Pharmaceutical analytical impurities (PAI)
These support method development, stability testing, manufacturing, and quality control by helping identify trace impurities that could impact product safety.
GMP-compliant reference standard procurement
Quality assured at every stage
From sourcing to shipping
Ensuring the quality and regulatory compliance of your pharmaceutical product demands rigorous control of impurity levels throughout its lifecycle—an objective that hinges on the use of reliable and appropriate reference standards. Whether you're testing raw materials, APIs, or finished products, the reference materials you use must be validated, well-documented, and expertly managed throughout their lifecycle to minimise the risk of delayed approval or batch recall.
However, sourcing, qualifying, storing, and distributing reference standards is a complex and resource-intensive process, especially when dealing with sensitive materials or working across multiple global sites.
The Eurofins BioPharma Product Testing (BPT) network of laboratories offers a fully integrated Reference Standard procurement, management and on-line ordering service designed to simplify your operations.
Services
USP nitrosamine standards
In response to evolving regulations, we offer 30+ USP reference standards and pharmaceutical analytical impurities (PAIs) to help control nitrosamines, supported by USP general chapter <1469>.
Sourcing, qualifying, storing, and distributing
Official USP distributor
As an official USP distributor, Eurofins BPT offers access to over 9,000 pharmacopeial standards, including USP, Ph. Eur, BP, and novel analytical reference materials (ARM) for APIs and complex generics where no monograph exists.
GMP qualification & requalification
We qualify in-house reference standards and conduct annual requalifications under GMP. All materials are certified with a CoA to ensure they remain compliant over time.
Storage & inventory management
Materials are stored under ICH and extended climatic conditions, fully managed with proactive alerts when stock is low or requalification is due.
Global logistics support
We ship to global laboratory sites using qualified GMP logistics providers. For non-EU locations, we handle customs clearance and ensure controlled delivery conditions.
With ever-tightening regulations and the risks posed by impurities like nitrosamines, it’s more important than ever to maintain robust control over reference materials. By partnering with Eurofins BPT, you will gain access to a dependable, GMP-compliant system that supports compliance, efficiency, and peace of mind at every step.
On-line ordering at: https://eurofins.myshopify.com/en