Solvents play a critical role in pharmaceutical manufacturing, but their presence must be tightly controlled. Even in trace amounts, residual solvents can affect the quality, safety, and efficacy of your product, with the potential to cause delays, batch failures, or regulatory scrutiny if not effectively managed.

Residual solvents are often difficult to detect, especially in complex matrices. Complete removal during production is more difficult still, with the identification of unexpected or elevated levels requiring a rigorous, highly sensitive testing process.

The Eurofins BioPharma Product Testing (BPT) network of laboratories offers industry-leading residual solvents testing services across all classes of solvents (Class 1, 2, and 3) according to USP <467> and other regulatory guidelines. Our teams have the technical knowledge, regulatory insight, and state-of-the-art instrumentation to deliver the accurate data you need, when you need it.

We use validated direct injection gas chromatography (GC), Headspace GC, and HPLC methodologies. These technologies enable us to detect and quantify residual solvents with high precision, even at the lowest concentrations.

Flexibility is a key part of our offering with the option of a self-validating approach that results in a lower cost with samples only needing to be analysed once or twice a year.

Every project is undertaken by a dedicated team of experts who understand the complexity of pharmaceutical development and manufacturing. With harmonised systems across our global network of GMP-compliant laboratories, we ensure consistent quality and timely delivery, helping you to avoid costly delays and maintain regulatory compliance.

Whether you're working with well-known excipients or novel materials, the tailored services Eurofins BPT offer help you control risk, meet regulatory expectations, and protect patient safety at every stage of production.