Human Drugs and Biologics. The FDA mandated that pharmaceutical manufacturers demonstrate the safety of materials used in production systems,…