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 and animal health 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 (ERAs) under European Union Directive 200/83/EC. ERAs are required if the Predicted Environmental Concentration (PEC is >0.01 ppb in water or ≥10 ppb in soil, or if effects are suggested at lower concentrations based on related substances or biological studies. Environmental risk assessments are required for all new animal health drugs.
Physical-Chemical Properties
- Water Solubility (FDA TAD 3.01 / OECD 105)
- n-Octanol/Water Partition (FDA TAD 3.02 / OECD 107 or 117)
- Vapor Pressure (FDA TAD 3.03 / OECD 104)
- Dissociation Constant (FDA TAD 3.04 / OECD 112)
- Ultraviolet-Visible Adsorption Spectrum (FDA TAD 3.05 / OECD 101)
- Melting Temperature (FDA TAD 3.06 / OECD 102)
- Density and Relative Density (FDA TAD 3.07 / OECD 109)
Environmental Fate
- Sorption/Desorption (FDA TAD 3.08 / OECD 106)
- Hydrolysis (FDA TAD 3.09 / OECD 111)
- Photodegradation in Water (FDA TAD 3.10 / OECD Monograph 61)
- Aerobic Biodegradation in Water (FDA TAD 3.11 / OECD 301 and 302 Series)
- Aerobic Biodegradation in Soil or Sediment (FDA TAD 3.12/ OECD 307 or OECD 308)
Environmental Effects
- Algal Toxicity (FDA TAD 4.01 / OECD 201)
- Microbial Growth Inhibition / OECD 209 Activated Sludge Respiration Inhibition (FDA TAD 4.02 or OECD 209)
- Seed Germination & Root Elongation (FDA TAD 4.06 / OECD 208)
- Seedling Growth (FDA TAD 4.07 / OECD 208)
- Acute Toxicity (FDA TAD 4.08 / OECD 202)
- Chronic Toxicity (FDA TAD 4.09 / OECD 211)
- Acute Toxicity (FDA TAD 4.10)
- Fish Acute Toxicity (FDA TAD 4.11 / OECD 203)
- Earthworm Subacute Toxicity (FDA TAD 4.12 / OECD 207
- Fish Early Life-Stage Toxicity (OECD 210)
- Earthworm Reproduction Toxicity (OECD 222)
- Soil Arthropod Toxicity (ISO 11270)
- Soil Microorganisms: Nitrogen or Carbon Transformation (OECD 216 or 217)