Confident Tentative Field Pdf For Free

AET is defined by the International Organization for Standards (ISO) as ?a threshold below which the analyst need not identify or quantify leachables or report them for potential toxicological assessment?.

USP chapter <1663> describes the risks of extractables in pharmaceutical packaging and delivery systems. This chapter includes the definition of extractables, why testing should be carried out, where extractables can occur, and information on testing procedures.

Extractables ? Compounds that can be extracted from the container closure system when in the presence of a solvent. Leachables ? Compounds that leach into the drug product formulation from the container closure as a result of direct contact with the formulation.

The FDA defines the two terms as follows: Extractables are compounds that can be extracted from the container closure system when in the presence of a solvent. Leachables are compounds that leach into the drug product formulation from the container closure system as a result of direct contact with the formulation.

Extractables and leachables testing is critical to the identification and quantification of potentially harmful leachable impurities which could migrate from pharmaceutical container closure systems to contaminate a pharmaceutical product and so pose a risk to a patient's health and cause significant quality issues.

Leachable would have a dose so low as to present negligible safety concerns from carcinogenic and non-carcinogenic toxic effects. The safety concern threshold (SCT) for extractables and leachables has been defined as 0.15 µg/day.