Element provides comprehensive drug product impurity testing solutions to ICH guidelines for impurities in drug substances and drug products, including ICH Q3A and Q3B, as well as FDA impurity guidance, USP <1086> and USP <476>. Identify and control impurities in pharmaceutical products and biologics with our GMP impurity testing services.
The determination of unwanted compounds in pharmaceuticals is critical to addressing the safety, quality, and purity of drug substances and finished products. Impurities can affect the safety and efficacy of pharmaceuticals and biologic drugs, resulting in the potential recall of marketed drugs or the extension of drug development timelines, as these unwanted chemicals remain with the drug formulation or active pharmaceutical ingredient (API). Impurities can be introduced from a variety of sources, from API and/or excipient degradation, to manufacturing processes, including process impurities, process aids and residual solvents, or from container-closure contact and storage. International Council for Harmonization (ICH) Q3A – Q3E guidance outlines five primary categories for impurities associated with pharmaceuticals, which consist of impurities in new drug substances, impurities in new drug products, residual solvents, elemental impurities, and extractables and leachables (E&L). 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.
Element’s comprehensive impurity analysis and characterization services include impurity identification and quantification, structure elucidation and quantitative determination of impurities and degradation products in bulk materials and biopharmaceutical formulations. Our teams of experienced scientists can isolate and characterize impurities in accordance with US Food and Drug Administration (FDA) and ICH impurity guidelines, including USP <1086> Impurities in Drug Substances and Drug Products and USP <476> Organic Impurities in Drug Substances and Drug Products, and have decades of experience developing and validating methods for monitoring impurities in drugs and raw materials. Our blend of scientific and regulatory expertise, along with a complete suite of advanced instrumentation, enable the accurate and swift identification of unknown impurities, degradants, extractables, and/or chemical contaminants. With extensive experience in developing and validating analytical methodology in a wide range of matrices, our consultative experts can tailor an impurity testing strategy to support the acceleration of your drug development program. Talk to an expert today to explore Element’s pharmaceutical unknown identification and impurity testing services.
USP & ICH impurity profile services
Residual solvents – When solvents used in the manufacture of drug substances or excipients, or in the production of drug substances, are not completely removed by manufacturing techniques, the remaining organic volatile chemicals are referred to as residual solvents. Residual solvents can present a risk to patient safety, depending on their toxicity and concentration. Element’s highly skilled scientists have years of experience testing for residual solvents in pharmaceuticals to ICH Q3C guidelines for residual solvents as well as to USP <467> monograph for residual solvents.
Elemental analysis and elemental impurities – As of January 1, 2018, the FDA requires all new and existing drugs undergo elemental impurities testing to USP <232>/<233>, which has been globally harmonized with ICH Q3D guidance. The control of elemental impurities in pharmaceuticals and biologic drugs is critical to ensuring safe and efficacious drugs are brought to market quickly. Element’s consultative regulatory and scientific experts have deep experience and expertise applying the risk-based approach for the evaluation and control of elemental impurities detailed within USP <232>/<233> and ICH Q3D. We are the elemental impurities testing lab of choice for leading organizations, given our proven track record of developing and validating custom, specific elemental impurities methods and protocols for challenging APIs and complex sample matrices with trace level detection, including those with poor solubility.
Trace metal impurities – Element offers a comprehensive suite of trace metal impurities testing services, including metals speciation analysis. Our dedicated, knowledgeable scientists have deep expertise in detecting, identifying, and quantifying trace metal impurities in a wide variety of samples, including pharmaceuticals, biologics, drug substances, drug products, medical devices, raw materials, finished products, and more. Beyond testing to regulatory guidance and applicable USP general chapters and monographs, our experts can develop and validate robust analytical methods for qualitative and quantitative limits testing of specific elements and metals.
Process impurities and residuals in biologics – Element offers custom analytical method development and validation for the identification and quantification of product impurities and process residuals in biologic drug products per ICH Q6B specifications. Our consultative, dedicated scientists have considerable expertise in the characterization of product-related impurities and control of impurities in biologics, including cell substrate-derived process impurities, cell culture-derived impurities, and downstream-derived impurities.
Organic impurity identification and quantification – Organic impurities in APIs and drug formulations can arise during manufacturing or storage, and can come from a variety of sources, including starting materials, intermediates, byproducts, reagents, ligands, catalysts, and degradation products. Element’s organic impurity identification services provide valuable data throughout drug development, from identifying impurities formed during synthesis to assessing degradation products observed during stability.
Structure elucidation – Unknown peaks can result in costly delays, resulting in a need for rapid and effective investigational analyses to characterize unidentified peaks. Stress conditions can be replicated in our laboratories to replicate impurity peaks, and Element’s highly skilled scientists have a proven track record of accomplishing structural elucidation of unknown peaks in pharmaceuticals. With a variety of advanced analytical instrumentation and techniques available, we have the resources, experience, and expertise to successfully investigate and identify unknown peaks.
Extractables and leachables studies (E&L) – Potentially harmful organic and inorganic impurities can migrate into finished products from container-closure systems, manufacturing components, process equipment, packaging or delivery devices, altering product efficacy and/or safety. Element has one of the largest and most experienced extractables and leachables (E&L) practices in the world. Our industry-leading, comprehensive E&L services have been built upon a foundation of in-depth knowledge of regulatory guidance, materials science, and advanced equipment.
Forced degradation studies and degradation products – Forced degradation studies provide valuable information regarding the stability of a drug substance. These stress studies of drug molecules are used to determine its intrinsic stability characteristics and enable the identification of degradation impurities and degradation products. In addition to studies in alignment with ICH Q1A guidance, Element also offers custom method development and validation, qualitative and quantitative analysis, and tracking and trending of stability study data.
The Element advantage
Not only is the identification of contaminants critical when developing new products, but it is also essential in verifying the safety of finished products. Ensure the safety, quality and efficacy of pharmaceuticals with Element’s comprehensive impurity analysis and characterization solutions, which include wrap-around services such as reference standard characterization and management, stability programs, and analytical investigational services. Our consultative teams of scientists are well-versed in FDA and ICH regulatory guidance and have decades of practical experience in pharmaceutical impurity identification analysis.
To learn more about Element’s flexible and customized solutions for biopharmaceutical and pharmaceutical impurity testing, from characterization to identification of the source of the impurity, or to speak with one of our experts, contact us today.
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