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At Neopharm, we offer comprehensive extractables and leachables studies to assess the potential migration of substances from biomedical devices, packaging components, and manufacturing components. Our studies follow USP guidelines to ensure regulatory compliance and the safety of your products. With a wide range of analytical techniques and advanced databases, we provide thorough analysis, interpretation, and confirmation of extractables and leachables. Count on our expertise to support your product development and meet regulatory requirements.
The Analytical Evaluation Thresholds (AET) of the Safety Concern Threshold (SCT) and the Qualification Threshold (QT) are calculated for your specific finished product based on the Threshold of Toxicological Concern (TTC) using Maximum Daily Dosage (MDD) and labeled dose/container.
We test the container closure system, manufacturing component or medical device with one or more extraction types (ex., Accelerated product use, aggressive conditions, etc.) using an extraction medium stressed under specific conditions (temperature and time).
We discuss the protocols with our clients to document the results according to the type of extraction chosen.
Our data interpretation services give you an in-depth look at your product. you will be able to take the necessary steps to ensure product safety and quality.
We analyze and report the results within the limits of the method; for each substance detected above the AEET at SCT. We determine tentative structures using commercially available databases and an in-house library and confirm these structures with standards when available.
Neopharm offers direct extractable-leachables correlation as well as accelerated product use for better understanding of the product's stability over time. Our monitoring system keeps track of all changes in your product's stability during a stability study, giving you peace of mind.
We use a range of advanced analytical techniques, including gas mass spectrometry coupled to chromatography (GC/MS), liquid chromatography (LC/MS) and inductively coupled plasma (ICP-MS). These techniques enable us to identify, quantify, and characterize a wide range of extractables and leachables. Our state-of-the-art mass profile software and extensive databases support accurate interpretation and confirmation of the results.
Yes, we have a comprehensive NIST database with over 243,000 molecules for the interpretation of GC/MS results. Additionally, we maintain a complete database with more than 1,000 potential leachables for the interpretation of LC/MS (QTOF) results. These databases enhance our ability to identify and characterize extractables and leachables, ensuring accurate analysis and reliable results.
We confirm the tentative structures identified during extractables and leachables analysis by using real standards. Our extensive library of reference standards allows us to compare and verify the identified substances, ensuring the accuracy of the results. This confirmation process provides further confidence in the characterization and safety assessment of extractables and leachables.
Absolutely. We conduct materials of construction characterization in accordance with USP guidelines. By evaluating the compatibility of materials used in your pharmaceutical products, we help ensure their suitability and minimize the potential for extractables and leachables. Our expertise in materials characterization supports the overall safety and quality of your products.
For comprehensive extractables and leachables studies that meet regulatory requirements and ensure the safety of your pharmaceutical products, partner with Neopharm. Contact us today to discuss your specific needs and leverage our expertise in extractables and leachables assessment.Contact us