Accurate Results. No False Positives. Regulatory Confidence.

Benzene is one of the most strictly regulated impurities worldwide. Classified as a Class 1 carcinogen (ICH Q3C), its maximum allowable limit in pharmaceuticals and cosmetics is extremely low, only 2 ppm.

In formulations containing benzoyl peroxide (BPO), widely used in acne treatments, dermatology products, and topical pharmaceuticals, benzene formation poses a hidden risk. Not necessarily due to manufacturing but often due to how the product is analyzed.

The Problem with Standard Methods

Traditional methods, including Ph. Eur. 5.4 (Residual Solvents), rely on high-temperature headspace GC conditions that can artificially decompose BPO into benzene during analysis.

This leads to:

• False benzene detections
• Inflated results
• Regulatory concerns
• Potential market recalls

Labsense Provides The Solution

Throughout 2024, Labsense’s R&D team, in collaboration with scientific institutions and supported through the PK.1.1.06. national innovation program (Croatian Ministry of Economy and Sustainable Development)*, developed a low-temperature GC headspace method specifically designed to prevent BPO degradation.

By applying controlled conditions, we ensure that the analysis reflects the true benzene content in your finished product, not artificially generated levels.

Key Benefits of Our Method:

• No artificial benzene formation – prevents thermal breakdown of BPO
• Accurate, real benzene quantification – fully validated on finished products
• Regulatory compliance assurance – confidently demonstrate compliance with 2 ppm (ICH Q3C / EMA)
• Matrix-specific validation – each product is validated on its own matrix; no one-size-fits-all
• Expert scientific support – direct technical consultation available for your regulatory team

Why This Matters for Your Brand:

• Protects your products from unnecessary recalls
• Provides robust documentation for authorities
• Secures your regulatory compliance globally
• Strengthens your position on the market

*Co-funded under the Croatian national recovery and resilience plan (2021–2026).

For more information contact us here.