Intertek Extractables and Leachables Capabilities for the Pharmaceutical Industry include:

• Organic and Inorganic components
• Develop HPLC, GC, and ICP methods for controlled extractables from pharmaceutical containers, closures and devices.
• Identify extractables using GC/MS and LC/MS, obtain a profile.
• Modify appropriate controlled extractable methods for use in routine extractable testing.
• Validate the routine extractable methods for product release.
• Modify appropriate controlled extractable methods for use in leachables testing.
• Obtain a leachables profile.
• Validate the leachables method for incorporation into a stability program.

Additive Solutions:

• Comprehensive additive identification and characterisation capabilities in the lab.
• Identify and characterise additives in solid polymer and plastic materials.
• Additive leaching studies for food contact and food packaging projects.
• Additive leaching studies for pharmaceutical contact and pharmaceutical packaging projects.
• Identification and measurement of trace impurities and contaminants.

Examples of drug delivery devices, medical devices, product types and packaging materials for testing include:

• Metered dose inhalers (MDI's)
• Dry powder inhalers (DPI's)
• Aerosols and nasal sprays
• Implantable devices
• Injectables
• Solid, liquid and paste formulations
• Plastic containers and closures
• Valves and elastomer seals
• Syringes
• Labels

Additives Characterised by Intertek:

• Antioxidant additives
• Dispering agent additives
• Cross-linker additives
• Anti-microbial additives
• Dye additives
• Pigment additives
• Fillers additives

Analytical Techniques Available:

• GC/MS, Gas Chromatography Mass Spectrometry
• Pyrolysis GC/MS
• HPLC/MS
• Elemental Analysis
• Other techniques in the Intertek pharmaceutical laboratory network

• Intertek Services for Extractables and Leachables Studies, .pdf