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| As scientists in Pharmaceutical and Analytical Development groups are called upon to identify an ever varying and always increasing number of APIs and unknown or unexpected impurities, many researchers are looking for more high performance analytical tools to better deal with these complex problems. Many groups rely upon traditional HPLC detection methods for much of their work, with a Mass Spectrometer available to aid in accurate mass determinations of unknown degradants or impurities routinely found in drug substances and drug products during routine development operations. However, the latest generation of more complex and larger molecular weight therapeutics and biotherapeutics has greatly complicated the analytical challenges in developing these types of molecules and the methods and analytical tools of the past are becoming increasingly less well suited for efficient and effective use. |
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| Residual solvents in pharmaceuticals are defined as volatile organic chemicals that are used or produced in the manufacture of drug substances, excipients or in the preparation of drug products. Because residual solvents do not provide therapeutic benefits, they should be removed, to the extent possible. Drug products should contain no higher levels of residual solvents than can be supported by safety data. Looking forward to the implementation of a revised USP 467 method, Teledyne Tekmar evaluated the new protocol, therefore this application will comply with the procedure and criteria changes set forth in the USP30 NF25, Second Supplement (effective December 1, 2007) and the interim revision announcement. |
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| Many pharmaceutical companies have made considerable investments in the development of various biotherapeutics. To help facilitate the development of biotherapeutics, Mass Spectrometry can be used as a powerful tool for all types of product analyses ranging from protein and peptide fingerprinting and sequencing, impurity and degradant identification, to analysis of post-translational modifications. |
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| The current regulatory demands of the industry require analytical instruments that can measure at increasingly lower detection limits with high precision and accuracy. For example, some ultrapure applications in TOC require trace level detection to ensure highly accurate and precise results. The Shimadzu Wet Chemical TOC-VW is the only TOC analyzer on the market that offers three oxidation techniques  UV light, persulfate, and heat  in a single instrument. This allows for optimal TOC sensitivity with a method detection limit of 0.5 ppb. This application note demonstrates how the TOC-VW meets the demands of ultrapure applications by achieving practical quantitation below 5 ppb. |
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| In this era of shrinking budgets, scientists are continually searching for instrumentation that is capable of 'multi-tasking'. FTIR microscopy fits this niche by performing routine analysis on tablets, caplets, and packaging materials in the pharmaceutical industry. In this paper by Shimadzu Scientific Instruments, the usefulness of FTIR microscopy to a pharmaceutical scientist is evaluated. |
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| Ion chromatography incorporates special column chemistries and hardware to optimize the analysis of ions. These advantages are particularly useful for the analytical challenges encountered when analyzing for critical components in process solutions in industrial settings. However, the real take home lesson for on-line analysis is that it frees up the analyst for other more important tasks. |
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| No longer just a fingerprinting method, X-Ray Powder Diffraction is becoming a user-friendly PAT tool. This white paper discusses how accessible XRPD systems address the needs of today's pharmaceutical industry, which requires a multi-disciplinary approach to pharmaceutical product design. |
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| Many early laboratory information management systems (LIMS) have outlived their original usefulness. Time for an upgrade? This brief white paper by LabVantage provides a heuristic for your decisionmaking. |
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