As an industrialist, you wish to perform USP 662 compliance analysis of your metal packaging
Metal packaging used for pharmaceutical products must ensure the safety, stability, and regulatory compliance of the drug.
USP 662 (Metal Packaging Systems and Their Materials of Construction) defines the tests required to verify that this packaging does not release undesirable substances and that it is compatible with the product.
Our analytical services according to USP
Through our state-of-the-art analytical resources and our teams specializing in metallic materials and pharmaceutical analysis, we perform all the tests required by the USP 662 standard:
Chemical characterization of your packaging materials and their properties
Analysis of extractables and leachables
Internal or external surface analysis
Physicochemical tests (defined according to the type of medicinal product and the type of plastic)
Melting point or glass transition point
Analysis of an unknown particle and comparison with packaging or delivery material
Study of the device's physical properties: thickness, porosity, etc.
Analysis of hazardous substances
Analysis of additives purity
The FILAB laboratory assists you with your analysIs according to USP 662
Regulatory context: the requirement of USP 662
USP 662 is part of the United States Pharmacopeia (USP) guidelines, alongside other standards such as USP 1660, ICH Q3D, and USP chapters 232 and 233 related to trace metals.
It applies to metal packaging systems used in the storage, transport, or manufacturing of pharmaceutical products.
The tests aim to:
- Identify metals that may interact with the drug,
- Quantify the release of metal ions,
- Evaluate corrosion and chemical compatibility,
- Ensure patient safety and drug stability.
Why choose FILAB
Dual expertise in metallic materials and pharmaceutical regulations
Responsiveness and personalized support
Complete analytical platform on a single site
Interpretation and consulting
Our analysis according to the USP
FAQ
Our services target players in the pharmaceutical sector:
- Pharmaceutical laboratories and drug manufacturers
- Producers of metal packaging (caps, stoppers, containers, tanks, reactors, etc.)
- Quality, R&D, Regulatory Affairs, and Industrialization services
USP 662 is a chapter of the United States Pharmacopeia that defines the requirements for metallic packaging systems used in the pharmaceutical industry.
It aims to ensure that metallic materials do not release undesirable substances and that they are chemically compatible with the pharmaceutical product they contain or transport.
USP 662 applies to all metallic systems in direct or indirect contact with the drug, such as:
- stainless steel or aluminum containers,
- metal caps and closures,
- reactors, tanks, pipelines, and pharmaceutical production equipment.
These components must demonstrate their inertness and safety with respect to the product.
The tests include:
- the elemental composition of the material (ICP-MS, ICP-OES, SEM-EDS),
- metal ion extraction and release tests,
- corrosion and chemical compatibility studies, pH, conductivity, and total organic carbon (TOC) measurements.
These analysis allow for the evaluation of the material's behavior in contact with the drug.
- USP 661 covers plastic and elastomeric packaging.
- USP 662 applies specifically to metal packaging and packaging systems.
Both chapters share the same objective: to ensure container-content compatibility and prevent any contamination of the pharmaceutical product.
Yes, for companies that market their pharmaceutical products in the United States, compliance with USP 662 is one of the requirements of the United States Pharmacopeia.
Even in other markets, it is often used as an international standard to demonstrate the quality and safety of metal packaging.
