USP Chapter 661.2 applies specifically to the primary plastic packaging components and systems of finished drug products, whether vials, bags, prefilled syringes, cartridges, or any other packaging in direct contact with the product.
It covers the sum of the packaging components that together contain the drug product, including closures (rubber stoppers, aluminum seals, laminated caps).
As a manufacturer, you want to carry out analyses according to USP 661-2
What tests are required according to USP 661-2?
USP 661-2 defines several categories of tests, the application of which depends on the type of packaged dosage form and the characteristics of the packaging system. The tests are based on the use of standardized extraction solutions, including solution C1 (purified water), selected according to the nature of the drug product and the conditions of use. The aqueous extract is obtained by filling the system to its nominal capacity, then subjecting it to a controlled heat treatment.
Test / Parameter | Oral & topical dosage forms | All other forms |
UV absorbance (230–360 nm) | Required | Required |
Acidity / Alkalinity | If liquid product | If liquid product |
Total organic carbon (TOC) | Required | Required |
Appearance of the solution (color + clarity) | Required | Required |
Total terephthaloyl groups | PET / PETG only | PET / PETG only |
Ethylene glycol | PET / PETG only | PET / PETG only |
In vitro biological reactivity (USP <87>) | Not required | Required |
Chemical suitability assessment (E&L) | Risk-based approach | Risk-based approach |
Spectral transmission | If light protection | If light protection |
FILAB’s laboratory supports you with your analyses according to USP 661-2
FILAB’s Analytical Approach
FILAB offers a complete qualification service for plastic packaging systems according to USP <661.2>, from the preparation of Solution C1 through to the delivery of the report. Our services are tailored to the nature of your system, your dosage form, and the requirements of your regulatory dossier.
We handle the preparation of Solution C1 according to the extraction protocol appropriate for your system (121°C, 100°C, 70°C or 50°C depending on its thermal resistance), as well as all required physicochemical tests: UV absorbance (230–360 nm), acidity/alkalinity for liquid products, total organic carbon with criteria adjusted by volume, and visual assessment of appearance (color and clarity) according to USP reference standards.
For polyethylene terephthalate systems, FILAB carries out the two required specific analyses: quantification of total terephthaloyl groups by multi-media extraction (alcohol, heptane, water) at 49°C for 10 days with spectrophotometric reading, and measurement of residual ethylene glycol by disodium chromotropate colorimetry after oxidation with periodic acid. These two analyses are critical for PET bottle dossiers intended for oral and injectable products.
FILAB supports your extractables and leachables studies as part of the chemical suitability assessment required by USP <661.2>. Our experts advise you on study design according to the principles of USP <1663> and <1664> chapters, taking into account the risk associated with your dosage form and your regulatory requirements (FDA, EMA, ANSM).
For packaging systems intended to protect the drug from light, FILAB measures spectral transmission between 290 and 450 nm using a UV-Vis spectrophotometer suitable for the analysis of plastic materials. The results are compared with the criteria in Table 2 of USP 661-2, adjusted according to the nominal volume and route of administration.
Our technical capabilities for analysis according to USP 661-2
To provide you with reliable analyses and interpretations, FILAB has a comprehensive analytical platform suited to analysis. This includes in particular:
- the GC-MS, HPLC or UHPLC/MS/MS for the detection, 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
- the ICP-AES and ICP-MS particularly suited to mineral or metallic contaminants or additives, such as heavy metals, mineral or metallic fillers, colorants…
- microscopy SEM-EDX, a truly rapid and versatile diagnostic tool for assessing the material surface condition after aging, and for observing particles, deposits…
For the pharmaceutical sector, the FILAB laboratory follows the ICH Q3E guideline.
- Identification of extractables according to USP <1663>
- Evaluation of leachables according to USP <1664>
- Extractables & Leachables analysis according to BPOG (Good Operating Practices)
- Analysis of plastic material components according to USP <661.1>
- Analysis of process material leachables 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
Analysis of the purity of additives
Why choose FILAB for your analyses according to ISO 661-2?
- COFRAC ISO 17025 accreditation and GMP environment
Guarantees technical expertise, the traceability of our measurements, and the enforceability of our analytical results with French and European regulatory authorities, as well as the U.S. FDA. - Comprehensive multi-technique analytical platform
- Mastery of regulatory thresholds (AET, SCT, etc.)
- Structured reports for your regulatory submissions
Each FILAB report is structured for direct integration into your submissions: CTD Module 3, IMPD, STED, BER, 510(k) or PMA dossier. Our deliverables include detailed operating conditions, annotated chromatograms, identification/quantification tables, and toxicological assessment of the detected compounds.
Our FAQ
USP <661.1> applies to plastic materials tested individually such as pellets, films, or polymer parts.
- USP <661.2> applies to the complete packaging system (bottle, bag, syringe with its closure) in direct contact with the finished drug product.
These two approaches are recognized by the USP as equivalent for demonstrating the compliance of a pharmaceutical packaging system.
No, these are two alternative pathways.
The requirements of USP <661.1> are considered met if the materials are used in a packaging system that already meets the requirements of USP <661.2>.
The protocol is tiered according to the system’s thermal resistance:
121°C for 30 min (standard autoclave condition).
100°C for 2 h if the system cannot withstand 121°C.
70°C for 24 h if the system cannot withstand 100°C.
50°C for 72 h for the most heat-sensitive systems (official new update from December 2025).
USP <661.2> requires a risk-based chemical suitability assessment for all dosage forms.
For high-risk dosage forms (injectables, inhaled products), comprehensive studies according to USP <1663> and USP <1664> chapters are generally expected by regulatory authorities.
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, any 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.
However, FILAB is committed to providing fast turnaround times adapted to your constraints and industrial urgencies.
