Biological Purity | Potency Assays

Biological Purity | Potency Assays

purity and potency assays
Biological purity and potency assays are procedures used by laboratories studying medicine, pharmacology, or other biological process, to assess or measure the presence of a substance.

Biological purity and potency assays are procedures used by laboratories studying medicine, pharmacology, or other biological process, to assess or measure the presence of a substance, referred to as an analyte, whether it be a drug, a cell, or another organism. The analyte is the target of the study.

Potency assays are most often used to measure a drug’s ability to produce a certain effect at a certain dose. Most regulatory agencies require potency assays be performed before a drug product is released. There are two types of potency assays, ligand-binding that measure the interactions of a drug product with it’s target, and functional assays, that measure the biological response.

Purity testing measures the amount of impurities present in a sample and is expressed as either a fraction or as a percentage. If the sample has low purity, this means it has many contaminants. If the purity is high, there are few contaminants.

If you are looking for a laboratory to perform purity and potency assays, call us at 1-855-377-6821, or visit us online to submit a test request! Below are some of the purity and potency test requests we have received and helped facilitate:

  • Bioanalytical laboratory needed for quality control testing of reference materials, including identification and purity assay by HPLC, LCMS, IR, UV-Vis, NMR, Polarimetry
  • Life Science Research facility needs bioanalytical laboratory to do peptide identification and purity assays.
  • Analytical chemistry laboratory needed for sodium phytate testing: verification testing of purity assay of sodium phytate is really what the certificate of analysis says. We would like to have the assay % tested using the “Quimociac Gravimetric Method” since this is the same method the supplier uses. Please let me know if your lab is able to perform this testing, how much sample would be needed, turnaround times, cost of analysis
  • Europe pharma needs bioanalytical laboratory for potency assay testing of human growth hormone
  • FDA GLP Bioanalytical Laboratory needed for Ph Eur Potency assay for hepatitis A antigen in compliance with Ph Eur 2.7.14 and General Safety as in 21CFR610
  • USA GLP Preclinical Contract Research Organization needed for Erythropoietin bioassay-Establish the specific activity of a erythropietin batch. Also interested in in vivo potency assay. We would like to outsource this test for future clinical trials.
  • plus more!