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During the manufacture of active pharmaceutical ingredients (APIs), the formulation of drug substances, and therapeutic fill and finish, the removal of residues from manufacturing equipment is performed by a series of cleaning procedures. It is imperative that the production equipment be properly cleaned in order to avoid cross-contamination of drug products.1-3 The efficiency of the cleaning procedures must be demonstrated through cleaning validation. This involves demonstrating that residual API, starting material, intermediates, and impurities have been removed from the production equipment.

News All the news from September 2005 Opinion Zosimus provides a controversial look at the trend of selecting monolithic columns and asks if they are all that they are cracked up to be. Benefits of the pretreatment step in purifying water for the LC-MS analyses Two specialists from Millipore provide their discoveries on this subject. Country focus The growing importance of the Chinese analytical science market is the focus this month. Q&A Damian Morrison from Waters speaks to The Column about its BEH technology and how it marks a new milestone in chromatography. Supplies & services

Millipore Corporation (Billerica, Massachusetts) announced that it recently has acquired over 90% of NovAseptic AB (Gothenburg, Sweden) shares. Millipore is in the process of acquiring the remaining shares from the minority shareholders.

J. Peterson, S. henderson, and B. Richter, Dionex Corporation

This article gives an overview of screening methods for the detection of antimicrobials, including dilution and diffusion methods and bioautography, mainly direct bioautography. The thin-layer chromatography method with direct bioautography was worked out to analyse enrofloxacin and ciprofloxacin residues in milk.

Where the wizard stands behind the curtain working levers.

This article looks at the use of electromigration techniques to determine microorganisms, such as viruses, bacteria and other biologically important macromolecules (erythrocytes), in medical analyses. It was found that electromigration techniques could be used for the identification of several viruses, including the identification of a specific marker for the Hepatitis C virus infection and another for a urinary tract infection. The determination of cell viability and the quality control of probiotics and consumer products that contain active bacteria is also possible using electromigration. Special attention is paid to the modification of capillary wall surfaces using different monomers and the application of monolithic columns to determine active bacteria in pharmaceutical products using capillary electrochromatography (CEC) conditions. This approach represents a new frontier for separation science and the possibility to apply it in medical diagnosis.

Emerald expansion

News All the news from August 2005 Opinion Zosimus considers the current state of chromatography research and suggests a possible link to the lack of methods available in food testing. Market trends & analysis Glenn Cudiamat provides a report on the food and beverage industry with particular reference to the types of analytical instrumentation involved. Country focus This month's focus looks at where chromatography has come in Russia since its discovery by Mikhail Tsvet, its Russian founder. Q&A John Gilbert, Sales Director of JEOL (UK) Ltd, talks to The Column about its AccuTOF-DART system, Gold Award Winner at this year's Pittcon. Supplies & services

The author takes a look at the problem of usually broad peaks and covers some techniques that will help determine the reasons behind them.

Columnist Ron Majors discusses methods that can be used to isolate large amounts of proteins from crude biological samples.