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Elemental Impurity Analysis in Pharmaceuticals and Implementation of ICH Q3D Monday, July 18, 2016 Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these...

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Enhanced Sampling and Calibration Procedures for Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD Thursday, January 21, 2016 In recent times, there has been a large increase in the type and number of products packaged using modified atmosphere packaging (MAP) procedures....

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Enhanced Residual Solvents Analysis: A Practical Approach to Sampling, Transport, Storage and Analysis Monday, August 03, 2015 Residual solvents are organic volatile chemicals used or produced in the manufacture of active pharmaceutical ingredients (API), excipients or drug products, which remain in the material at the...

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Amino Acid Analysis by High Performance Liquid Chromatography (HPLC) using Post-Column Derivatisation with Ninhydrin and Dual Wavelength Detection Monday, April 13, 2015 The European Pharmacopeia is moving away from the thin layer chromatography technique for the determination of ninhydrin-positive substances, to more specific and sensitive methods using...

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Elemental Impurity Analysis in Pharmaceuticals Tuesday, December 09, 2014 A method to identify the presence of heavy metals in pharmaceuticals was introduced in the United States Pharmacopeia more than 100 years...