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Pharma Newsletters >> Eurofins BioPharma Services Newsletter 21 - October 2018 >> Compendial Testing

Cost-effective, high-quality USP Reference Standards essential for compendial testing

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by Dietrich-Peter Kleine, Marketing Specialist, PHAST

The United States Pharmacopeial Convention (USP) sets primary standards for quality control and assurance in pharmaceutical development and manufacturing. It is the only provider of the official Pharmacopoeia standards for the analysis of pharmaceutical ingredients, per USP and the National Formulary. These official standards help ensure that product testing will meet GMP compliance requirements, e.g. of the U.S. Food and Drug Administration.

Eurofins BioPharma Product Testing has added a new subsidiary, Eurofins PHAST, a USP Authorised Distributor and only official source for Reference Standards of the USP in Europe for compendial testing.

Official USP Reference Standards can help save time and resources in quality control in the pharmaceutical manufacturing process, from raw materials through product development to finished products. USP Reference Standards are used to demonstrate identity, strength, purity, and quality for medicines, dietary supplements, and food ingredients. When used according to the monograph, there is no longer a need to invest in the development of internal standards where equivalence must be proven to the authorities. USP Reference Standards are rigorously tested and evaluated by several independent regulatory, academic, and commercial laboratories to confirm accuracy and reproducibility.

In total, Eurofins PHAST offers more than 7,000 Reference Standards, of that, more than 3,700 USP Reference Standards and 2,800 European Pharmacopoeia Standards. With this comprehensive offering, Eurofins PHAST provides exactly the Reference Standards clients need in daily routine QC analyses. In addition, the cooperation with Eurofins PHAST offers the following benefits:

  • A step ahead in GMP compliance
  • Always the official batch/lot deliverable
  • Verified quality, early warning in case of recalls or changes
  • Accepted by authorities, e.g. FDA
  • Fast delivery to clients’ sites:
    - EU-import from USA
    - Customs declaration

For its customers, Eurofins PHAST has set up the website www.reference-standards.com. After registration and receiving the password, the delivery programme stored in a protected area can be viewed. The trilingual website (English, German, and French) also offers the option of requesting a PDF catalogue containing the available Reference Standards and its selling prices. If the Reference Standard you are looking for can not be found, please contact the sales team at: reference-standards@phast.com. Please note that only written orders can be accepted.