Integrated Solutions for Extractable and Leachable

Studies of extractable and leachable components within packaging systems and closures have become mandatory requirement to meet the safety requirements for marketed medicines. This area of growing regulatory significance provides many challenges in the development and analysis of Extractable and leachable for inhalation, ophthalmic and injectable drug products. In order to obtain successful regulatory approval for new drug applications, packaging interactions with the drug product should be evaluated to ensure product safety.
According to USFDA cosmetic Act section 501 (a)(3)“A drug is deemed to be adulterated if its container is composed in whole or part of any poisonous or deleterious substance which may render the contents injurious to health”. The webinar outlines about FDA risk analysis, FDA’s Quality control approach and factors to be considered during studies of Extractable and Leachable.
Development and Evaluation studies of E & L includes Evaluation of packaging material COA, solvent extraction studies using varying polarity solvents, Identification and Quantification on LC-MS and GC-MS, Identification of Toxic and geno-toxic compounds, Toxicity evaluation as per Derek Nexus software, validation of developed analytical methods and leachable study during shelf life of product.
“To obtain the successful regulatory approval and to understand what Extractable and Leachable is, add this webinar to your calendar’’