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PHARMACEUTICAL DEVELOPMENT AND COMPATIBILITY …
Leachables are Chemical compounds, typically a subset of extractables that migrate into a drug formulation from any product contact material as a result of direct contact under normal process conditions or accelerated storage conditions. These are likely to be found in the
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1664 〉〉〉〉 ASSESSMENT OF DRUG PRODUCT …
latam-edu.usp.orgExtractables themselves, or substances derived from extractables, have the potential to leach into a drug product under normal conditions of storage and use and become leachables. Thus extractables are potential leachables. Leachables are foreign organic and inorganic chemical entities that are present in a packaged drug product because they have
Safety Thresholds and Best Demonstrated Practices for ...
pqri.orgIn 1999 the PQRI Leachables and Extractables (L&E) Working Group was established with the goal of reducing leachable uncertainty in Orally Inhaled or Nasal Drug Products (OINDP) using a science and risked based approach.
United State Pharmacopeia Particle Determination: …
www.pharmout.netExtractables USP <1664> Leachables USP <1665> Toxicological Assessment USP <661.1> Materials USP <661.2> Packaging <87> Biological Reactivity In Vitro <88> Biological Reactivity In Vivo <661.3> Plastic Components and Systems Used to Manufacturer Pharmaceutical Drug Product Objective 1. To provide tests and specifications for the characterization of