Pharmaceutical Analysis

Latest News


BioTek Instruments has appointed Millennium Science as their official distributor in New Zealand. Millennium Science will now be responsible for sales and support of the company?s entire line of microplate-based instrumentation and software in New Zealand and Australia.

Grace Davison has received the 2009 R&D 100 award for its REVELERIS flash chromatography system. Flash chromatography is used in the purification of new entities in the early stages of drug discovery.

India is an increasingly influential player in the global pharmaceutical market. A pilot study, conducted in two major cities in India, Delhi and Chennai, explored the proliferation of substandard and counterfeit drugs in the market and discussed how the Indian state and federal governments could improve drug regulation and regulatory enforcement to combat this.

A provider of contract laboratory services and manufacturer of scientific instruments in the US, has opened a new European laboratory and office in Warwickshire, UK.

Faculty of Health Sciences at the University of Copenhagen will open the doors of its new research centre, The Novo Nordisk Foundation Centre for Protein Research. The centre is the result of an historic donation from the Novo Nordisk Foundation, which in 2007 gave the university €80 million for its establishment.

PerkinElmer and LEAP Technologies have entered into a resale agreement for ultra high performance liquid chromatography (UHPLC) and high performance liquid chromatography (HPLC) technology.

This month's "LC Troubleshooting" discussion will center on the recommendations of the CDER document, especially in terms of what it means from a practical method performance standpoint.

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Very short columns filled with 1.9 µm particles were evaluated for the ultra-fast analysis of pharmaceutical formulations. Local anæsthetic, mydriatic and anti-hypertensive agents were chosen as analytes and a method was developed and validated for each of these substances, according to ICH guidelines. Excellent quantitative performance was obtained using an optimized chromatographic system that reduces the importance of extra-column effects and cuts the analysis time to less than 15 s.

The regulatory world and associated guidance documents within the pharmaceutical industry is changing rapidly. This column gives an overview of what's happened since the start of the year.

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Ramipril impurities D and E are well-known degradation products of ramipril in the finished dosage form. A significant amount of an additional impurity was detected in ramipril tablets by an isocratic reversed-phase high performance liquid chromatography (HPLC) method on a short column. The structure of this impurity was proposed based on liquid chromatography–mass spectrometry (LC–MS) data using an electron spray ionization source. Structural elucidation using nuclear magnetic resonance (NMR) and infrared (IR) spectroscopy was facilitated by a newly developed preparative isolation method. This impurity was characterized as (2R,3aR,6aR)-1-[(R)-2-[[(R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (impurity L). Its identification, synthesis and characterization are discussed.

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Automated solid-phase extraction (SPE) has been used extensively with liquid chromatography–tandem mass spectrometry (LC–MS-MS) to facilitate high-throughput analysis in the pharmaceutical, diagnostic, and forensic toxicology areas. In this work, we demonstrate the use of a systemized approach to SPE method development and LC–MS-MS analysis. This approach provides dramatic savings in analysis time and takes advantage of new innovations in high performance liquid chromatography (HPLC) columns to provide the cleanest extracts for LC–MS injection.