Extractables and Leachables Studies

Extractables and leachables studies play a vital role in the characterisation of many pharmaceutical and healthcare related materials and products. Extractables / Leachables studies are applied to a wide variety of materials and products. Examples include: drug delivery systems such as pre-filled syringes or Orally Inhaled and Nasal Drug Products (OINDP) through to cell culture and bioprocessing systems including single use disposable equipment, bioprocess containers and disposable bags of medical grade film used to transport, dispense and store pharmaceutical products. Using properly defined conditions, extraction studies provide both qualitative and quantitative information which is used to build a comprehensive profile of extractable components that exist in the material or materials under study. Leaching studies demonstrate quantitatively the extent to which a potentially extractable component actually contaminates a drug substance or product.

Intertek Pharmaceutical Services can develop protocols and conduct experimental programmes to meet current industry guidelines (e.g., FDA and PQRI) or, alternatively, can provide custom programmes to fulfil the specific customer requirements of an Extractables / Leachables study. If required studies can be conducted to GLP standards and services include:

• Design of study protocols and experimental programmes.

• Controlled Extraction Studies (CES) performed using different polarity solvents to provide a comprehensive extractables profile.

• Development of analytical methods including; LC-MS, GC-MS and ICP-OES for the identification and quantification of organic and inorganic components generated during the CES.

• Identification of ‘special case’ compounds in OINDP’s, e.g., Polyaromatic Hydrocarbons (PAHs), N-nitosamines and 2-mercaptobenzothiazole.

• Adaptation and development of CES analytical methods for use in leaching studies to assess the degree of drug substance or drug product contamination.

• Application of leachables analysis during long term drug substance or drug product storage stability trials.

• Routine extractables testing for quality control purposes.

Analytical Method Development and Validation

To provide the highest degree of confidence, analytical methods for Extractables / Leachables studies should be validated according to accepted parameters and criteria. Intertek Pharmaceutical Services offer a full method development and validation service in accordance with current ICH guidelines.

Further information:

• Analytical Services
• Services A-Z