Serving Scientists Since 1994

Dabigatran Etexilate Mesylate Baskets

Dabigatran Etexilate Mesylate Baskets

Dabigatran Etexilate Mesylate (DEM)  requires the use of a special wider basket for dissolution testing. This method can be referenced by searching the FDA database here

http://www.accessdata.fda.gov/scripts/cder/dissolution/

This basket was originally developed by Labhut for this application in conjunction with the drug manufacturer.

The basket is wider than the standard USP basket and therefore it will not fit on to a standard USP1 basket hub and a special hub/basket shaft must be used. These are available for a number of different baths listed below.  If your bath is not listed then please contact use with details of your bath for help. (The diameter and length of your current basket shafts will also be required).

 

Validation.

After switching to this basket it is recommended perform the standard height, centering and wobble test on the basket. The acceptable limits are the same for these baskets as they are for standard USP1 baskets.

 

Dissolution Testers Supported

Agilent

A spin on/off basket shaft is available for Models 708/709.

 

Distek

All Distek models are supported.

For the testers using the solid shafts (without thermistors inside) we recommend changing the basket and shaft. 

For the testers that have thermistors inside the shaft, the hub can be replaced on its own. This screws on to the bottom of the shaft in the same way as the standard Distek hub.

 

Erweka

Some Erweka baths are supported. Please contact us with details of your bath model. In particular we would need to know the bath model and the current length of the basket shaft

 

Hanson Research

Both the Hanson SR8 and Hanson Vision Elite are supported. The SR8 requires the whole basket shaft, the Vision Elite requires the lower spin shaft.

 

Sotax  

The AT7 can use a basket hub screws on in place of the standard hub and allows the sample to be taken through the hollow shafts.

 

Vankel/Varian

The hubs are available for the most vankel units.

19” shafts can be supplied designed to fit the older V7000/7010 series

 There is a 15” one piece shaft that can be used with the Vankel V series. Spin on/off shafts are also available for those baths that use them

 

Other bath types

Please contact us. We would need to know the length of your current basket shaft, the diameter and if possible a picture.