Extractables & leachables

To help you maintain the quality of your drug product or combination drug delivery device, RSSL can conduct in-depth extractables and leachable studies.

 

It is vital to identify both the substance and the source of any leachable impurities throughout drug development and release. Identifying impurities is key as they may significantly alter the identity, strength or quality of the drug and pose a risk to patient safety. These impurities may come from many different sources, including pharmaceutical container systems and product packaging. 

 

There are a number of analyses that must be performed in order to comply with the regulatory requirements USP <1663> and <1664>.  However, these requirements only provide guidance for the design of extractables and leachables (E&L) studies and do not set out precise methodologies or specifications. As a result, E&L studies must be designed specifically for your drug product and the container materials.  

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Bespoke extractables and leachables studies

 

RSSL offers bespoke E&L studies, providing the necessary analytical data for regulatory submission and helping to maximise the chance of a positive drug registration.

 

We have experience performing controlled E&L studies on a wide variety of containers and closures using a range of analytical technologies.

 

Additionally, our specialists’ project management expertise means you can rely on us to successfully set up and manage your project.

 

Our work is carried out in accordance with GMP and to the safety evaluation thresholds recommended by the EMA and FDA. 

 

  • Pharmachem RD 4821 HR

    Bespoke E&L risk-based approach

    • Profiling the extractables from the materials in contact with your drug product using our generic screening methods with: 
    • A selection of suitable extraction media 
    • Analysis for organic and inorganic extractables 
    • Stability storage of products 
    • Method optimisation (if required) and validation for quantification of significant leachables in the specific drug product matrix 
    • Analysis of product for organic and inorganic leachables over a number of timepoints 
    • Identification of impurities above the safety threshold 
    • Toxicological support for evaluation of leachables of concern 
  • Istock 623208264 (1)

    Techniques

    • Gas Chromatography-Mass Spectrometry (GC-MS) with Chemical Ionisation (CI) and Electron Impact (EI) Sources and Direct and Headspace Injection  
    • Gas Chromatography-Nitro Chemiluminescence Detection (GC-NCD)  
    • Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)  
    • Inductively Couple Plasma-Optical Emission Spectroscopy (ICP-OES)  
    • Liquid Chromatography-Mass Spectrometry (LC-MS) (including Quadrapole Time of Flight (Q-TOF) and Quadrapole Orbitrap systems)  
    • Liquid Chromatography-Diode Array UV Detection (LC-DAD)  
    • Nuclear Magnetic Resonance (NMR)  
    • Fourier transform infrared spectroscopy (FTIR)   
    • On-site stability storage for leachables studies  

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