Extractables and Leachables Analysis
Inquiry
The purpose of extractable and leachable analysis is to identify compounds in drug products that can cause potential toxicity issues. CD Formulation provides pharmaceutical companies with extractables and leachables analysis services, which involve identifying and quantifying any compounds that may migrate from packaging materials or processing equipment into the drug product that potentially impacts patient health, thus ensuring the safety and efficacy of their products.
The Importance of Drug Extractables and Leachables Analysis
Extractable and leachable analysis is a critical aspect of drug development and manufacturing that ensures the safety and efficacy of pharmaceutical products.
- Extractables: A class of compounds that can be extracted from a container closure in the presence of certain solvents.
- Leachables: A class of compounds that leach from the container closure into drug product formulation the drug product.
Extractables and leachables can be divided into the following broad groups:
- Non-volatile leachables
- Volatile leachables
- Semi-volatile leachables
- Inorganic/elemental leachable
Explore Our Extractables and Leachables Analysis Services
As the world's leading provider of CMC analytical testing services, CD Formulation provides our customers with unparalleled extractables and leachables analysis services for their pharmaceutical products. Our analytical services cover leachables and extractables analysis of various pharmaceutical products, including but not limited to tablets, capsules, injections, creams, patches, gels, etc.
Polar and non-polar extracts in pharmaceutical products are usually tested by differential analysis of organic compounds with a blank extraction matrix.
- Nonvolatile Compounds - Focus LC-UV/MS
- Volatile and Semi-Volatile Compounds - GC-MS
In addition, our expert team is also able to perform other analyses based on the properties of your product, including but not limited to elemental analysis and total organic carbon (TOC) analysis.
List of available Extractables and Leachables Analysis Services
- Develop custom study designs for extractable and leachable based on pharmaceutical standards.
- Extractables analysis (inorganic and organic extractable).
- Characterization of extractable by chromatography and spectroscopy.
- Conduct leachable studies or simulated use studies on finished products and dosage forms.
- Analytical method development and validation.
- Stability studies of leachable.
- Biocompatibility testing.
- Based on existing reporting and assessment results within current guidelines.
Available Analytical Techniques
- UPLC/HPLC (UV, PDA, Fluorescence, ELS, RI, CAD, MS, MS/MS).
- Gas Chromatography (liquid, headspace, solid-phase microextraction, FID, MS, MS/MS).
- Ion Chromatography (anions, cations).
- ICP-OES and ICP-MS.
- FT/IR.
- SEC/GPC.
- TOC.
Available Extraction Techniques
- Accelerated solvent extraction (ASE).
- Soxhlet extraction and reflux extraction.
- Static or dynamic liquid extraction by pumping.
- Ultrasonic extraction.
- Incubate under controlled temperature conditions.
- Stirring under controlled temperature conditions.
Available Morphological Characterization Techniques
- Thermal analysis (TGA/DSC).
- X-ray Fluorescence Analysis (XRF).
- Light microscope.
- Electron Probe Microanalyzer (EPMA).
- Reflection electron microscope (REM).
- Atomic force microscope (AFM).
- X-ray diffraction (XRD).
- X-ray photoelectron spectroscopy (XPS).
- Secondary ion mass spectrometry (SIMS-Tof).
Applicable Standards
Why Choose CD Formulation for Extractables and Leachables Analysis?
- Flexible, tailor-made solutions that adhere to extractables and leachables testing guidelines.
- Comprehensively understand the pharmacodynamic properties of raw materials, finished products and preparations to ensure that they meet specified standards and requirements.
- Reveal the potential chemical ingredients in APIs, finished products, and dosage forms to help evaluate their quality and efficacy.
- Extensive experience and expertise in extractables and leachables analysis to address complex analytical challenges.
- A wide range of analytical techniques and equipment to identify and quantify extractable and leachable in a variety of sample matrices.
CD Formulation has extensive experience and expertise in performing extractable and leachable analysis services. Our team of experienced scientists will work with you to develop a customized testing plan that meets your specific needs. Please contact us to learn more about how we can help you conduct extractable and leachable testing and verify the safety of your products to regulatory requirements.
Please note: Our products and services are not intended to be used directly in diagnostic or therapeutic procedures.
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