Brochures
Extractables & Leachables (E&L) and Impurities Center of Excellence
Our Canton, MA site is Solvias’ Center of Excellence for E&L and genotoxic impurities testing, including nitrosamines. This state-of-the-art laboratory offers cGMP testing services supporting a wide range of container-closure, packaging, delivery, and manufacturing systems across small molecules, biologics, and cell and gene therapies. With a risk-based approach grounded in regulatory guidance and over 20 years of scientific expertise, our team has successfully completed more than 100 E&L programs, with zero Complete Response Letters (CRLs) issued.
Our Expertise: Extractables & Leachables
We offer a complete portfolio of E&L services across multiple modalities and delivery systems. Leveraging advanced high-resolution accurate mass (HRAM) spectrometry, we detect, identify, and quantify impurities at trace levels, meeting even the most stringent analytical evaluation thresholds (AETs) and detection limits:
Drug Delivery Systems
- Orally Inhaled & Nasal Drug Products (OINDPs)
- Parenterals & Ophthalmics
- Transdermal Patches & Topicals
- Oral Solutions, Suspensions, & Solids
- Single-Use Systems
Genotoxic Impurities Testing
Solvias offers a comprehensive portfolio for the detection and quantification of genotoxic impurities, including:
- Nitrosamine Drug Substance Related Impurities (NDSRIs)
- Small Molecule Nitrosamines
- Polycyclic Aromatic Hydrocarbons (PAHs)
- Alkyl Halides
Regulatory Expertise You Can Rely On
We help you navigate complex and evolving regulatory expectations, including:
- USP <665> (2022/2026) – Plastic Components and Systems Used to Manufacture Pharmaceutical and Biopharmaceutical Products
Effective May 1, 2026, this chapter introduces a standardized, risk-based approach for qualifying extractables and leachables from single-use systems. Solvias helped pioneer early E&L studies in this area and contributed to the development of the BPOG protocols that shaped USP <665>. - USP <1663> (2020) – Assessment of Extractables Associated with Pharmaceutical Manufacturing, Packaging, Storage, Distribution, and Administration of Dosage Forms and their Constituents
- USP <1664> (2020/2024) – Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
- FDA Control of Nitrosamine Impurities in Human Drugs Guidance (2020/2021/2024) The FDA’s evolving guidance outlines expectations for identifying, evaluating, and mitigating the risk of nitrosamine impurities in drug products. The latest 2024 update recommends conclusion of NDSRI confirmatory testing of drug products and submission of required changes in drug applications by August 1, 2025.
By the Numbers: Solvias’ Global Footprint
With six facilities worldwide, our operations span 25,000 m² of lab capacity, supported by 800+ employees. We serve over 175 customers globally, including 19 of the top 20 pharmaceutical companies. Our locations include Canton (USA), Kaiseraugst (HQ) and Basel (Switzerland), Utrecht (The Netherlands), Hombourg (France), and Research Triangle Park (USA).
A Trusted Partner for E&L Assessments
Solvias conducts over 100 customer audits annually and maintains a dedicated global team of 30+ quality experts. With a track record of 0 critical findings in 2023, we ensure compliance with global regulatory agencies and uphold the highest quality standards.
What Our Clients Say
“Solvias’ scientists are highly trained, innovative, and business-minded. Their analytical solutions are outstanding.”
“Their project managers are flexible, responsive, and committed to our success.”
“Solvias is not just a vendor—they are an extension of our team.”
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