Exploring Extractables and Leachables Analysis

Extractables and leachables are contaminants or impurities that are produced in pharmaceutical processes like manufacturing process, container closure system and packing material of drug products which affects directly on their purity and efficacy. Extractables and leachables testing is critical to identify and quantify of the theoretically harmful impurities. These impurities can migrate from pharmaceutical container closure systems to contaminate a drug product and then it may become a risk to a patient’s health and drug product’s quality issues.

According to The FDA the two terms are defined as follows:

• Extractables are compounds that can be extracted from the container closure system when in the presence of a solvent.
• Leachables are compounds that leach into the drug product formulation from the container closure system as a result of direct contact with the formulation.

In May 1999, the U.S. FDA published a guidance document on Container Closure Systems for Packaging Human Drugs and Biologics. The FDA mandated that pharmaceutical manufacturers demonstrate the safety of materials used in manufacturing or production systems, container closure systems or drug delivery devices. Failure to establish material safety could result in failure to receive FDA approval for a product. A new guideline on the assessment and control of extractables and leachables (E&L) is proposed. ICH guidelines covering many aspects of impurities.

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).