Extractables & Leachables Testing
Filters, containers and other components made of plastic or elastic materials are widely used in pharmaceutical production. When these components are in direct contact with process intermediates and final drugs, some compounds will migrate into the solution. Extractable compounds are compounds that can be extracted from plastics or elastic materials by solvents with different physical and chemical properties under certain conditions. Leachables are compounds that migrate from plastic or elastic materials into drugs under normal conditions of use. GPM guidelines around the world require that the surface in contact with the drug should not be reactive, additive or absorbent, so that the safety, strength, purity or quality of the drug changes and does not meet official requirements or other regulations. T,C&A Lab runs strictly in accordance with GMP and GLP standards to meet the relevant requirements of compliance, quality, efficiency, etc. We can perform extractables & leachables testing according to industry standards. Welcome to contact our experts for consultation.
Have you encountered the following problems in the pharmaceutical process
- What are the acceptance criteria for the amount of extractable and extractable substances?
- Is the amount in test report within the acceptable range?
- Faced with various infrared and liquid phase spectra, and various compounds detected, do you feel that you have no way to start?
If you are suffering from the above troubles, welcome to T,C&A, which is a one-stop third-party material testing laboratory that can help you solve them all.
Our testing scope includes but not limited to
- Pharmaceutical packaging
- Device packaging
- Container closure systems
- Drug delivery systems
- Implantables
Our extractables & leachables testing items include
- Non-volatile leachables
- Volatile and semivolatile leachables
- Inorganic / elemental leachables
Our testing techniques include but are not limited to
- Nuclear Magnetic Resonance Spectroscopy (NMR)
- High Performance Liquid Chromatography (HPLC)
- Gas Chromatography - Mass Spectrometry (GC-MS)
- Inductively Coupled Plasma Massspectrometry (ICP-MS)
- Liquid Chromatography - Mass Spectrometry (LC-MS)
- Fourier Transform Infrared Spectroscopy (FTIR)
- UV/Vis Spectroscopy
Standards we test to
- USP<1663>, USP<1664>, USP<661>
- ISO 10993
- FDA 21 CFR 211.94(a)
- European Commission Directive (2001/83/EC)
In addition, the experts in our Extractables & Leachables Testing Laboratory also provide a variety of custom services as your needs and requirements. Let's discuss the custom services with our experts for free.
Instruments and data
Reference
- Lukas, B.; et al. Combined LA-ICP-MS/LIBS: powerful analytical tools for the investigation of polymer alteration after treatment under corrosive conditions. Scientific Reports (Nature Publisher Group) 10.1 (2020).
T,C&A Lab's services include, but are not limited to
Note: this service is for Research Use Only and Not intended for clinical use.
Related testing services
Ingredient Analysis
Structure Identification
Morphology & Size
Material Properties
Corrosion Testing
Mechanical Testing
Composite Testing
Non-Destructive Testing
Material Characterization
Performance Testing
Polymer Material Analysis
Pharmaceutical Analysis
Metallurgical Analysis
Restricted Substances Testing
Reverse Engineering Service
Industrial Diagnosis
Adhesive Testing
Coatings Testing
Graphene Testing
Ink Testing and Analysis
Leather Testing
Nonwoven Materials Testing
Pulp and Paper Testing
Plastic Testing
Resins Testing
Rubber Testing
Surfactant Testing and Analysis
Textile Testing
Metal and Alloys Testing
Ceramics Testing
Glass Testing
Liquid Crystal Testing
Composite Materials Testing
Nanomaterials Characterization
Rock Testing
Wood Testing
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Material Testing
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Ingredient Analysis
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Corrosion Testing
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Metallurgical Analysis
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Ingredient Analysis
