Determination of unwanted compounds in pharmaceuticals is critical to addressing the safety, quality, and purity of drug substances and finished products. That’s why Element strives to provide absolute testing certainty by delivering pharmaceutical unknown identification and impurity testing of both organic and inorganic material, supporting method development and product investigations.
Ensuring the safety of a product is a critical aspect of every manufacturing process. Contaminants can be introduced to a drug product at multiple stages in the supply chain, whether during manufacturing, packaging or storage, posing a health hazard to patients if undetected. Accurate and swift identification of unknown impurities, degraded products, extractables or chemical contaminants plays a vital role in bringing a safe and quality product to market. Not only is the identification of contaminants critical when developing new products, but it is also essential in verifying the safety of finished products.
Our Engaged Experts work closely with customers to support them at every stage of their product development, from an early stage and across the lifecycle of the product, to identify unwanted compounds and ensure they are pure, safe, and quality.
Our unknown identification and pharmaceutical impurity testing services including:
- Mass spectroscopy for liquid chromatography, including time of flight accurate mass spectroscopy
- Universal screening with HPLC-PDA/CAD/MS
- Headspace GC-FID, GC-MS, and Wiley Mass Spectral Library
- Preparative-scale HPLC with fraction collection capability and cGMP compliant 500 MHz NMR
- Simultaneous and sequential instruments for trace metals analysis by ICPMS, ICMS
- Micro-Fourier Transform Infrared (Micro-FTIR) Spectroscopy with microscopic attachment
- Scanning Electron Microscopy (SEM) coupled with Energy Dispersive X-Ray Spectroscopy (EDS) for identification of inorganic components
Working with Element
With advanced analytical instrumentation and extensive expertise, Element is your trusted testing partner for identification of both organic and inorganic materials. Our scientists have a proud history providing pharmaceutical impurity testing and contaminant analysis, from residual solvents to extractables and leachables and degradant related issues. Our breadth of capabilities also enables us to provide support to forensic investigations as well as independent expert witness services.
To learn more about our pharmaceutical impurity testing and contaminant analysis, contact us today.
More from Element
Extractables and Leachables Studies
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
Elemental Impurity Testing and Analysis
Element’s trace metal laboratories provide expert elemental impurities testing and analysis in compliance with USP and ICH Q3D guidelines to ensure the safety of drugs and drug products.
Pharmaceutical Method Development and Research
Element provides a full suite of pharmaceutical method development and research services to bring your products to market at optimal speed.
Learn more about our laboratories - where they are located; the unique capabilities they have and how they can help you solve your technical and commercial challenges.