Testing related to extractables and leachables
To ensure patient’s safety, the FDA requires all Drugs to be qualified to ensure that no chemicals transfer into the drug from its packaging or production. Such an analysis is called Extractables and Leachables Testing.
1. We at Chromak research provide services of testing extractables and leachables using various instruments including ICP-MS, GC-MS, LC-MS to quantify toxicological impurities at low level or concentration. .
2. We apply standard methods to identify and quantify of unknown organic and elemental impurities. We can also develop and validate new methods as per client’s needs. Our scientists also perform chemical testing of E&L impurities at Chromak Research e.g., pH, Conductivity, Total Organic Carbon etc.
3. Our well experienced team can conduct E&L (Extractables and leachables) analysis or testing in accordance with regional guidance and nationally or internationally recognized standards including GMP, USP guidance for E&L (USP chapters <665>, <1665>, <1663>, <1664>, and <1664.1>), European Medicines Agency (EMA) guidance, US Food and Drug Administration, FDA extractables and leachables guidance, Product Quality Research Institute (PQRI) extractables and leachables guidelines and ISO 10993-18 extractables and leachables guidelines (Part 18).