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Extractables and Leachables Support for Pharmaceutical Products

ExtLe Solutions Limited provides Extractables and Leachables support, to the API / drug product development process. Depending on the requirements of our clients, the studies we design align with appropriate regulatory guidance documents, including but not limited to 

  • USP <1663> - Assessment of Extractables Associated with Pharmaceutical Packaging / Delivery Systems

  • USP <1664> - Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Delivery Systems

  • USP <1664.1> - Assessment of leachables in OINDPs

  • PQRI guidance - Safety Thresholds & Best Practices for Extractables & Leachables in OINDPs

  • BioPhorum Operations Group (BPOG) Best Practices Guides 

Select the type of support you require from the options below

We support the following drug product device types

  • DPIs & MDIs

  • Intranasal pumps

  • SVPs & LVPs 

  • Pre-filled syringes 

  • Autoinjectors

  • Opthalmics

  • Topicals

  • Transdermals

  • Blow fill seal nebules

We support single use system (SUS) components including

  • Manufacturing / mixing / storage bags

  • Disposable process filters

  • Diafiltration / ultrafiltration membranes and cassettes  

  • Transfer / filling lines

  • Connectors

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