While widely recognised for our expertise in pharmaceutical raw material testing, Butterworth Laboratories also provides comprehensive analytical solutions for evaluating plastic and glass containers and packaging systems. Our services support specific analytical aspects of extractables and leachables investigations as part of wider packaging qualification programmes undertaken by clients or specialist E&L consultants and are in full compliance with both the European Pharmacopoeia (PhEur) and the latest revisions to the United States Pharmacopoeia (USP), covering the full lifecycle, from raw materials to finished packaging systems.
PhEur
- 3.1 Materials Used for the Manufacture of Containers.
- 3.1.3 Polyolefins.
- 3.1.4 Polyethylene Without Additives for Parental and Opthalmic Preparations.
- 3.1.5 Polyethylene With Additives for Parental and Ophthalmic Preparations.
Using advanced analytical techniques, we ensure plastic materials are safe, well-characterised, and fit for purpose. Our capabilities include polymer identification (e.g. IR spectroscopy and thermal analysis), extractables & leachables testing and physicochemical assessments, ensuring packaging materials meet stringent quality and patient safety requirements. Other tests include UV absorbance, Leachable Metals, Acidity/Alkalinity, and Sulfated Ash.
USP
In December 2025, the USP was revised to provide a more structured approach, with new chapters 〈661.1〉 and 〈661.2〉 that clearly separate material and finished system evaluation.
- 〈660〉 Containers – Glass. Tests include Buffering Capacity and Spectral Transmission. Additionally, Butterworth can also determine Leachable Metals.
- 〈661〉 Plastic Packaging Systems and their Materials of Construction. Tests include ID, UV Absorbance, Acidity/Alkalinity, Total Organic Carbon, Extractables and Additives.
- 〈661.2〉 Plastic Packaging Systems for Pharmaceutical Use. Tests as 〈661.1〉plus Terephthaloyl moieties and Ethylene glycol.
These USP chapters define the regulatory and analytical framework for assessing plastic packaging systems used in pharmaceutical products. Together, they ensure that packaging materials are suitable for their intended use and do not adversely impact product quality, safety, or efficacy.
Why Butterworth Laboratories?
Our integrated approach combines deep pharmacopeial expertise with state-of-the-art analytical technologies to deliver robust, regulatory-ready data. Whether qualifying materials or validating complete packaging systems, we help ensure your products remain safe, compliant, and ready for market.
Frequently Asked Questions
E&L testing identifies chemicals that could move from the packaging into the product. Extractables are compounds that can be extracted under extreme conditions, while leachables are those that actually migrate into the product during normal storage.
Packaging testing helps evaluate how packaging materials protect products during storage by assessing factors such as chemical migration and material compatibility throughout the product’s shelf life.
Yes. Analytical data generated from packaging and container testing can support regulatory submissions, quality investigations, supplier qualification, and ongoing stability programmes.
Butterworth Laboratories provides analytical testing to support extractables and leachables assessments; however, we do not offer full-scale end-to-end extractables & leachables study programmes, that include toxicological risk assessment and complete study design management.
