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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, which has historically been used to test for heavy metals in drug products as well as packaging components, has been withdrawn.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!
West turns 100 this year! A milestone we are very proud of, and something few companies have the opportunity to celebrate. Today, we are a global market leader who is defining the evolution of our industry. AND that’s the way West has operated since the beginning.
With the prevalence of Non-alcoholic Steatohepatitis (NASH) rapidly increasing globally, West is working with its pharmaceutical partners to support their development of new injectable treatments for this serious liver condition. However, there are many challenges associated with trying to bring new treatments to market.<br />
I am the Head of Procurement for Civica, one of West’s customers. <br />Civica is working to solve two big problems in U.S. healthcare - drug shortages and predatory pricing. Our mission is to ensure quality generic and biosimilar medications are available and affordable to everyone.
Imagine self-administered cancer treatments in the comfort of a patient’s home. How close are we to making this a reality? During this unprecedented time, immuno-compromised patients can benefit from receiving a self-administered, home-based treatment option. One major factor into making home-based cancer treatment a reality is a focus on shifting the route of administration from intravenous to subcutaneous delivery. Due to an emphasis on patient involvement in shared decision making for health care policy and medical approaches, understanding the intravenous to subcutaneous transition in medical injections has garnered increased importance. If therapeutic efficacy is not compromised, the less invasive nature and convenience of subcutaneous injections is often the preferred route of administration.<sup>1-2,4-6</sup>
When selecting parenteral packaging components, the vial and stopper are typically discussed, but the seal is often an afterthought. Seals do not have direct product contact and are considered secondary packaging. However, the selection of an appropriate seal is critical to assure proper container closure integrity as well as determine how the product will function for the end user.
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