6 Oct 2022

Impurity Identification and Control Strategy for API Development

A critical component of API process development is achieving a full understanding of the impurity profile while establishing a control strategy. Impurities can be introduced into an API at many stages in the process including through raw materials, product reactions, workup degradation, and isolation conditions.

The ability to identify the origin of the various impurities, understanding their fate, and ultimately how they are purged from the final API are areas in which Grace’s Fine Chemical Manufacturing Services (FCMS) team has extensive expertise. Join our Learning Lab at CPHI Frankfurt to understand how a regimented impurity control strategy guided by research best practices and extensive knowledge of regulatory expectations are critical in API development.

Click here to register

Content provided by our supplier

W. R. Grace & Co

  • US
  • 2015
    On CPHI since
  • 1000 - 4999
Company types

Other Content from W. R. Grace & Co (12)

  • News Grace Completes Acquisition of Fine Chemistry Business

    June 01, 2021: W. R. Grace & Co. announced the completion of its acquisition of the Fine Chemistry Services business (“FCS”) of Albemarle Corporation (NYSE: ALB) for approximately $570 million, including $300 million paid in cash and $270 million funded through the issuance to Albemarle of non-participating preferred equity of a newly created Grace subsidiary.
  • Brochure Grace Pharmaceutical Solutions Brochure

    Learn more about Grace's unmatched quality and reproducibility of our fine chemicals, chromatography resins, formulation excipients, and active ingredient delivery technologies.
  • Brochure SILSOL® Silica-based Drug Delivery Technology Sales Sheet

    SILSOL® silica was engineered to bring together advanced silica technologies with challenging active pharmaceutical ingredients (APIs) to effectively formulate a large class of poorly soluble but otherwise promising compounds. Download the sell sheet to learn more.
  • Brochure Grace Fine Chemical Manufacturing Services (FCMS) R&D From Concept to Commercial

    Grace Fine Chemical Manufacturing Services (FCMS) has the facilities and expertise to support product development at every stage, from contract research through commercial manufacturing. Having the appropriate resources where you need them, when you need them is critical, and our multiple locations vicand deep experience can help ensure your success.
  • Brochure Converting Oily Liquids into Powders and Liquisolids Delivery

    Grace’s SYLOID® XDP mesoporous silica gels are designed to haveoptimized oil absorption properties, oil desorption rate and density.Thus, oily actives and SEDDS (Self Emulsifying Drug Delivery Systems)can easily be processed into a free-flowing powder that can be furtherformulated into several oral solid dosage forms (OSDF) like powders,tablets and hard gelatin capsules. These powder dosage formulations canpotentially improve stability, bioavailability and patient compliance.
  • Brochure DAVISIL® Chromatographic Silica Solutions

    Discover how DAVISIL® chromatographic silica can provide improved performance, predictable scale-up, exceptional product reliability and provides a greater selection.
  • Brochure Grace Nutraceutical Solutions Brochure

    How much faster could you achieve commercialization by using pharmaceutical-grade products that can be tailored to your specifications to overcome challenges unique to nutraceutical and dietary supplement formulations? Imagine what you could make possible with Grace's Nutraceutical Solutions. Learn more about Grace's Nutraceutical Solutions at
  • Brochure Grace Silica Technologies for COVID-19 Diagnostic Kits, Vaccine Purification, and Drug Formulations

    Learn how Grace's silica gel portfolio can be included in diagnostic kits, vaccine purification, and tablet and capsule formulations.
  • Video Natural Extracts: Unlocking the Potential of Cannabinoid Derived Drugs

    Originally aired during the CPHI Festival of Pharma 2020, this webinar examines the current landscape for cannabinoid derived drugs, including looking at pipeline and approvals, development challenges and regulatory hurdles.
  • Video Driving Excipient Innovation

    This session was originally broadcast as part of the CPHI Worldwide 2021 digital content programme. All parties of the pharma supply chain – from manufacturers to patients – want to see the commercialization of innovative products that advance therapeutic treatments. While innovation in the industry remains at the forefront, when it applies to final drug products or boosting API potency, an often-overlooked element is excipients. Excipients play a crucial role in enabling products to achieve desired performance. New ways of delivering, applying, and manufacturing drug compounds are rising thanks to novel excipients. Patients benefit from improved compliance, alternative routes of delivery, upgraded safety profiles, and advancements that are overcoming unmet medical needs. Grace’s broad range of novel excipients accelerate compliance and enhance bioavailability, solubility, and moisture protection. Discover how we are solving many of today’s challenges in drug delivery and formulation.
  • Video Grace SYLOID®️ Silica Excipients for Pharmaceutical and Nutraceutical Solutions

    race’s SYLOID®️ FP and SYLOID®️ XDP silica excipients are strategic drug development tools in today’s challenging pharmaceutical industry with its demands for improved formulations, bringing new drugs to market faster, and technological advances. Learn more about Grace's SYLOID®️ Silica Excipients for Pharmaceutical and Nutraceutical Solutions at
  • Video Grace DAVISIL®️ Chromatographic Silica for Pharmaceutical and Nutraceutical Solutions

    Imagine what you could do with chromatography products that deliver specificity, recovery, reproducibility,and superior efficiency for the very demanding challenge of separating and purifying unique biological compounds. Learn more about Grace's DAVISIL®️ Chromatographic Silica for Pharmaceutical and Nutraceutical Solutions at