Extractables & Leachables Test
Extractables and leachables are chemicals that migrate from packaging system components, such as containers and closed systems, and may contaminate the drug. In drug development, it is important to assess the potential for the migration of chemicals from containment systems, manufacturing components or delivery devices into the drug product, as these substances are sufficient to cause toxic hazards or affect the stability and efficacy of the drug. Therefore, the regulatory agency requires extractables and leachables (E&L) testing to ensure the quality of the drugs.
Extractables: they are compounds that migrate from the contact surface under more aggressive conditions, such as elevated temperature, extended contact time, or aggressive solvent system.
Leachables: they are compounds that migrate from the contact surface under normal conditions of exposure.
CD Formulation laboratory is cGMP-compliant and equipped with state of the art analytical instruments. We have experienced analysis experts who can work with our formulation and manufacturing team to provide you with extractables & leachables test services. Our E&L test is performed in accordance with pharmacopeia methods, in particular USP chapters <1663>, <1664>, and <1664.1>. The accurate and robust data generated of the E&L test, which can help you to anticipate and identify potential sources of risk that in drugs. In addition, we are also able to develop and validate tailored methods of the E&L test that will meet your specific needs.
Our Extractables & Leachables Test Services
We can provide you with the following materials E&L test.
| Type | Materials |
| Manufacturing | Filters |
| Single-use bags | |
| Tubing | |
| Primary packaging - External components | Container-closure system (vials, caps, lids and foils) |
| Single-use systems (syringes and intravenous bags) | |
| Primary packaging - Internal components | Gaskets and O-rings |
| Valves | |
| Springs | |
| Secondary and tertiary packaging | Labels and adhesives Inks and colourings |
The Potential Extractables & Leachables During Drug Manufacture and Storage
|
|
|
|
|
|
|
|
Our Methods of Extractables & Leachables Test
Extractable and leachable studies need to use a range of analytical technologies
| Compounds | Methods |
| Volatile organic compounds | Headspace GC-MS |
| Semi-volatile organic compounds | GC-MS or high resolution accurate mass (HRAM) GC-MS |
| Non-volatile organic compounds | HRAM LC-MS/MS |
| Elemental impurities (metals) | ICP-MS |
Deliverable
- Analysis critical components of the primary packaging, covering inorganic and organic extractables
- Extractables profiling (inorganic and organic extractables)
- Determination of the Analytical Evaluation Threshold (AET)
- Test strategy planning and data evaluation based on the available information
- Others data analysis that you need
- Provide full study report, containing full results and chromatograms
Our Advantages
If you have a requirement about E&L test services, please contact us by phone or email, our colleagues will reply to you within three working days.
References
- Ding W. Determination of Extractables and Leachables from Single‐Use Systems[J]. Chemie Ingenieur Technik, 2013, 85(1‐2): 186-196.
- Markovic I. Regulatory Perspective on Safety Qualification of Extractables and Leachables[C]//FDA PQRI PODP Workshop. 2011.
Easy access to products and services you need from our library via powerful searching tools.