Analytical services are essential to ensure your APIs and excipients meet all quality and regulatory requirements. At Evonik Health Care we offer comprehensive analytical services for a broad and diverse range of active pharmaceutical ingredients (APIs) and novel excipients. Our in-house teams of highly specialized staff take care of your project from early-stage development up to commercial production.

As a CDMO we can provide a full package from process development for new and existing APIs, to production and on-site analytical method development. We also carry out validation and in -process controls along the complete product life cycle from early development to clinical phases and commercialization. Our large and global network of experienced analytical scientists enables fast and complex problem solving and the application of diverse technologies. By having technologies on site, our services are faster and more efficient, and you gain deeper insights.

• Direct contact with our analytical department
• 24/7 production support through our In Process Control (IPC) labs
• Special technologies in house

When you need fast solutions to complex challenges, you can rely on our in-house analytical scientists and diverse range of technologies including GC (-MS), HPLC (-MS), NMR, MALDI and many more. Our strong experience and intensive analytic support for regulatory films such as IND, NDA and DMFs, together with our track record of regular audits by authorities (FDA, EMA) and customers, ensure the highest quality control for your pharmaceuticals.

Our analytical activities include method development, transfer and validation, and verification according to applicable guidelines or pharmacopeial requirements such as USP/EP/JP for:

• Raw materials
• In-process control
• Intermediates
• Final APIs and HPAPIs
• Excipients according to ICH and GMP guidelines

We also provide stability studies according to ICH guidelines at different conditions: (-20°C up to 40°C/75% relative humidity).

And we offer further activities including:

• Cleaning Validation
• Qualification and characterization of reference standards
• Impurity profiling and identification
• Structural elucidation
• Forced degradation studies
• Method development for mutagenic toxicities according to ICH M7  

• KF-Water determination: volumetric, coulometric, oven
• Titration: acidimetric, alkalimetric, complexometric, redox, precipitation, reaction, non-aqueous
• Spectroscopy: absorbance, endotoxins, photometric methods, fluorimetry, color number, turbidity
• Digestions: Kjehldahl-Nitrogen, Wickbold for determination of sulfur and halogens, sulphated ash, ROI, heavy metals
• Product specific parameters: pH, optical rotation, conductivity, density, loss on drying, identity, appearance
• Gas chromatography: Headspace samplers, split/splitless (SSL) injection, cool on column injection (COC), purged packed injection (PP), programmable temperature vaporizing (PTV); Flame Ionization Detector (FID), Thermal Conductivity Detector (WLD), Electron Capture Detector (ECD), Nitrogen-Phosphorus Detector (NPD)
• (Ultra) High Performance Liquid Chromatography (HPLC): UV/Vis and DAD-detection, RI- and fluorescence detection, ELSD, CAD

Furthermore, Analytics of Evonik broadens our internal range of techniques:

• Amino Acid Analyzer
• LC-MS, GC-MS
• ICP-MS, ICP-OES
• MALDI-TOF-MS
• NMR, FT-IR, XRPD, Raman
• Electron Microscopy (SEM, TEM)
• And many more…

Are you looking for analytical support along all stages of your product lifecycle? Find out about the benefits of partnering with us – all the support you need from a single source. Get in touch with us.