Impurities have nowhere to hide with LGC Standards

LGC Standards presents their latest catalogue ‘Pharmaceutical reference substances and impurities 2009.’ In addition to its own products, the LGC Standards catalogue has been fully updated to include the latest listings from a wide range of suppliers, including all the major pharmacopoeia, making it a ‘must have’ for anyone involved in pharmaceutical analysis.

The catalogue includes the most comprehensive range of LGC Standards pharmaceutical impurities to date, with over 2400 impurity standards available. Accurate detection of impurities in a pharmaceutical substance is important, as they can change the effects and side effects of a drug significantly. Both major pharmacopoeias, the European Pharmacopoeia and the United States Pharmacopeia, emphasise that it is not sufficient to test impurities just according to the monograph, but to perform additional tests whenever there is evidence that the monograph cannot sufficiently control the impurities present.

LGC Standards is embracing internationally recognised ISO Guide 34 protocols with a future focus on certified reference materials and primary standards, in addition to the current range. During 2009, customers will begin to see reference standards for drug substances and major impurities converted to Certified Reference Materials (CRMs). This change will enhance the quality of customers’ analytical processes, as certificates of analysis will feature much more detailed information about the analytical characterisation of the substance.

The catalogue also includes the World Health Organisation (WHO) antibiotic standards for the first time - these standards are essential in the standardisation and quality control of antibiotic material and pharmaceutical products.

LGC Standards has successfully established a global reputation for the production of impurities and working standards, and as a single source for the supply of pharmacopeia reference materials. Our menu of custom services, including custom synthesis of impurities and metabolites, characterisation, certification, packaging and distribution, adds value to the scientific support we provide to our pharmaceutical customers.