Reference Standard Qualification
SK biotek Ireland Analytical Services offer CGMP qualification and characterisation services to establish the identity and potency of Primary Reference Standards (PRS).
Extensive Reference Standard Qualification
SK biotek Ireland Analytical Services offer initial characterisation, certification, expiry dating, periodic requalification, storage, and distribution to support customer reference standard material programmes.
Our Reference Standard Qualification Techniques Include:
- Fourier Transform Infrared Spectroscopy (FTIR)
- Nuclear Magnetic Resonance (NMR)
• 1H NMR (one and two-dimensional)
• 13C NMR
• 31P NMR
• 19F NMR
- Ultra Violet Spectroscopy (UV)
- X-ray Powder Diffraction (XRPD)
- Differential Scanning Calorimetry (DSC)
- Thermogravimetric Analysis (TGA)
- ICP-MS and ICP-OES for Elemental Impurities and Composition Analysis
- Non-Combustible Impurity Analysis by Residue on Ignition
- Optical Rotation
- Particle Size Distribution (Wet and Dry)
- Liquid Chromatography (UHPLC/HPLC)
- Gas Chromatography (GC-MS/GC-FID)
- Ion Chromatography (IC)
- Mass Spectrometry (MS)
• Including hyphenated techniques LC-MS and GC-MS
• Exact mass, high-resolution LC-MS is also available
- Water Content by Karl Fischer Titration including KF Oven (Coulometric and Volumetric)
- Appearance, by visual inspection.
The SK biotek Ireland Analytical Services Advantage
Alongside fully cGMP labs and facilities that maintain Quality and Health & Safety track records, SK biotek Ireland Analytical Services strives to always produce accurate results.
60 Years of Trust
With 60 years of expertise, we guarantee compliance with regulatory requirements, qualifications, and management plans tailored to your specific needs.
We offer custom synthesis, purification and certification of reference standards and authentic material. We can provide this service for novel raw materials, intermediates and active pharmaceutical ingredients as well.
Storage, Logistics & Traceability
We take pride in our structured logistical support to store, ship and track the reference materials.
Secure ICH Shipping & Storage
Our Reference Standards are available for global export under appropriate temperature and security conditions ensuring our customers have sufficient and substantial reference standard quantities.
SK biotek Ireland Analytical Services CGMP compliant facilities are equipped with top-of-the-range technology to deliver validated data for determining the potency to aid releasing future batches of material with reliable consistency.
By offering value-added support, we allow our clients to cut costs on expensive instrumentation. We offer clients the flexibility to select the equipment and the level of support they need.
From receipt of the initial enquiry, SK biotek Ireland Analytical Services ensure to curate and methodically address client demands. The requirements of the Reference Standard Material program are always aligned with the client’s needs.
Regulation Compliant Innovations
Our strict protocols and thorough analyses ensure accurate results while meeting all regulatory requirements. A Certificate of Analysis (COA) is delivered with all our Reference Standards.
Credibility That Fosters Trust
SK biotek Ireland Analytical Services work closely with clients to establish the requirements of their Reference Standard material programs. Our expertise promotes trust—you can rely upon our support to store, ship, and track your reference materials.
With us, reference standard materials are stored in secure locations and monitored continually using a qualified environmental monitoring system. Our Reference Standard management program ensures that sufficient Reference Standard quantities, held at the correct conditions, are available for controlled distribution worldwide.
With SK biotek Ireland Analytical Services, you gain a partnership that puts your needs on top.