News
06-July 2010 –
FDA guidance on impurities in generic
drugs drives LGC Standards’ expansion of product
range
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.
-Ends-
Notes to
editors