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GEL Analytics provides a variety of Non-GLP discovery phase services designed to meet the unique requirements of drug discovery projects. We focus on quick turnaround times to meet the short time frame requirements that are often present. Non GLP studies are usually performed using acetonitrile protein precipitation methods because they are simple, efficient and quick.
Listed below are the discovery phase services that we provide:
Level I Analyses
- Data is submitted electronically within two working days.
- Includes the preparation and analysis of a blank, a zero and eight calibration points.
- Calibrations are typically performed from 10 ng/mL to 2,500 ng/mL in the matrix being analyzed.
- The acceptance criterion for the calibration is to have back calculated results for each calibration point within 25% of the nominal concentration.
- The Lower Limit of Quantitation (LLOQ) analyses is the lowest calibration concentration that is used.
- A technical review of the data is performed before reporting the electronic data.
Level II Analyses
- Data is submitted electronically within two working days.
- Two calibration curves are prepared and analyzed. Curves are analyzed prior to sample analysis and immediately following sample analysis. Each curve includes a blank, a zero sample and eight calibration points. The two curves are combined and used for quantitation.
- Calibrations are typically performed from 10 ng/mL to 2,500 ng/mL in the matrix being analyzed.
- The acceptance criteria for the calibrations is that the back calibrated values for the calibration points are within 25% of the nominal value and the r value for the combined curves is greater than or equal to 0.94.
- The LLOQ for Level I analyses is the lowest calibration concentration that is used.
- A technical review of the data is performed before reporting the electronic data.
Level III Analyses
- Data is submitted electronically within ten working days.
- Quality Control (QC) samples are prepared and analyzed. A total of six QC samples are prepared, two each at a low concentration, midrange and high concentration.
- Acceptance for the batch QC is the requirement that four of the six QC results are within 25% of the nominal spiking concentration. The QC samples are spiked with a standard that was prepared in a separate weighing from that used to prepare the calibration standards. Any results that are above the highest concentration, regardless of calibration model, are diluted and reanalyzed. In the event that a dilution is necessary, two QC samples at the higher concentration are prepared and analyzed with the diluted sample. At least one of the two QC must be within 25% of the spiked concentration.
- Data receives a technical review and QC review before release to the client.
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