FDA guidance on impurities in generic drugs drives LGC Standards’ expansion of product range

Recently issued guidance from the US Food and Drug Administration (FDA) states that, in addition to the pharmacopoeial monographs, generic substances must also be assessed in accordance with the International Conference on Harmonisation (ICH) guidelines. One of the vital elements of producing generic drugs is correctly identifying and quantifying impurities, and LGC Standards, Europe’s leading supplier of reference materials, lists over 2,600 impurity reference standards in its new pharmaceutical reference substances and impurities catalogue.

All LGC Standards impurities are synthesised and characterised in state-of-the-art laboratories near Berlin, Germany. The LGC Standards range of impurities for important active pharmaceutical ingredients (APIs) is constantly expanding – at a rate of more than two new standards per week since the last catalogue was issued in 2009.

In addition to the impurities, the new Pharmaceutical reference substances and impurities 2010-11 catalogue from LGC Standards includes up to date listings from all the major pharmacopoeia worldwide, making it an essential resource for anyone involved in pharmaceutical quality control.

The catalogue also contains a new product line of nearly 100 secondary pharmaceutical standards traceable to the US, European and British pharmacopoeias. The concept of secondary standards derived by direct comparison with pharmacopoeial reference standards is a proven one, acknowledged by all major regulation agencies and pharmacopoeias. These products are supplied with a certificate of analysis which documents the traceability.

The catalogue contains details of the World Health Organisation reference materials for use with the International Pharmacopoeia, which were unavailable until recently.

To obtain your copy of the new catalogue, please contact LGC Standards by email at pharma@lgcstandards.com or tel: +44 (0)20 8943 8480.