Analytical Research Services2021-01-08T15:18:20+00:00

Analytical Research Services

Our Analytical Research and Development Teams, located in Dublin, Ireland and Daejeon, Korea, provide excellent services and comprehensive support to customers for all phases of API development. Our experienced Analysts are knowledgeable in method development and lifecycle validation requirements, ensuring that methodology developed is robust and fit-for-purpose for the relevant stage of API development.

The range of analytical services include analytical method development, validation and transfer. Analytical activities are performed in compliance with GMP and ICH guidelines.
We strive to provide our customers with robust analytical methodology but pride ourselves on providing innovative alternatives.

Key Analytical Services

SK biotek offers a wide range of spectroscopic and chromatographic techniques for structural elucidation and characterization of impurities and compound of interest, which will provide our customer with critical information to aid their process development. Techniques readily available at SK biotek include Infra-red, Mass Spectrometry, Nuclear Magnetic Resonance and Ultra-violet/Visible.
With powerful elucidation tools, the Analytical Development Chemist works with the Process Development Chemist to incorporate impurity elucidation into the developed process monitoring methods. This information will form the basis of fate and tolerance information required by the customer during process development.
We are committed to provide our customers with well-characterised reference standard and impurity standards/markers throughout the lifecycle of drug manufacture.
With extensive knowledge and experience, the Analytical Development Chemist works with the Process Development Chemist to identify both potential and known genotoxic impurities that might be present in the product. They are controlled by not only evaluating the risk assessment based on ICH M7 but also meeting regulatory specifications by the proper method with LC-MS/MS.
Building on years of expertise, the Analytical Research and Development Teams at SK biotek offer a fast and efficient validation service and ensure method qualification/implementation is conducted to the highest standard.  Each method is validated to the appropriate regulatory status dependent on the phase of the API life cycle.
To support clinical and commercial stability and to demonstrate robustness and specificity of analytical methodology, SK biotek can perform stress testing and forced degradation studies including photostability.

Analytical cleaning validation is developed and validated in-house utilising different surfaces (glass, Teflon, hastelloy and stainless steel).  Analytical cleaning validation performed is appropriate for the level of manufacture (GMP vs non-GMP, Clinical vs Commercial)

Stability of API, intermediates and starting materials can be performed at a number of different stability conditions in accordance with ICH. Stability chambers are maintained at -20°C, 2°C – 8°C, 25°C/60% RH, 30°C/65% RH and 40°C/75% RH.
• Environmental monitoring of classified areas
• Microbiological Testing (Total Microbial count and bacterial endotoxin) and chemical analysis of water
• Water system validation
• Microbial enumeration testing
• Microbial method validation
• Bacterial endotoxin testing on product
• Chromatography: HPLC (UV, DAD, CAD), UHPLC (UV, DAD, CAD, MS), GC (FID), GC-HS, GC-MS, LC-MS and LC-MS/MS
• Spectroscopy: FT-IR, FT-NIR, Raman, UV-Vis, ICP-OES, ICP-MS with microwave digestion and NMR
• Physical property characterization: Particle size analysis, SEM, PXRD, Particle morphology, solid state characterization using an FT4
• Wet Chemistry: KF, Potentiometric Titration,  Polarimetry


Process Development & Small Scale Manufacturing

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