Impurity Identification and Testing
Alera Labs offers comprehensive impurities testing for both small and large molecule drug products or APIs. We can perform forced degradation studies, which will provide an insight into potential degradation pathways and their potential impact on pharmaceutical development. Degrading related impurities can be characterized or identified by performing degradation studies under acidic, basic, oxidative, and various heat and light conditions. Degradant products can be identified by LC/MS, LC/MS/MS, GC/MS, as well as other techniques.
– Industries: Pharmaceutical Industry, Agbio, Biotechnology, Medical Devices Industry
– Techniques: HPLC, GC-MS, LC-MS, LC-MS/MS, NMR
Alera Labs provides rigorous impurities identification and testing services to industries such as pharmaceuticals, AgBio, biotechnology, and the medical devices industry. Leveraging advanced analytical techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS), Nuclear Magnetic Resonance (NMR) Alera Labs ensures that their clients’ products meet the highest standards of safety, quality, and efficacy.
Identifying and quantifying impurities is a critical aspect of product development and quality control. These impurities, which can be introduced at any stage of the production process, can potentially impact the safety and efficacy of the final product. HPLC, GC-MS, LC-MS, NMR, and LC-MS/MS techniques enable Alera Labs to accurately detect and quantify these impurities, regardless of their source.
In the pharmaceutical industry, impurity testing is crucial in the development and production of drugs. Whether these impurities are residuals from the manufacturing process, degradation products, or contaminants, their identification and quantification is necessary to ensure patient safety, drug efficacy, and regulatory compliance.
For the AgBio industry, impurity testing can be applied to identify and quantify unwanted residues or contaminants in crop protection products, genetically modified organisms, or plant biostimulants. In biotechnology, impurity testing can be employed to ensure the purity and safety of biological products, such as recombinant proteins, vaccines, or antibodies.
In the medical devices industry, impurity testing can be used to detect and quantify contaminants in device materials or coatings, ensuring the safety and performance of the medical device. For instance, it can be used to identify trace metals, residual solvents, or leachables that could potentially compromise the biocompatibility of the device.
In summary, Alera Labs’ impurities identification and testing services, backed by a suite of sophisticated analytical techniques, provide a critical component of quality control for the pharmaceutical, AgBio, biotechnology, and medical devices industries. These services ensure the safety, quality, and efficacy of their products, supporting regulatory compliance and risk management.