In response to the most recent revision for USP <1660> Evaluation of the Inner Surface Durability of Glass Containers, SGS has taken the lead in optimizing, validating and supporting the newest recommendations of applying the ICP impurities testing portion of the standard to meet current guidelines. Test solutions can be analyzed from both timed stability samples as well as those created under accelerated aging conditions.
One of the most critical evaluations of determining the suitability of a given glass container for a specific product is the potential increase of SIO2 concentration in the drug product over normal stability or when subjected to accelerated conditions. This portion of the overall testing evaluation combined with the additional recommended testing methods, provides valuable information of the potential of a drug product to cause formation of glass particles and delamination of the inner glass surface.
CSL uses robust methods to accurately determine the concentration of Silicon in drug product or other appropriate matrices. These methods satisfy the requirements of USP <1660> ICP-MS testing and provide the critical information needed for product development and non-conformance investigations. CSL has 20+ years of experience with the analysis of trace elements via ICP-MS, and has conducted over 1,100 validations, verifications and risk assessments within the Pharmaceutical industry over the past 3+ years alone. Trust us to assure the analytical needs of your USP <1660> project are met!