Elemental Impurities Analysis
Leverage our expert analytical services to detect impurities at levels as low as parts-per-trillion.
Expert Elemental Impurity Determination
SK biotek Ireland Analytical Services have decades of experience in elemental analysis and trace metal testing for quality control. Our fully GMP-compliant labs are equipped with the latest analytical techniques — enabling us to deliver accurate results, fully compliant with regulations.
Techniques we specialise in include:
ICP-OES (Inductively Coupled Plasma-Optical Emission Spectrometry)
Material Characterisation (including particle size and thermal analysis)
ICP-MS (Inductively Coupled Plasma-Mass Spectrometry)
X‐ray Diffraction and Foreign Matter Identification
NMR (Nuclear Magnetic Resonance) Spectroscopy
Chromatography
The SK biotek Ireland Analytical Services Advantage
SK biotek Ireland Analytical Services is a subsidiary of SK pharmteco, a company with a legacy of providing value-added services to a wide range of clients. With us, your product testing for impurities is in the right hands!
Customised Approach That Meets Demand
Each client has specific requirements, and we recognise that. Our approach to impurities analysis addresses these needs through collaboration with our customers to realise the best outcomes.
Regulation Compliant analyses
We ensure that the methods we design are in accordance with ICH Q3D guidelines and aligned with United States Pharmacopeia (USP <232> and <233>) and European Pharmacopeia (Ph. Eur. 5.20 and 2.4.20).
60 Years of Trust
We leverage our multiple decades of experience in analysing and handling drug substances when developing methods. Over the years, we have worked on various sample types and assisted numerous drug companies in regulatory compliance.
Modern Instrumentation, Talented staff
Our international network of laboratories is equipped with a full complement of modern instrumentation. This includes ICP‐MS, ICP‐OES, NMR spectroscopy, and powder X‐ray diffraction (PXRD) among others. Our talented workforce has the expertise and experience to effectively utilise this state-of-the-art equipment.
End-to-End Service
We offer a full suite of analytical techniques to support the analysis of drug substances and intermediates including HPAPIs. Our talented scientists provides all-around material characterisation in an end-to-end approach.
Uncompromised Quality
SK biotek Ireland Analytical Services support all our client’s regulatory needs. We provide accurate results down to trace levels, using a risk-based approach for the evaluation and control of elemental impurities.
Let Us Support Your Journey as Your Compounds Evolve From Drug Substance to Drug Product
Expertise, capabilities and flexibility are key facets of SK biotek Ireland Analytical Services.
Our analytical techniques, utilised by our highly experienced and skillful analysts, take your compound to the next level with ease. SK biotek Ireland Analytical Services provide a full material characterisation with an end-to-end approach.
With SK biotek Ireland Analytical Services, you gain a partnership that fosters growth.
