• There are no suggestions because the search field is empty.

Your Cart

Checkout
Home

Biotage® Extrahera™ GLP software and 21 CFR part 11 regulations

By Biotage

Clinical, forensic and doping testing Technical note

The Biotage® Extrahera™ GLP Software is designed to automate sample preparation in many applications that utilize solid-phase extraction (SPE), supported liquid extraction (SLE), dual mode extraction (DME), phospholipid depletion (PLD), protein precipitation (PPT) and filtration techniques. 

Compliance with 21 CFR Part 11 involves both technical (i.e. hardware and software) and procedural requirements. This technical note explains how Biotage® Extrahera™ contributes to fulfilling the technical requirements of 21 CFR Part 11.10: Controls for closed systems.

Literature number: PPS628

Related literature

2025.12.06

Work-up of basic products from organic synthesis mixtures using ISOLUTE® SCX-2

ISOLUTE® SCX-2 is used for the work-up of basic products from organic synthesis mixtures containing non-basic reagents or by-products.

2025.12.06

General approach to the extraction of basic drugs from biological fluids using non-polar ISOLUTE® SPE cartridges

This technical note describes the extraction of basic drugs from biological fluids using non-polar ISOLUTE® SPE cartridges.

2025.12.11

Sample preparation by mixed-mode SPE using ISOLUTE® HAX

This technical note describes the extraction of acidic drugs from biological fluids using ISOLUTE® HAX mixed-mode SPE products.