ABC Laboratories draws on 40 years of analytical expertise identifying and quantifying test substances in soil, water, complex media and biological tissues to deliver a complete package of environmental assessment tests to our pharmaceutical customers. ABC offers the full array of required product chemistry, ecotoxicology, environmental fate and metabolism studies. ABC also performs radiolabeling synthesis to support specific study requirements. Our laboratories are well-equipped with the latest mass spectrometry instrumentation to ensure highly sensitive, robust methods and rapid, reliable test results.
The U.S. Food and Drug Administration (FDA) requires that an environmental assessment accompany any New Drug Application (NDA) or Animal NDA for a drug with an expected environmental concentration greater than one part per billion (ppb), as well as those known to cause adverse ecotoxicological effects at lower concentrations. Through established relationships with consulting firms specializing in NDA/NADA risk assessments and registration submissions, ABC will guide our customers through regulatory requirements and prepare the necessary EA summary report for submission to the FDA. Additionally, ABC conducts environmental risk assessments under European regulatory guidelines.
Physical-Chemical Properties
- 3.01 Water Solubility / OECD 105
- 3.02 n-Octanol/Water Partition / OECD 107
- 3.03 Vapor Pressure / OECD 104
- 3.04 Dissociation Constant / OECD 112
- 3.05 Ultraviolet-Visible Adsorption Spectrum / 101
- 3.06 Melting Temperature / OECD 102
- 3.07 Density and Relative Density / OECD 109
Environmental Fate
- 3.08 Sorption/Desorption / OECD 106
- 3.09 Hydrolysis / OECD 111
- 3.10 Photodegradation in Water
- 3.11 Aerobic Biodegradation in Water / OECD 301 and 302 Series
- 3.12 Aerobic Biodegradation in Soil / OECD 307 or OECD 308
Environmental Effects
- 4.01 Algal Toxicity / OECD 201
- 4.02 Microbial Growth Inhibition / OECD 209 Activated Sludge Respiration Inhibition
- 4.06 Seed Germination & Root Elongation / OECD 208
- 4.07 Seedling Growth / OECD 206
- 4.08 Daphnia magna Acute Eoxicity / OECD 202
- 4.09 Daphnia magna Chronic Toxicity / OECD 211
- 4.10 Hyalella azteca Acute Toxicity
- 4.11 Freshwater Fish Acute Toxicity / OECD 203
- 4.12 Earthworm subacute Toxicity / OECD 207
- Freshwater Fish early life-stage Toxicity / OECD 210