It’s been four years since the International Conference on Harmonization adopted ICH Q3B(R2), which harmonizes the content and qualification of impurities in drug substances, including extractables and leachables (E&L) produced by the interaction of a drug substance and its container-closure system. And yet, there still seem to be a huge amount of questions surrounding these degradation byproducts, stability testing, thresholds, and reporting requirements.

Read more »

Last week’s McDonalds glassware recall is another example of the problem of heavy metals appearing in consumer products. The fast-food giant, in cooperation with the Consumer Product Safety Commission (CPSC), recalled its promotional Shrek glassware because of the elevated level of cadmium found in the glasses. Read more »

Research and development (R&D) scientists may have been feeling down in the dumps lately. Many of them have lost their jobs in the last few months as a result of mergers and cost-cutting projects. But these sometimes underappreciated workers may soon get more respect, thanks to a US government initiative. Read more »

As if the US community isn’t already paranoid enough about the H1N1 swine flu virus and its vaccine, this week, Sanofi Pasteur, the vaccines division of the sanofi-aventis Group in France, recalled 800,000 prefilled vaccines.

Read more »

Reading the news sometimes gives me a disorienting sense of déjà vu. I felt it again when I read that Ranbaxy (Gurgaon, Haryana, India) had recalled a batch of its acne drug isotretinoin after the US Food and Drug Administration found that the product’s dissolution-test results were out of specification. Didn’t this happen once before? Read more »

In the latest news regarding the US Pharmacopeia’s proposed limits and test changes for heavy metals, the organization is expected to post new information on its website regarding its plans to revise General Chapter <231> based on its June 2–3 USP PNP stakeholders meeting. Read more »

Ever since USP released its stimuli article last fall regarding the new, pending General Chapter <231> on Heavy Metals, industry has been up in arms about the proposed changes. Pharmaceutical manufacturers are uncertain of how they are going to move from purely wet-chemistry methods to more complicated, not to mention more expensive, methods such as inductively coupled plasma-mass spectrometry (ICP-MS), graphite furnace-atomic absorption spectrometry (GF-AAS), and cold vapor AAS to test their products for metal impurities. Read more »

Perhaps out of embarrassment at the stream of incidents involving contaminated products, the US Food and Drug Administration has requested the largest budget increase in its history. The agency intends to use part of the funds for its proposed Safer Medical Products initiative, which will scrutinize domestic and imported drugs. Will it use the money wisely? Read more »

As an editor for Pharmaceutical Technology, I often hear about novel drug-delivery mechanisms. Often they’re high-tech materials such as polymers, hydrogels, or nanoparticles. But a recent Associated Press story revealed a biological-based drug carrier that I hadn’t thought of: fish. Read more »

Pharmaceutical Technology magazine presents part two of its vidcast program, recorded at INTERPHEX 2009. Click the links below to watch the vidcasts. (Click here to see day one of the vidcast program.) Read more »