First introduced over 100 years ago, USP<231> is a colorimetric procedure based on the precipitation of insoluble metal sulfides. This test for heavy metals is qualitative rather than quantitative. It is not an element specific method, nor is it equally sensitive to each metal. The limits specified by the test are based on the ability to observe the precipitate, rather than on the analysis of toxicological data. The procedure does not necessarily detect all potential forms and/or valences of elements of concern when they are present as the oxo ions or in the organometallic form. Chromium and nickel are potential contaminants from modern stainless steel processing equipment and are not detected by the USP<231> test method. Other studies indicate inconsistent recoveries of monitor and standard solutions using USP<231> method II.2, 3
Throughout 2011, we have been talking to customers about what their testing needs are, what has worked for them, what hasn't worked in 2011 and strategizing about how this will impact their laboratory testing plans for 2012. This includes reviewing our blog to make sure we understand which articles had resonated the most with our website visitors.
Lately, there seems to be more and more discussion about how does the pharmaceutical industry fix R&D. It's no secret the industry is suffering and innovation seems to be lacking. Stock prices of the large pharma companies are down 40%, 300,000 jobs have been lost in the last ten years and new drug approvals have slowed immensely.
Join us on the new LinkedIn Laboratory Research & Testing group. This group has been created to learn and share and help you develop new, R&D intensive analytical and bioanalytical approaches to expedite the process of bringing new products to market. We aspire to create an environment where the brightest academic ideas can be efficiently integrated into a highly regulated drug development framework.
Over the last decade, biotech antibodies have provided some of the biggest breakthroughs in medicine. The list includes: Avastin, Herceptin, Rituxan and Erbitux for cancer; Enbrel, Humira, and Remicade for immune and inflammatory disorders.
The European Medicines Agency is planning to adopt stricter guidelines on test method validation for technical transfers to CMO's. These revisions to Chapter 6 Quality Control, EU Gudilines to GMP were published in September and the EMA is requesting comments to be submitted to it by February 2011. "Outsourcing-Pharma.com" has a piece about it that you can read here.
Like most analytical CRO's, Diteba relies upon their High Performance Liquid Chromatography (HPLC) systems as being the workhorse of the laboratory. From assay and purity work on raw materials, to stability sample testing, to bioanalytical analyses, the HPLC instruments are often critical to Diteba's and our sponsor's success.
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