Analytical services

Analytical requirements vary across the API lifecycle, but a comprehensive approach at every stage is key to long-term project success.

At Sterling, we deliver extensive analytical chemistry services spanning the entire molecule lifecycle, starting with discovery. Our analytical approach is thorough yet tailored, as we support a full range of analytical methods based on customer requirements and stage of development. From method development and validation to impurity assessments, reference standard management, equipment monitoring and more, our approach to analytical chemistry delivers our customers high-quality, repeatable results to optimise processes and support ongoing compliance.

We provide analytical support as part of our integrated API development and manufacturing services, as well as a standalone service offering.

Explore our analytical services below:

Impurities have critical implications for product quality and efficacy, as well as compliance. We apply techniques including nuclear magnetic resonance (NMR) spectroscopy, high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS) and more to identify, quantify and characterise impurities. Then, we leverage fate and purge experiments to assess whether impurities are released as waste or carry into the final product.

If a harmful impurity does persist throughout the process, we perform additional impurity assessments to identify the source of the impurity and adjust reaction conditions accordingly.

To accurately determine impurity levels and byproducts, we provide expertise in validated Stability Indicating Methods (SIMs) that align with FDA expectations. Using Stability Indicating Methods throughout stability testing enables us to evaluate and maintain product quality, safety and efficacy over time and under different conditions. Some of the analytical methods we leverage include HPLC, liquid chromatography mass spectrometry (LC-MS), gas chromatography (GC) and more.

We perform thorough stability testing to assess if and how an API’s properties change over time. To do so, we decide on environmental conditions and monitor changes using Stability Indicating Methods. We take care to evaluate both physical and chemical changes to advise on an appropriate shelf life and define proper storage conditions.

Potential genotoxic impurities (PGIs) can surface at different stages of development, and their carcinogenic properties make them critical to remove from an end product. We conduct PGI assessments marked by high specificity and selectivity in alignment with ICH M7 guidance. HPLC or UHPLC with UV detection, gas chromatography and mass spectrometry are central to our PGI assessment strategy.

Across our global facilities, we have a range of specialised analytical equipment to support a variety of project requirements, from research and development to quality control. Across our global facilities, our analytical equipment and capabilities include:

• HPLC and UHPLC, detectors including DAD, ELSD, CAD, fluorescence, and MS
• Gas chromatography and GCMS
• 200 MHz and 500 MHz Varian multinuclear NMRs
• GCMS and LCMS for low-level detection
• Flash chromatography mg to hundred-gram scale
• FTIR Including ATR
• Karl Fischer/loss on drying for water content
• Metrohm automatic titrator
• UV-vis spectrophotometer
• And more

If you’re interested in a specific analytical chemistry service, contact us to learn more.

To ensure ongoing product stability and assess behaviour under different stress conditions, we carry out thorough forced degradation studies. These studies help us to understand degradation pathways and rates, as well as inform the development of Stability Indicating Methods. Forced degradation studies are another critical step in affirming quality and stability of the final API.