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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
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USP <1663> - Assessment of Extractables Associated with Pharmaceutical Packaging / Delivery Systems
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USP <1664> - Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging Delivery Systems
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USP <1664.1> - Assessment of leachables in OINDPs
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PQRI guidance - Safety Thresholds & Best Practices for Extractables & Leachables in OINDPs
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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
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DPIs & MDIs
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Intranasal pumps
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SVPs & LVPs
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Pre-filled syringes
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Autoinjectors
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Opthalmics
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Topicals
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Transdermals
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Blow fill seal nebules
We support single use system (SUS) components including
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Manufacturing / mixing / storage bags
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Disposable process filters
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Diafiltration / ultrafiltration membranes and cassettes
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Transfer / filling lines
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Connectors