In the biopharmaceutical industry, it’s important to identify extractables and leachables for patient safety and submissions to regulatory authorities. Impurities can originate from process components, manufacturing equipment, packaging materials, and container closure systems used in the development of a drug product. Extractable and leachables (E&L) studies detect and identify the organic and inorganic compounds that may be inadvertently released into the product.
Rapidly Identify Polymer Additives in E&L Screenings
Many of the impurities and substances reported are additives to the polymer formulations of the packaging and container closure systems that provide a variety of technical effects to the polymer formulations. These analytes include low molecular weight oligomers, additives, catalysts, mold release agents, dyes and colorants, plasticizers, antioxidants, and stabilizers. Certain extractable and leachable compounds can interact with drug products, compromising safety and efficacy.
Unlike GC/GC-MS analysis, there is a lack of HPLC/LC-MS libraries available in the market for the identification of extractables and leachables. In order to facilitate the rapid identification of polymer additives in E&L screenings, Avomeen’s extractables and leachables scientists have developed a proprietary polymer additive library of over 120 prevalent polymer additive compounds observed during the analysis of everyday products.
Data for Seven Major Categories of Polymer Additives Compiled
To facilitate the identification of extractables, we have acquired and compiled data on hundreds of examples across seven major categories of polymer additives including:
- Bisphenol analogues
- UV stabilizers
Samples were diluted to 100ppm in suitable solvents for analysis with HPLC, and to 10ppm for analysis with LC-MS and GC-MS.
Your Regulatory Submission Can Benefit from Avomeen’s Polymer Additive Library
Extracts will be analyzed using the same HPLC conditions, and HPLC chromatograms (retention time and absorption) and LC-MS patterns will be compared to the results generated in the library for the best match and identification.
Extractable and leachable testing is critical for the pharmaceutical and medical device industries where packaging safety and toxicology studies are required for product registration. Our regulatory and industry experts can guide you through the process to access and profile your products’ extractables and leachables while meeting FDA regulations. Do you have a specific project in mind? Get in touch with a scientist.
Looking for more information about our proprietary polymer additives database? Check out our Development of a Library of Plastic Additives for Identification of Extractables Poster Presentation.
The FDA Gets Stricter with E&L Oversight, Can the Industry Keep Up? article in Contract Pharma, featuring Dr. Andrew Kolbert, Avomeen’s CTO, offers valuable insight.
In our years supporting the biopharma industry, we’ve seen some common mistakes made in E&L study design. We’ve outlined what not to do in our blog, Common Pitfalls in Ectractables & Leachables Testing.
Looking for a summary of USP guidelines for E&L testing? Our blog, The Long and Short of USP Guidelines for E&L Testing, offers some guidance.
Our blog, The Growing Need for Extractables & Leachables Testing of Pharmaceutical Manufacturing Equipment, offers information about FDA oversight and how CROs can help companies navigate the E&L process.
Learn more about FDA’s increasing oversight of E&L testing in pharma in Dr. Kolbert’s article in Tablets & Capsules Magazine.