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

06 July 2010

New pharmaceutical reference substances and impurities catalogue from LGC Standards helps drug firms meet FDA guidelines

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.

Notes to editors

About LGC Standards

LGC Standards (www.lgcstandards.com) provides products and services to improve measurement and quality control within the laboratory, and is part of LGC, whose Science & Technology Division acts as the UK National Measurement Institute for chemical and bioanalytical measurements. LGC Standards supplies over 20,000 reference materials, pharmaceutical impurity reference standards, proficiency testing and training in analytical quality. LGC Standards is headquartered in Teddington, Middlesex, UK. Its global centre for excellence in proficiency testing is located in Bury (Greater Manchester). LGC Standards has offices in France, Germany, Italy, Poland, Spain, Sweden, China, Russia and the UK, a joint venture presence in India, and representatives in Bulgaria, Czech Republic, Finland, Hungary, Ireland, the Netherlands, Romania, Turkey and the US.

About LGC

LGC (www.lgc.co.uk) is an international science-based company and market leader in analytical, forensic and diagnostic services and reference standards. A progressive and innovative enterprise, LGC operates in socially responsible fields underpinning the safety, health and security of the public and the regulation of industry, for UK government departments and blue chip clients.
LGC operates internationally through four divisions - LGC Forensics, LGC Genomics, LGC Standards and LGC Science & Technology, which includes specialist laboratories delivering contracts for the Department for Business, Innovation and Skills (BIS) and supporting LGC's designated role as the UK's National Measurement Institute for chemical and bioanalytical measurement.
Our operations are extensively accredited to international quality standards such as ISO 17025. With headquarters in Teddington, South West London, the LGC Group employs 1500 staff in 28 laboratories and centres across Europe and at sites in India, China and the US. Privatised in 1996 and now majority-owned by funds managed by Bridgepoint, LGC was founded almost 170 years ago as the Laboratory of the Government Chemist - a statutory function maintained by LGC today.