LGC updates most comprehensive catalogue of pharmaceutical reference substances
11 Jun 2015
LGC, Europe’s leading supplier of reference materials
, has updated its Pharmaceutical impurities and primary standards catalogue
. The 2015 edition now includes over 3,500 impurity and drug substance reference standards as well as a selected range of primary reference standards produced under ISO Guide 34.
The catalogue of pharmaceutical impurities and primary standards supports analytical testing, measurement and quality control of products across the pharmaceutical sector.
Dr Christian Zeine, Global Product Manager Pharmaceuticals, LGC, said, “LGC is committed to supporting the international scientific community by providing our partners and customers with solutions that enable them to deliver the highest quality analytical results. In this updated catalogue lab technicians will find an extensive list of starting materials, degradation and by-products for the quality control of APIs and their finished dosage forms.
“The catalogue also includes our new range of primary reference standards which fulfill ICH, FDA and other regulatory bodies’ requirements for pharmaceutical quality control, enabling us to meet our customers’ specific needs and continue to use science for a safer world. Primary standards by LGC should be used when no official standard from the pharmacopoeias exists for the given purpose.”
Impurities in a pharmaceutical substance can significantly change the effects and side effects of a drug. Therefore, it is important to have an accurate detection of impurities. The pharmacopoeial monographs regulate the legal definition but also the analysis and the limits of impurities in a given substance. A wide range of known impurities is listed in individual pharmacopoeial monographs, though a great number of these standards are not actually available from the pharmacopoeias. The impurity standards produced by LGC serve to fill this gap.
The increasing importance of impurity reference materials
is also becoming apparent in the registration of drugs, where an exact identification and quantification of susceptible impurities is required for an assured documentation.
LGC has successfully established a global reputation for the production of impurities, primary reference standards and working standards, and as a single source for the supply of pharmacopoeia reference materials. Its production site is accredited to ISO/IEC 17025 and ISO Guide 34.
An interactive version of the catalogue can be downloaded from the website www.lgcstandards.com
. All product codes in the interactive catalogue link directly to the LGC webshop and make online ordering easy.