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Aqueous Solubility

We use our patented automated platform to measure both true (thermodynamic) and kinetic (with auxiliary solvents) solubilities vs. pH. Solubility is measured directly from its definition, avoiding costly errors and ambiguous interpretations.

Our unique approach allows you to test more compounds or test the same compounds at multiple pH. You no longer need to pick and choose which compounds to test due to the high price per assay charged by other CRO. Don’t leave your next blockbuster drug in the compound bank; test it today.

Archival quality data

  • True solubility, not an approximation

Large dynamic range

  • Below µg/mL to high mg/mL

Flexible

  • Dry and DMSO-dissolved compounds
  • Multiple pH: 2.0, 4.5, 6.6, 7.4, 8.5, and 11.0
    • Early screening: Test many compounds at one pH
    • Lead optimization: Test a few compounds at multiple pH

Universal method of detection

  • Compound structure is not needed
    • We need to know only the number of nitrogens and molecular weight

Highest level of accuracy and repeatability

  • Routine complete calibration
  • Real-time monitoring of all the system’s critical performance parameters
  • Assays performed with an on-board set of standards

Extensive validation

  • Demonstrated excellent correlation to manual shake-flask data using hundreds of compounds


Solubility Quick Facts

Assay: Aqueous Solubility

Method: Automated, miniaturized gold standard shake-flask method, incubation per client protocol, filtration, followed by total equimolar chemiluminescent nitrogen detection

Experience: Developer of Automated ADME technologies since 1999 with tens of thousands of data points for clients ranging from large pharma to small biotechs

LOD: 0.1µg/mL min, max limited by amount of available materials (nominal, actual compound-specific limits are determined by compound amount, molecular weight, and number of nitrogen atoms in each compound)

Accuracy: Linear fit between automated manual shake-flask and literature data demonstrated fit with r2 = 0.9993

Precision: Typically CV < 3%

Failure Rate: 0.3-0.7% based on over 12,000 data points

Source: Dry Powder or DMSO dissolved compounds in 96 well plates, typically 10µL (less when ordered with additional assays), 30mM concentration

Turnaround time: As little as 24 hours, typically within 5 business days

Results: Provided electronically. Tabulated data in Excel per customer instructions. All results are analyst-checked; internal standards are included on each plate.

NEWS & EVENTS

MARM 2008

MOVE/EXPANSION COMPLETED!!

6th EGA Symposium on Biosimilar Medicines
London April 24th - 25th

AAPS
November 16-20, 2008

BioProcess International
September 23 - 26, 2008

Analiza major sponsor for new APS Pharmaceutical Poster website

Biosimilars 2007
12/6-12/7

Talk #1 - New and established analytical tools for demonstrating comparability
Talk #2 - Low-Cost Process Purification Technology For Enabling Competitive Biosimilars

AnalizaDx receives 2007 Innovation Award
11/14/07

Analiza presenting three posters at the upcoming AAPS conference
11/11-15/07

AAPS
11/11-15/07

In Vitro ADME Techniques and Assays
9/27/07

Screening and Ion Channel Targets
9/10-11/07

International Conference on Biopartitioning and Purification
6/17-20/07

Genetic Engineering News
6/15/07

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