Analysis Laboratory in accordance with USP 661-1
The safety of a medicine depends closely on its container. Chapter USP <661.1> “Plastic Materials of Construction” defines the testing requirements for polymer materials used in the manufacture of pharmaceutical packaging systems (packaging) and drug delivery devices.
The goal is to establish the safety profile of the construction material before it is even turned into a final packaging system.
As an industrial manufacturer, you want to carry out analyses according to USP 661-1
Why is USP 661.1 compliance essential?
Unlike broad tests, USP <661.1> requires specific characterization for each polymer family. This chapter has become the benchmark for:
Ensuring material identity: verifying that the delivered polymer matches the specifications.
Assessing chemical safety: ensuring that potential extractables do not pose a toxicological risk.
Meeting FDA requirements: providing the data needed to submit your CMC dossiers.
Polymers concerned and testing protocols
USP 661.1 describes specific tests for the most common material families:
Polyethylene (PE) : high- and low-density (HDPE / LDPE).
Polypropylene (PP) : homopolymers and copolymers.
Polyethylene Terephthalate (PET) : and PETG.
Cyclic polymers: COC and COP.
Polyvinyl chloride (PVC) : plasticized and unplasticized.
The FILAB laboratory supports you with your analyses according to USP 661-1
FILAB's analytical approach
To qualify a material according to USP <661.1>, our laboratory uses a three-step strategy:
Use of spectroscopic techniques FTIR (Fourier-transform infrared spectroscopy) and thermal analysis DSC (Differential scanning calorimetry) to confirm the identity and thermal properties of the material.
These tests are carried out on aqueous and organic extracts to assess overall purity:
UV absorbance: detection of organic impurities.
TOC (Total Organic Carbon): measurement of the organic load.
Acidity or Alkalinity.
Heavy metals / Trace elements: analysis by ICP-MS.
USP <661.1> also requires an inventory of additives such as antioxidants, plasticizers or slip agents, tailored to each type of polymer.
Our technical resources for analysis according to USP 661-1
To provide you with reliable analyses and interpretations, FILAB has a complete analytical platform suited to the analysis. These include in particular:
- GC-MS, HPLC or UHPLC/MS/MS for the search, identification and quantification of organic compounds present in solvents, UV stabilizers, antioxidants, colorants, inks, detergent residues, sterilization residues, polymer residues… that have been extracted and/or released from the material by a standardized simulant
- ICP-AES and ICP-MS particularly suited to mineral or metallic contaminants or additives, such as heavy metals, mineral or metallic fillers, colorants…
- microscopy MEB-EDX, a true rapid and versatile diagnostic tool for assessing the surface condition of the material after aging, and for observing particles, deposits…
For the pharmaceutical sector, the FILAB laboratory follows the ICH Q3E guideline.
- Identification of leachables according to USP <1664>
- Identification of extractables according to USP <1663>
- Extractables & Leachables analysis according to BPOG (Best Practice Operating Guidelines)
- Packaging analysis and verification: interactions with the drug product according to <USP 661.2>
- Analysis of leachables from process materials according to USP <665>
- Identification of extractables according to USP <1665>
Associated services offered by the FILAB laboratory
Chemical characterization of materials and their properties used for your packaging
Physicochemical tests (defined according to the type of medicinal product and the type of plastic)
Melting point or glass transition
Migration test
Analysis of an unknown particle and comparison with the packaging or delivery material
Study of the device’s physical properties: thicknesses, porosity…
Analysis of hazardous substances
Purity analysis of additives
Why choose FILAB for your USP 661-1 analyses?
- COFRAC ISO 17025 accreditation and GMP environment
Guarantees technical competence, traceability of our measurements, and the enforceability of our analytical results before French and European regulatory authorities, as well as the U.S. FDA. - Comprehensive multi-technique analytical platform
- Mastery of regulatory thresholds (AET, SCT…).
- Structured reports for your regulatory submissions
Each FILAB report is structured for direct integration into your files: Module 3 CTD, IMPD, STED, BER, 510(k) or PMA dossier. Our deliverables include detailed operating conditions, annotated chromatograms, identification/quantification tables, and toxicological assessment of the compounds detected.
Our FAQ
USP 661 is a standard from the United States Pharmacopeia (USP) that applies to plastic packaging used in the pharmaceutical industry. It is a specific chapter in the USP standards that provides guidelines and criteria for packaging materials used in medicines and pharmaceutical products. Its purpose is to ensure that polymeric materials do not affect human health.
In 2016, the USP expanded the testing standards in chapter 661 to further support packaging safety; these new chapters are USP (661.1) and USP (661.2). These chapters will come into effect on December 1, 2025, but early adoption is permitted and encouraged.
Yes, the DSC analysis can be used to verify the nature and thermal stability of polymers, a key step in assessing their compliance with USP 661 requirements for plastic materials in contact with medicines.
- Patient safety : limiting exposure to potentially harmful substances.
- Product efficacy : ensuring that the packaging does not alter the properties of the medicines.
- Regulatory compliance : meeting international requirements for products distributed globally.
USP <661.1> qualifies the raw material (e.g., PE pellets), while USP <661.2> concerns the final packaging system (e.g., the finished bottle).
It is necessary, but often supplemented by an extractables and leachables (E&L) study according to USP <1663> or <1664> to assess the actual interaction with the formulation.
To get a quote, you can contact our teams via our contact form, by phone, or by email.
All you need to do is send us your requirements (material type, analysis requested, applicable standard, urgency, number of samples, etc.). We will then send you a tailored technical and pricing proposal within 24-48 hours.
Lead times vary depending on the nature of the analysis and the complexity of the expert assessment project.
FILAB is committed, however, to providing fast turnaround times suited to your constraints and industrial urgencies.
