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'Impurities' refers to synthetic impurity standards and known metabolites of APIs that have been resynthesised to the highest purity, and are supplied with full analytical data, allowing precise identification and quantification of extraneous molecules that may be present in a drug.  Impurities in active pharmaceutical ingredients (APIs) can change the properties of a drug significantly and the importance of impurity reference materials has become clear for the registration process, where exact identification and quantification of impurities is essential for documentation.  Our collection of over 800 impurity reference standards derives from more than 300 APIs developed over 10 years serving the pharmaceutical industry.

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