From LEAP
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| | + | Reaction mixtures are prepared and then incubated at 4 different temperatures. Over a period of time, samples are taken from each batch and injected to the HPLC to determine analyte stability. |
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| - | A technician will load drug stock solution into eight 10ml vials. Then the technician will load reagent solution into eight 10ml vials. These vials will be loaded into the first 16 positions of a 32-position tray. This tray will be placed onto a cooling tray holder that will keep the vials at a temperature of 5 degrees Celsius. Eight empty 10ml vials will be placed in positions 17 thru 24 in the VT32 tray. These 10ml vials will be used to mix together the drug stock, the reagent solution and the solvent.
| + | Time intervals are determined in theMethod. Batches can run from just a few hours to several days. |
| - | 96-position destination plates will be placed into four coolstacks that will be kept at temperatures of 5 degrees Celsius, 25 degrees Celsius, 40 degrees Celsius and 60 degrees Celsius.
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| - | Once all of the trays are loaded into the PAL, drug stock solution will be added to a mixing vial. Then reagent solution will be added to the same mixing vial. Then 1 of 4 solvents will be dispensed through the dilutor to the same mixing vial.
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| - | The 10ml vial will then be transported to the agitator where it will be agitated for 10 minutes at a speed of 500 rpms and a temperature of 50 degrees Celsius. Once the incubation period expires, a sample will be collected from the mixing vial and transferred to a well of the 96-position destination tray in the coolstack kept at 5 degrees Celsius. Another sample will be collected from the mixing vial and transferred to a well of the 96-position destination tray in the coolstack kept at 25 degrees Celsius. Another sample will be collected from the mixing vial and transferred to a well of the 96-position destination tray in the coolstack kept at 40 degrees Celsius. Another sample will be collected from the mixing vial and transferred to a well of a 96-position destination tray in the coolstack kept at 60 degrees Celsius.
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| - | Each batch will contain 8 samples. Once all of these samples have been completely prepped, these samples will sit in the coolstacks for a period of time determined by the operator. This period of time may last up to 12 hours. After this time period expires, 10ul to 30ul of sample will be collected from each of the 8 batch samples and injected into the LC valve. This process will be repeated 5 more times. Each of the time intervals between these injections will be determined by the operator. The maximum amount of time that could last for an entire batch run is just over 72 hours.
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Current revision
Reaction mixtures are prepared and then incubated at 4 different temperatures. Over a period of time, samples are taken from each batch and injected to the HPLC to determine analyte stability.
Time intervals are determined in theMethod. Batches can run from just a few hours to several days.
