Extractables and Leachable

Home Services Extractables and Leachable

All the services you expect from a clinical trial lab

Regulatory agencies recommend the risk evaluation of all the packaging materials used for the storage of drug products. This includes all the primary, secondary as well as tertiary packaging materials.

Medical devices are also required to be evaluated for the potential risk assessment based on the chemical characterization.

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam.
Lab technicians
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam.
Research Center

Led by passionate experts

Extractable

Chemical species that can be released from a pharmaceutical packaging/delivery system, packaging component, or packaging material and medical devices of construction under laboratory conditions including extraction solvent, technique, stoichiometry, temperature, and duration. Extractables themselves, and/or substances derived from extractables, have the potential to leach into a drug product formulation under normal conditions of storage and use.

Leachable

Chemical species that migrate from a packaging/delivery system, packaging component, or packaging material of construction or medical devices into an associated drug product formulation under normal conditions of use or during accelerated drug product stability studies. Leachable are typically a subset of extractables or are derived from extractables.

  • Extractables studies in-line with the PQRI guidelines USP <1663> BPOG for various drug dosage forms as well as ISO 10993 guidelines for medical devices.
  • Analytical method development and validation for extractable and leachable compounds.
  • Toxicological assessment of extractable and leachable compounds.
  • Leachable monitoring in the stability samples of the drug products in-line with USP <1664>.

Opening Hours

Visit us at our headquarters for a free consulting hour.

Mon – Fri
10.00 – 20.00
Saturday
9.00 – 16.00
Sunday
Closed

Get Social