RSSL’s experts will help you maximise the chance of a positive drug registration.

As part of your drug’s development and route to market, it is vital to identify both the substance and source of any leachables as they may significantly alter the identity, strength or quality of the drug. This, in turn, is a risk to patient safety.

Extractables and leachables testing and analysis is therefore critical in maintaining the quality of your drug product or combination drug delivery device, and there are a number of analyses which must be performed in order to comply with regulatory guidelines.

USP <1663> and <1664> provides guidance for the design of extractables and leachables studies, but do not set out methodology or specifications. Our analytical capabilities and technical expertise in performing these studies ensure that we provide the support you require to meet the regulatory requirements.

RSSL’s Bespoke Risk Based Approach

  • Profiling the extractables from the materials in contact with your drug product using our generic screening methods with:
    • 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

RSSL can provide analytical support during all stages of this process. We have performed controlled extractables and leachables studies on a wide variety of containers and closures using a range of analytical technologies (LC-MS, GC-MS, ICP-MS), and our specialists’ expertise and experience means you can rely on us to successfully set up and manage your project.

We perform work in accordance with GMP and work to safety evaluation thresholds recommended by the EMA and FDA.

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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