04-Nov-2013 - The USP is continuing to modify a proposal for using inductively coupled plasma (ICP) and ICP-mass spectroscopy (ICP-MS) to detect contaminating heavy metals in drug products. The new USP <233> describes testing methods to detect elements of interest specifically, accurately...
30-Jun-2009 - SGS
invites you to attend a free webinar to gain an overview on how to ensure the quality and integrity of your pharmaceutical products during all aspects of the storage and distribution process.
31-Mar-2010 - More attention is being focused on gases role as an excipient in pharmaceutical development. Download SGS’s Technical Bulletin and learn more about cGMP monitoring and quality testing including contamination control...
20-Sep-2010 - The USP has completed its revision on how heavy metals testing will be performed for drug products, drug substances, excipients and dietary supplements. This white paper outlines the main points and outcome of this highly anticipated change.
08-Nov-2010 - The stability of a drug product or a drug substance is a critical parameter which may affect purity, potency and safety. This white paper outlines how to approach a forced degradation versus a real-time stability study.
31-Jan-2011 - Accurate quantification of residual DNA at each purification step of a biopharmaceutical is essential. This paper outlines the analytical procedures available to measure this residual DNA and the advantages and drawbacks to each.
The sale of medicines in the EU is regulated to ensure their efficacy and safety. For medicines manufactured outside of the EU/EEA, each product batch must obtain certification in the importing country.Download this paper for the regulatory details
14-Nov-2011 - A number of new monoclonal antibody products and monoclonal antibody biosimilars are in development, all require extensive characterization to obtain the necessary approvals for clinical trials and eventually marketing approval. Download this paper to read more.
06-Nov-2011 - Glycosylation is one of the most widely observed, and structurally diverse, forms of post-translational modification of proteins and glycans have been shown to have a range of specific biological roles. Mass spectrometry-based techniques provide an extremely powerful tool for glycan...
30-Jan-2012 - Proper sample preparation is crucial when analyzing for trace metals using inductively coupled plasma (ICP). This paper illustrates how solubility of the test article may not be the primary factor when choosing a sample preparation method.
22-Feb-2012 - The sudden appearance of an unknown peak during an HPLC analysis of a pharmaceutical product can be a critical finding causing delays and requiring considerable resources to resolve. The unknown peak can be caused by many things ranging from simple...
05-Mar-2012 - With USP <661> colorimetric methods for detecting heavy metal contaminants known to be inadequate at trace levels, SGS conducted experiments to measure the impact of extraction, solvent, and detection techniques using proposed USP <232> methodology.