The USP <661.2> monograph will come into effect on December 1, 2025, discover what it requires and how to comply with the physical-chemical, biological, and extractables & leachables (E&L) tests for pharmaceutical plastic packaging
On December 1, 2025, the USP <661.2> monograph “Plastic Packaging Systems for Pharmaceutical Use” will take effect, introducing new requirements to ensure the safety, compatibility, and quality of plastic packaging materials used in pharmaceutical products.
This update represents a significant change for laboratories, manufacturers, and suppliers in the sector, who will need to demonstrate the chemical and biological suitability of their packaging systems in accordance with the tests required by the standard.
Effective Date and Purpose of the USP <661.2> Monograph
The United States Pharmacopeia (USP) has revised its chapters dedicated to plastic materials in order to establish more rigorous and harmonized criteria.
The purpose of the USP <661.2> monograph is to ensure that plastic materials in contact with pharmaceutical products do not affect their quality, safety, or efficacy, preventing the migration of potentially toxic substances or any chemical interaction between the packaging and the product.
Starting in December 2025, all plastic primary packaging systems must comply with this monograph, demonstrating that they are chemically and biologically suitable for their intended use.
What Does USP <661.2> Require?
USP <661.2> establishes that manufacturers must assess the composition, properties, and performance of the plastic materials used in pharmaceutical packaging.
The main requirements include:
- Chemical suitability: Demonstrating that the packaging does not release compounds that could alter the medicinal product.
- Biological suitability: Verifying that the material does not exhibit cytotoxicity or any adverse biological reactivity.
- Comprehensive evaluation of the packaging system: Assessing not only the base material but also all components such as closures, liners, valves, and other parts.
In addition, USP <661.2> complements other regulations such as USP <661.1> (Plastic Materials of Construction) and aligns with international guidelines on material quality and purity, such as ICH Q3D.
Tests Required to Demonstrate Compliance
To ensure compliance with USP <661.2> for pharmaceutical plastic packaging, a series of physicochemical and biological tests must be performed.
Physicochemical tests:
- UV absorbance
- Acidity / alkalinity
- Total Organic Carbon (TOC)
- Solution appearance
- Terephthalate moieties
- Ethylene glycol
- Transmittance
Extractables and Leachables (E&L) studies:
Extractables and Leachables (E&L) studies are essential to identify potential compounds that may migrate from the packaging into the product. These studies help assess the risk of chemical contamination and ensure that levels remain within acceptable limits.
In vitro biological reactivity tests:
Determination of the biological compatibility of the material, ensuring that it does not cause adverse effects on cells or tissues.
Each of these tests contributes to demonstrating the safety, purity, and compatibility of the packaging in accordance with the criteria established by USP <661.2>.
How to Comply with USP <661.2>
At Netpharmalab, we have the expertise, equipment, and accreditations required to help you comply with the USP <661.2> monograph and other international regulations applicable to pharmaceutical packaging.
Our laboratories specialize in performing all the tests described in USP <661.2>, including:
- Extractables & Leachables (E&L) studies
- Physicochemical and transmittance tests
- In vitro biological reactivity assays
In addition, our technical teams and consultants can provide guidance in the planning and documentation of studies, ensuring that each packaging system meets regulatory requirements before the effective date.
Our mission is to be your technical and regulatory partner, offering precise solutions tailored to each type of packaging or formulation.
Ensure Your Packaging Compliance Before December 2025
The implementation of USP <661.2> marks a new standard in the evaluation of pharmaceutical plastic packaging, aimed at strengthening patient safety and product quality. Complying with its requirements is not only a regulatory obligation, but also a mark of trust and quality for auditors and health authorities.
At Netpharmalab, we provide a specialized team to ensure the regulatory compliance of your plastic packaging systems — from the initial assessment to the delivery of the final compliance report.
Contact us to receive personalized guidance or request a quotation for your USP <661.2> compliance studies.
