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Elemental impurities, such as arsenic, cadmium, lead and mercury are ubiquitous in nature. They are also toxic to humans and animals at certain levels. Because these elements are often part of mined minerals used in the manufacture of drug products and/or drug containment systems, they can have an impact on the quality of a drug.
New USP standards recently became mandatory for measuring elemental impurities in pharmaceuticals and their ingredients. The new USP General Chapters, USP <232> (Elemental Impurities – Limits) and USP <233> (Elemental Impurities – Procedures), have replaced USP <231> (Heavy Metals). USP <231>, which has historically been used to test for heavy metals in drug products as well as packaging components, has been withdrawn.
While USP <232> does not directly apply to animal drug products, the Center for Veterinary Medicine (CVM) expects sponsors of animal drug products to continue to apply a risk-based control strategy for elemental impurities and establish appropriate acceptance criteria and test methods for elemental impurities where necessary.
To aide our pharmaceutical partners invested in animal health, West performed an analysis of our top 25 elastomeric formulations. This information can be found on West’s Technical Bulletin, located along with a plethora of other information in West’s Knowledge Center. West’s Knowledge Center provides additional scientific insight and more detailed technical information. Our Technical Customer Services (TCS) representatives are available to offer additional support to customers seeking information.
Visit West’s Knowledge Center here to learn more!
Recently, there has been increased scrutiny from regulatory authorities to quantify and qualify subvisible particles in biopharmaceutical products. Such particles, which can cause a protein to denature, are of concern to pharmaceutical manufacturers since they can affect the efficacy of the drug product. As regulatory bodies continue to raise the bar on quality, industry is looking for “zero defect” and particle free components as well as a way to minimize quality variation.
In its 95+ year history, West has developed and marketed a very large number of elastomeric formulations, each designed to address particular market demands. Over this time, various aspects of drug product quality have gained attention – a fact reflected in the numerous regulatory guidances that have been issued. An early focus of these guidances was extractables and leachables, followed closely by particulate matter and container closure integrity. Beyond these regulatory requirements, the market demands product portfolios that enable platforming and predictable, consistent product quality and performance.
<em>West is pleased to welcome guest blogger Katrina Firlik, MD, Chief Medical Officer and Co-Founder of </em><a href="https://healthprize.com/"><span style="text-decoration: underline;"><em>HealthPrize Technologies</em></span></a><em>. This is the second installment in a series on the West/HealthPrize collaboration.</em>
West is committed to the safe and efficient delivery of drug products to patients. An important aspect of this commitment is engagement in standards-setting organizations; West is a member of the European Pharmacopeia Commission, Group of Experts 16 – who contributed to European Pharmacopoeia 9.5 (effective July 2018).<br /><div> </div>
Where science and technology are evolving quickly, a good networking structure is needed to keep pace of advancements. This is especially relevant for regulatory agencies in the pharmaceutical field. EMA recognizes this and addresses it with the strategic plan: Regulatory Science to 2025 – focused on quality, safety and efficacy of both human and veterinary medicines. The draft of this plan, which was created by the Member States and the European Commission, and comprised input from two workshops with stakeholders, was published in December 2018 for a six-month public consultation.
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