Biorelevant Dissolution Filters

  • Designed for both fasted and fed state biorelevant dissolution media

  • High filtration efficiency with minimal risk of clogging or bursting

  • Low drug adsorption and negligible extractables

  • Built-in prefilter facilitates filtration and reduces risk of bursting

  • Glass Microfibre (GMF) 13mm or 25mm filter diameter available

  • Easy to handle 25mm casing for both filter diameters

  • Custom-made in the UK to Biorelevant's exact specifications

  • Certificate of Conformity available

Background

Using the right filter for dissolution sampling can make a big difference to your biorelevant results. When carrying out dissolution runs, samples taken from each vessel at the defined time points must be filtered punctually to remove any undissolved (solid) drug to terminate the dissolution process immediately.

                                          

A suitable filter for dissolution should be efficient, reproducible, have low drug adsorption and not leach extractables, clog or burst. A 0.45µm pore size is generally best for testing drugs with biorelevant media in standard USP vessels.

Which filter diameter should I use?

Biorelevant's dissolution filters are available in two diameters: 13mm and 25mm. Low volume sampling is recommended to keep the amount of medium in the dissolution vessel at a high and consistent volume which is why we recommend the use of the 13mm diameter filter. However, if you prefer to take larger sample volumes (>5mL) then a 25mm diameter filter is also available.

The importance of fresh filters

For optimal dissolution results, we strongly recommend using a fresh filter at each sampling time point to halt the dissolution process. This is why our filters are available in boxes of 72 pieces.

Certificate of Conformity

We have developed our dissolution filters in conjunction with Cytiva who manufacture them for us in the UK. Each batch comes with a Certificate of Conformity; they have a good flow rate, low hold up volume, low retention and should not clog, even when sampling high dose insoluble drugs.

GUIDES

Two Stage Biorelevant Dissolution Filter Adsorption Study

Determine the % of drug adsorption and required volumes of media for dissolution sampling 

MaterialDrug Substance
MediaFaSSGF and FaSSIF
FilterGMF 13mm 0.45μm
AnalysisHPLC
FEDGAS Filter Adsorption Study

Determine the % of drug adsorption and required volumes of media for dissolution sampling 

MaterialDrug Substance
MediaFEDGAS (Early/Mid/Late)
FilterGMF 13mm 0.45μm
AnalysisHPLC

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  • For filtration of dissolution samples <5mL we recommend 13mm

  • For filtration of dissolution samples >5mL we recommend 25mm

BRL Disso Filters (13mm)
GMF13
72 pieces
BRL Disso Filters (25mm)
GMF25
72 pieces
In stock
$199.99
Buy 4, Save 25%
- +
In stock
$199.99
Buy 4, Save 25%
- +