Pharmaceutical Method Development and Validation
Choose us as a partner for method development and validation, and you gain access to an experienced, specialist multi-disciplinary team. For both APIs and drug products, we have the capabilities to support you through the entire drug lifecycle.
Our cross-laboratory, multi-disciplinary approach, combined with exemplary customer focus and communication, makes us an ideal partner for method development and validation activities. You can trust us to manage projects effectively and achieve key milestones.
We understand that as companies focus on achieving ever shorter timescales of drug to market, a tailored and pragmatic approach is vital in both Active Pharmaceutical Ingredient (API), Drug Product (DP) and medical device method development and validation activities. Many years of experience working with a diverse client base and multitude of different dosage forms means we can guide and advise you on developing robust, fit-for purpose methods appropriate for the specific phase of the development life-cycle. Our specialists offer a wealth of knowledge and advice on areas ranging from sample preparation and extraction techniques to regulatory aspects.
Following successful method development, we can perform method validation in line with an approved protocol at a level that reflects the ICH requirements for the particular project type and stage of API/DP development.
Techniques available include:-
- 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)
Method parameters include (based on ICH guidelines):-
- Limits of detection and quantification
- Solution stability