The expanding role for X-ray powder diffraction in the pharmaceutical industry.

As counterfeiters become more cunning and technologically advanced, spotting their handiwork is increasingly difficult. Can surface analysis techniques be used to outwit them?

There are two ways in which 'difficult' samples are usually categorized: either by the problems posed by the physical nature of the post-vivo sample matrix containing the chemical entity to be analysed, or...

Our company is involved in developing and manufacturing APIs that can be utilized with drug-eluting stents (DES). Despite ensuring constancy in pharmaceutical composition, we are experiencing issues with variations in drug release during in vitro studies. We are working closely with a stent manufacturer to develop the system, but could surface analysis techniques investigate the problem further?

We are currently experiencing a problem with one of our tablet lines. While the tablets appear white immediately after manufacture, after a time many of the tablets begin to take on a yellowish appearance. Could this be an issue that surface analysis could help resolve?

The crystalline structure of pharmaceutical solids can sometimes be altered during processing. X-ray powder diffraction and near infrared spectroscopy can be used to determine the amorphous and crystalline content of a model substance. The two techniques' precision, accuracy, detection limit and the speed of analysis are compared.

When the United States Pharmacopeia (USP) announced a delay to the proposed implementation date of July 2007 for General Chapter <467> Residual Solvents, pharmaceutical companies supplying the US market welcomed the interim reprieve. However, meeting the new implementation date will prove challenging as the requirement applies to all existing products covered by the USP and companies must still work hard to prepare for July 2008 when <467> will finally come in.

High-performance liquid chromatography (HPLC) is a powerful tool for the enantioselective separation of chiral drugs. However, the selection of an appropriate chiral stationary phase (CSP) and suitable operating conditions is a bottleneck in method development and a time- and resource-consuming task. Multimodal screening of a small number of CSPs with broad enantiorecognition abilities has been recognized as the best strategy to achieve rapid and reliable separations of chiral compounds. This paper describes the generic screening strategy developed at Johnson & Johnson Pharmaceutical Research and Development to successfully develop enantioselective HPLC methods for chiral molecules of pharmaceutical interest.