Release Testing
Utilise SK biotek Ireland Analytical Services’ comprehensive analytical release testing support for all phases of drug development and commercial manufacturing.
Reliable Release Testing & Analytical Services
Our labs are equipped to handle not only typical APIs and Intermediates but also hazardous and cytotoxic/high potency compounds.
Our Release Testing Services Include:
Appearance/Description
Infrared Spectroscopy – FTIR/ATR, Salt Pellets and Salt Plates (for liquids)
Nuclear Magnetic Resonance Spectroscopy (NMR)
Liquid Chromatography – HPLC and UHPLC (normal phase and reverse phase)
Gas Chromatography (GC/HSGC)
Ion Chromatography (IC)
Mass Spectrometry (MS, LC-MS, LC-QToF, GC-MS)
Ultra Violet Spectroscopy (UV)
X-ray Powder Diffraction (XRPD)
Residue On Ignition/Sulfated Ash
ICP-MS and ICP-OES for Elemental Impurities
Particle Size Distribution (Wet and Dry)
Karl Fisher
Various Compendial Tests
The SK biotek Ireland Analytical Services Advantage
SK biotek Ireland Analytical Services provide multifaceted expertise to support diverse client needs.
Value-Oriented Assistance
With our vast knowledge in product release testing, technical competence, industry experience, and capabilities, SK biotek Ireland Analytical Services ensure you gain the best possible value with our service.
60 Years of Experience
We have 60 years of expertise in release testing drug substances. We have a wealth of experience conducting complete release testing on commercial drug substance and clinical trial materials.
Bespoke Methodology
We tailor our Release Testing programs to your requirements and can provide services for the most basic of tests through to the most specialised of techniques.
State-Of-The-Art Equipment
SK biotek Ireland Analytical Services have advanced equipment to support your release testing requirements. We also have dedicated high containment labs equipped to handle hazardous and cytotoxic/high potency compounds.
Recognised Quality Assurance
With a focus on safety first, and quality always, we offer total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
Pharmacopeial Testing
We can successfully qualify and implement monographs and testing chapters from the various pharmacopoeias and standards including USP, EP, BP, and JP.
CGMP Compliant Services
Our Release Testing covers the required parameters to establish the identity, strength, purity, related substances, impurities, and physical properties under strict CGMP compliance. Testing is performed against specifications and completed promptly.
On-Time Report Delivery
We value deadlines just as much as you do. As a result, we deliver release testing reports on schedule and with the highest level of accuracy.
Industry-leading Release Testing
SK biotek Ireland Analytical Services offers a full suite of analytical techniques to support drug substance Release Testing. Our ability to deliver the best value to our clients is made possible by our extensive knowledge and proficiency in product release testing.
We offer services ranging from the most fundamental tests to the most specialised ones, and we customise our release testing programmes to client requirements. Furthermore, we provide an all-rounded Quality Assurance experience that helps you adhere to safety and regulatory standards.
Join hands with SK biotek Ireland Analytical Services and easily facilitate your drug substance testing.
