Impurity isolation and characterization is a broad area of analytical services integral to the development process for drugs or pharmaceutical products to ensure drug safety, efficacy, and compliance with regulatory requirements. With such crucial roles, it’s imperative that clients are given the most accurate, in-depth characterization results, a process in which Olon USA excels. Read on to learn more about how Olon USA goes above and beyond to ensure client satisfaction throughout the impurity identification and characterization process.

Good products must be well-defined

Good drugs or other pharmaceutical products must have well-defined purities and molecular structures to succeed and make it to market. As such, the discovery of an impurity in a product can quickly derail a project, and clients must devote valuable time and resources to resolve the challenges presented by these discoveries, whether that be removing the impurities from their formulation, or in the case of benign molecules, increasing their acceptance rates. Questions regarding toxicity, including whether the impurity may be carcinogenic or genotoxic, of the impurity must be addressed before the development of the product can proceed to meet FDA and other regulatory agency requirements.

Mastering Impurity Analysis to Produce Superior Results

Often, impurities are first noticed during routine characterization analyses such as Nuclear Magnetic Resonance (NMR) or high-performance liquid chromatography (HPLC); once discovered, they must be further identified. These impurities will sometimes present as small peaks in generated chromatography data, and might only compose a miniscule fraction of the compound, sometimes over a thousand times less than the main drug components. Following its discovery, the impurity must be located, identified, and isolated so that initial characterization based on molecule structure can be performed. Initial characterization is then followed by the application of more in-depth methods including multidimensional nuclear magnetic resonance (NMR), single crystal X-ray diffraction (SCXRD), infrared spectroscopy (IR) and mass spectrometry (MS) to elucidate the molecular structure. Detailed structural characterization of impurities is necessary to support the generation of reference standards, the development and validation of analytical methods, drug release GMP testing, and toxicology or bioequivalence studies.

Olon USA’s expertise allows them to take impurities discovered in a client’s product and do the detective work necessary to accurately identify and thoroughly characterize it to ensure the client’s successful product development.

Finding the Right Tool For The Job

Every molecule is different and therefore requires an individualized approach for its identification and characterization. Olon USA can tailor their services to each individual molecule, providing clients with a customized approach. Molecules may require combinations of different separation techniques and spectroscopic techniques to resolve their complex structures, but Olon USA has found that oftentimes the most difficult projects simply require the right tool for the job. Olon USA is able to employ a variety of tools to ensure complete characterization of molecules for their clients, no matter how challenging the molecule may be.

Flexible Science for High-Quality Results

While many large companies have the capability to provide analytical services, including impurity isolation and characterization, it takes a nuanced approach to be successful in these endeavors. Olon USA understands the nuance necessary to deliver successful results and prides itself on its broad scope of knowledge that aids in its continued success. The scientists at Olon USA are not only highly knowledgeable in their fields, but they’re willing to continuously evolve their techniques to optimize results for unique molecules, and they have the experience needed to select the best methodology from the dozens of available techniques.

Olon USA Works With Clients to Find Their Needle in the Haystack       

Clients have consistently expressed their satisfaction with the services provided by Olon USA, due to their extensive knowledge not only in the analytical chemistry space but also in the project management space, including their ability to provide results in a well-illustrated presentations and data package that allows customers to truly understand all of the science and data involved. When dealing with impurities, clients are often faced with a search much like trying to find a needle in a haystack, and Olon USA aims to simplify that search through their commitment to excellence.

Combining Science and Art for Complex Analyses

Olon USA has the capability to start from complex analytical methods. Clients can bring in complex chromatograms, with challenging separations because the chromatographic behavior of the molecules are so structurally similar. Olon USA can translate these challenging results from the analytical level to a preparative or macro level for the isolation of tangible, usable amounts of material. Ultimately, these molecules, observed as analytical signals, must be converted into multi-milligram, or multi-gram quantities of suitable purity that can be used for further analyses and development. In order to do that the analytical method needs to be translated to the preparative, much larger scale. This translation is often difficult and requires a degree of artistry to get right. In that context, Olon USA has extensive knowledge of chromatographic separation techniques such as reversed phase, normal phase, ion exchange, etc., coupled to a diversity of detection techniques, ultraviolet (UV), mass spectrometry (MS), charge aerosol detection (CAD), evaporative light-scattering detector (ELSD), and refractive index (RI). The development and implementation of chromatographic purification is supplemented by a powerful analytical toolbox intricately connected to a strong understanding of the organic chemistry and structural nature of the molecule being studied.

Driven to Ensuring Purity

Once an impurity is identified, Olon USA drives itself to produce highly pure material to ensure any gathered data is highly specific and selective. The process of trying to produce large amounts of material for testing is often complicated, and thus it can be difficult to produce materials to a high standard of purity, which results in the generation of complicated data that isn’t conclusive. Olon USA is able to resolve these purity issues and ensures clients can trust the data they’re delivered.

Highly Sophisticated Structural Elucidation

While other companies can provide structural characterization of molecules, Olon USA goes above and beyond. They can handle the structural elucidation of molecules at the highest level of sophistication by using advanced NMR techniques, bi-dimensional spectroscopy, high resolution mass spectrometry, and other methods that make their results stand out.

Minimizing Downtime and Productivity Loss

The discovery of an impurity in a product results in a complete halt of operations, causing an immense loss of productivity for clients. As such, it is imperative that once impurities are discovered, they are identified and characterized as quickly as possible in order to minimize the financial loss for the client and get their operations going again.

Olon USA excels in its ability to provide excellent project management so that turnaround time for services is minimized. They identify steps in the isolation and characterization process that can be performed in parallel, to maximize project efficiency and reduce time spent waiting on results. This allows them to provide turnaround in as little as 6 weeks for highly challenging molecules, helping clients meet their goals and get their projects back on track.

Contact Olon USA to Learn More: Prospective clients in need of impurity identification and characterization are invited to reach out to Olon USA today to discover how they can tailor an approach to provide the perfect fit for your needs.