Extractables & Leachables

Volatile / semi-volatile and non-volatile extractables and leachables can be released or migrate from drug product container and closure systems. It is an FDA requirement to identify and to quantify these contaminants in drug products at release and on stability. Examples of these extractables and leachables are as follows:

Monomer and plasticizer
Antioxidants and other additives
Coatings
Accelerants and vulcanizing agents

Extractables and leachables are identified by the latest LC/MS/MS, LC/CAD and GC/MS technologies. Accurate and precise methods are developed and validated using HPLC, GC and IC.

Parameters such as, potency, pH, discoloration and degradation are monitored to determine extractable and leachable-induced changes that may adversely affect the quality of the product.

Extractables and leachables can be determined for packaging components, inhalation devices, metered dose inhalers, injectables, implant devices, ocular and nasal products.

Comprehensive analysis and reporting to our client ensures compliance and acceptance by FDA!