Reference standard
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
As an official USP, Ph. Eur., & BP distributor, Eurofins BPT offers access to over 9,000 pharmacopeial standards, and novel analytical reference materials (ARM) for APIs and complex generics where no monograph exists.
On-line ordering at: https://eurofins.myshopify.com/en
Development, qualification, requalification of reference standards
We qualify in-house reference standards (ex: pharmaceutical analytical impurities (PAI), USP nitrosamine standards, biologics, and more) and conduct annual requalifications under GMP. All materials are certified with a CoA to ensure they remain compliant over time.
Reference standard management
Storage, inventory, global logistic support. Materials are stored under ICH and extended climatic conditions, fully managed with proactive alerts when stock is low or requalification is due. We ship to global laboratory sites using qualified GMP logistics providers. For non-eu locations, we handle customs clearance and ensure controlled delivery conditions.