Drawing on the expertise of RSSL in areas such as method development and validation, physical sciences, stability testing, microscopy, metals analysis  and flavour analysis, our dedicated and knowledgeable teams have the capability, techniques and equipment to support a wide range of formulation types throughout the drug development lifecycle from early phase to finished product release and import testing.

As companies focus on achieving ever shorter timescales of drug to market, it is vital that a tailored pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API), Drug Product (DP) or Medical Device .

Successfully developed and validated analytical methods can reduce overall turnaround times spanning from pre-clinical right through to commercial release, with a well-developed method underpinning a robust product. Starting with the end point in mind, methods would have the desired flexibility built in during the early stages to allow easy translation from API to DP, thus potentially reducing costs throughout the product life cycle.

Method Development

With 20 years of experience working with a diverse client base and a multitude of different dosage forms means we can support you on developing robust, fit-for purpose methods appropriate for potency, purity, physical characteristics and stability.

Our specialists offer a wealth of knowledge and advice on areas ranging from sample preparation and extraction techniques to regulatory requirements and specialised methodology.

Method Validation

Following successful method development, we can perform Phase appropriate method validation according to the ICH Q2 (R1) recommendation for the analytical procedure. We can also validate methods developed by other laboratories, and perform a gap analysis of previously validated methods to ensure they meet the current guidelines and maximise the success for a regulatory filing.

Our cross-laboratory, multi-disciplinary approach, combined with exemplary customer focus and communication, make us an ideal partner for method development and validation activities. You can trust us to manage projects effectively and achieve key milestones.

Method parameters include (based on ICH guidelines):-

  • Specificity
  • Limits of detection and quantification
  • Linearity
  • Accuracy
  • Precision
  • Solution stability

Techniques

UltraViolet-Visible (UV/VIS)

High-Performance Liquid Chromatography (HPLC) with UV. Diode Array (DAD), or Fluorescence Detection (FLD)

Gas Chromatography with Flame Ionisation Detection (GC-FID)

Gas Chromatography-Mass Spectrometry (GC-MS)

Ion Chromatography with Conductivity Detection (IC-CD)

High-Performance Anion Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD)

Liquid Chromatography-Mass Spectrometry (LC-MS)

Atomic Absorption Spectroscopy (AAS)

Inductively Coupled Plasma Mass Spectrometry (ICP-MS)

Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES)

Laser Diffraction (Mastersizer 2000 and 3000)

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