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Technical / white paper
Container Testing: Quantifying Metal Contaminants - SGS
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.
Technical / white paper
SGS-Lab-Disulfide Bonds…. - SGS
02-Apr-2012 -
The disulfide bond is a post-translational protein modification with significant implications for structure and function. Predicting the disulfide-bonding pattern in a particular protein poses many analytical challenges as outlined in this article.
On-Demand Supplier Webinar
Meet the requirements for GSDP for pharmaceutical products - SGS
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.
Technical / white paper
PHARMACEUTICAL GAS ANALYSIS: A NEW TREND IN THE REGULATORY FOCUS - SGS
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...
Technical / white paper
White Paper on USP Elemental Impurities - SGS
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.
Technical / white paper
White Paper on Forced Degradation Studies - SGS
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.
Technical / white paper
White Paper on Residual DNA-Based Services - SGS
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.
Technical / white paper
Batch Retesting for Product Release in the EU - SGS
12-Sep-2011 -
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
Application note
Monoclonal Antibodies Characterization - SGS
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.
Technical / white paper
Glycosylation of Proteins: Structure & Analysis - SGS
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...
Technical / white paper
Sample Prep Proposed USP<233> Elemental Impurities - SGS
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.
Technical / white paper
How to Approach Identification of Anomalous Peaks - SGS
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...