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Over 9,000 Reference Standards from Eurofins PHAST GmbH for your daily laboratory work

  • EDQM / EP Reference Standards (Pharmacopoea Europaea / Ph. Eur.)  

  • ISA Standards (WHO)

  • ICRS Standards (WHO)

  • MHRA / BP Reference Standards (British Pharmacopoeia)

The search function will take you directly to the Reference Standards you require. If you also require a Reference Standard that is not included in the webshop, please contact our sales team directly: reference-standards@bpt.eurofinseu.com

Added value of the original pharmacopoeia standards of Eurofins PHAST GmbH

Ensuring your compliance - all Reference Standards originate without exception from the officially recognized institutions USP, Ph. Eur./EDQM, MHRA/BP.

As a “USP Authorized Distributor”, Eurofins PHAST GmbH is an official distributor for Reference Standards of the United States Pharmacopeia in Europe. 

  • Many years of experience in trading pharmacopoeia standards:

  ◦ Takeover of EU imports from the USA

  ◦ Handling of time-consuming customs clearance

  ◦ Fast delivery

  ◦ No minimum order value

  • Official pharmacopoeia standards recognized by numerous authorities - USP Standards, e.g. by the FDA
  • When used in accordance with the monograph, there is no need to develop your own standards, the equivalence of which must first be proven to the authorities Delivery always of the official batch

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Highest quality - the USP product lines

Highest quality - the USP product lines

If you want your original preparations and generics/biosimilars to achieve the expected therapeutic effect, then the USP products from us as your authorized specialist retailer can be an important step towards achieving this! As an independent, scientific non-profit organization, the USP works intensively to continuously improve the quality of medicines for greater patient safety.

A central component is the USP and the National Formulary (USP-NF) with the quality standards for chemical and biological drugs, active pharmaceutical ingredients (API) and excipients (inactive ingredients). The Reference Standards prescribed in the USP-NF give you added value that goes beyond vials and ampoules. This is because scientifically backed Reference Standards promote quality throughout the entire development and manufacturing process of human and veterinary medicinal products and give us the certainty that the medicinal products we use are safe and effective.

Pharmaceutical Analytical Impurities (PAI), which are not included in the Reference Standards, are another component. They are used for the timely identification, evaluation and control of possible impurities during method development and in the manufacturing process of active ingredients, excipients and finished medicinal products.

By opting for a USP product, you can be sure that you have made the best choice!

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Comprehensive range of Reference Standards and other Reference Materials from USP

USP Reference Standards (United States Pharmacopeia) for

  • Drug substances, excipients, impurities, degradation products, food additives, dietary supplements, compendial reagents, performance test tablets (Dissolution Performance Verification Standards)
  • Biologics, e.g. to ensure methods and process performance: monoclonal antibodies - mAbs, cell, gene and tissue standards, vaccine standards - mRNA, oligonucleotides, proteins, peptides, antibiotics, carbohydrates and heparins as reference preparations

Further USP product lines

  • Analytical Reference Materials (ARM)
  • Pharmaceutical Analytical Impurities (PAI)

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USP Biologics

As with chemical-based drugs, developers and manufacturers of biologics must ensure the purity and quality of their products. 

As an authorized distributor, we offer you a growing portfolio of USP Reference Standards that can be used throughout the biopharmaceutical product life cycle:

  • Monoclonal Antibodies - mAbs

  ◦ mAb Analysis guide

  • Cell, gene and tissue standards
  • Vaccine standards - mRNA
  • Oligonucleotide standards
  • Protein standards
  • Peptide standards
  • Antibiotic standards
  • Carbohydrate standards
  • Heparins as reference materials

For biologics and biosimilars, USP has focused on product families or classes and focuses on analytical methods, reference materials and standards to support testing.

Through us as its specialist distributor, it also offers reference materials to support the quality assessment of biological raw materials and bioproduction.

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USP Analytical Reference Materials - ARM

USP Analytical Reference Materials are characterized substances with supporting data suitable for a range of pharmaceutical applications:

  • For APIs (Active Pharmaceutical Ingredient) that may not be sold in the U.S. and for which USP does not have API or formulation monographs, USP offers Analytical Reference Materials (ARMs).
  • Analytical Reference Materials (ARMs) may also be used to support the development of generic products with complex APIs or for use in complex generic products where USP does not have API or formulation monographs.

Such reference materials may be important for quality assurance outside the US in other parts of the world. They are used there for analytical testing and research at various stages of the drug life cycle and for testing raw materials, laboratory equipment and other components used in the pharmaceutical, food and dietary supplement industries.

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USP Reference Standards for impurities

Impurities only discovered during production or in preparations already on the shelf can trigger costly drug recalls and result in official measures.

Impurities can occur during the entire manufacturing process as well as during transportation or storage of the medicinal products. The early use of USP impurity standards can limit the level of impurities throughout the product life cycle and thus minimize the risk of delayed product approval or a batch recall.

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USP nitrosamine impurities

An example of a high-risk impurity in some commonly prescribed drugs is the detection of elevated levels of nitrosamines - a probable carcinogen.

Additionally, the discovery of Nitrosamine Drug Substance Related Impurities (NDSRIs) has further complicated the problem. To assist pharmaceutical manufacturers and regulators, the USP has added the General Chapter <1469> on Nitrosamine Impurities to the United States Pharmacopeia (USP). This is intended to enable manufacturers and authorities to assess the presence of nitrosamines and implement appropriate control strategies and analytical procedures.

In addition, the USP has developed around 30 nitrosamines in the form of Reference Standards and pharmaceutical analytical impurities and made them available for use by professionals.

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USP Pharmaceutical Analytical Impurities - PAI

In addition to the monographed USP Reference Standards for impurities, the USP offers a growing catalog of non-monographed impurities with its Pharmaceutical Analytical Impurities (PAI) product line.

As a pharmaceutical manufacturer, you carry out risk assessments to identify and evaluate potential impurities that could arise during the manufacturing process at an early stage. This is because even small amounts of impurities can cause undesirable side effects or impair the efficacy of the drug.

The use of the USP's numerous Pharmaceutical Analytical Impurities (PAI) greatly facilitates the identification of these potential impurities. Range of applications:

  • Research and development - R&D
  • Method development
  • Production
  • Quality control
  • Stability testing
  • Monitoring after market launch

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USP Reference Standards for excipients

As inactive ingredients, excipients account for up to 90 % of a pharmaceutical drug. Therefore, the comprehensive control of their quality is crucial for the safety and efficacy of the entire drug product. Documentation standards provide the validated test methods for determining the identity, purity and quality of excipients, while the Reference Standards serve as official standards for comparison.