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in > Analytical Services > Overview > Pharmaceutical > Extractables and Leachables |
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Pharmaceutical Analysis - Extractables and Leachables |
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This area of growing regulatory significance provides many challenges in the development and analysis of inhalation and injectable drug products.
Extractables are 'compounds that can be extracted from elastomeric, plastic compounds or coatings of the container and closure systems when in the presence of appropriate solvents under vigorous conditions.'
Whilst information may be available on the composition of the polymeric or rubber component from the manufacturer, this may be considered unreliable, incomplete and will not include information on extractable materials such as surface contaminants or materials absorbed into the component matrix over time as a result of processing and handling.
As a result of many years' experience we have defined a strategy for performing Controlled Extraction Studies which satisfies the PQRI requirements, whilst presenting the client with a highly cost effective and efficient approach to the Controlled Extraction Study.
Controlled Extraction Studies give information useful for on-going component quality monitoring, biological risk assessment and can identify components for Leachable Studies.Leachable compounds pose a risk in that they may influence the delivered dose, react with the active pharmaceutical or other formulated ingredients and hence compromise the efficacy of the drug product.
Experience in developing validated analytical methodology for quantitative study of leachable compounds allows our team accurately and efficiently to assess the accumulated level of the leachable species throughout the shelf life of the product.
This data can then be used to assess the biological risk posed by the accumulation of the potential migratory species. |
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| Efficient and Accurate Approach to Testing
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Controlled Extraction Studies Approach: |
| Compounds likely to migrate from container / closure systems might include: |
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- Monomers
- Initiators
- Antioxidants
- Antistatic Agents
- Heat Stabilisers
- Elastomers / Lubricants
- UV Absorbers
- Fillers
- Flame Retardants
- Modifiers & Coupling Agents
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- Extraction appropriate to component
- General Screen for Extractables Profile (GC-MS / LC-MS)
- Specific Screen for compounds of particular toxicological interest - Nitrosamines, PAHs,
2-Mercaptobenzothiazols
Appropriate Controlled Extraction Study using GC-MS (EI & CI), LC-MS (+ve & -ve)
Other supporting analysis and unknown characterization as required
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