USP Pre Filled Syringe Leachables Testing
The USP Pre Filled Syringe Leachables Testing is a critical component of pharmaceutical testing, particularly for injectable and parenteral products. This service ensures that leachable substances from the syringe do not adversely affect the product or patient safety. The process involves a series of meticulous steps to assess the potential contaminants that may leach into the solution within the pre-filled syringe.
The USP (United States Pharmacopeial Convention) guidelines provide stringent criteria for testing, ensuring that the materials used in pharmaceutical packaging and containers are safe and do not interact with the product in a harmful way. Leachables can include various compounds such as plasticizers, antioxidants, stabilizers, and other substances from the container or stopper.
The testing process begins with the selection of appropriate leachable standards and solvents based on the composition of the pre-filled syringe. Common solvents used in this testing are water, aqueous phosphate buffer (PB), 0.1 M sodium hydroxide (NaOH) solution, 0.1 M acetic acid (CH3COOH) solution, methanol, and ethanol.
The sample preparation involves disintegration of the syringe under controlled conditions to simulate real-world use scenarios. The extractant is then applied to the disintegrated material for a specified duration before it is filtered and analyzed using high-performance liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), or inductively coupled plasma mass spectrometry (ICP-MS).
The analytical techniques employed ensure accurate quantification of leachable substances, providing data that can be compared against the USP monographs for safety and compatibility. This service is particularly important for ensuring regulatory compliance with various standards including USP General Chapter 3.
The results of the testing are detailed in a comprehensive report, which includes the identification and quantification of leachable compounds. This information is vital for manufacturers to make informed decisions about raw material selection and packaging design.
Applied Standards | Description |
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USP General Chapter Leachables and Extractables | Provides guidelines for the identification, quantification, and control of leachable substances from pharmaceutical containers. |
ISO 10993-18:2017 | Describes biological evaluation methods for medical devices. |
Applied Standards
Applied Standards | Description |
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USP General Chapter Leachables and Extractables | This chapter outlines the methodologies for determining leachable substances from containers, closures, and other contact materials used in drug products. |
ASTM D2369-07(2015) | Describes a test method for determining extractables from plastic materials using various solvents. |
Eurolab Advantages
EuroLab offers unparalleled expertise and state-of-the-art facilities dedicated to pharmaceutical testing. Our team of experienced scientists and engineers is committed to delivering accurate, reliable, and compliant results that exceed your expectations.
- Comprehensive understanding of USP guidelines for leachables and extractables testing
- Use of advanced analytical techniques including HPLC, GC-MS, and ICP-MS
- Experience in handling a wide range of pharmaceutical products
- Dedicated resources for method development and validation
- Compliance with international standards and regulatory requirements
We provide not only the testing service but also consultative support to help you navigate complex regulatory landscapes. Our commitment to quality ensures that your products meet the highest safety and efficacy standards.
International Acceptance and Recognition
- The USP General Chapter Leachables and Extractables is internationally recognized, including by the European Medicines Agency (EMA) and the World Health Organization (WHO).
- ASTM D2369-07(2015) is widely accepted in the pharmaceutical industry for extractable testing.
- The results of USP leachables testing are often used as a basis for international regulatory submissions, enhancing your product’s global acceptance.
EuroLab ensures that all our testing aligns with these internationally recognized standards, providing you with data that is accepted worldwide.