Impurity testing

Impurity testing
LAB Service Request

Provides an extensive set of assessments for impurity qualification, covering genotoxicity and systemic toxicology studies. Additionally, offers in-silico screenings based on QSAR for ANDA and other submissions.

Analytical Testing
Essential components of regulatory filings alongside the development of methods, characterization, and analysis of dosage formulations for test materials.
  • Packaging Testing- Agrochemicals
  • Soils Characterization, Residue, Environmental Fate and Metabolism Studies
  • Test item Characterization
  • Physico-Chemical Properties and Five Batch Analysis
  • Method development and validation
  • Dose Formulation analysis (Stability, Homogeneity and nominal concentration)
Genotoxicity
Incorporate both in vitro and in vivo investigations to identify potential carcinogenic or mutagenic agents capable of inducing genetic changes in somatic or germ cells. Additionally, assess the potential for DNA damage that could impact chromosomal structure or disrupt the mitotic apparatus, leading to variations in chromosome number.
  • Extended One Generation Reproductive Toxicity Study (EOGRTS) In Rat (OECD 443)
  • Teratogenicity/Embryo-Fetal Developmental Toxicity Study in Rabbit- Segment 2 (ICH S5 R3)
  • Fertility and Early Embryonic Development Study in Rat and Mice -Segment 1 (ICH S5 R3)
  • Prenatal Developmental Toxicity Study in Rat and Rabbits (OECD 414)
  • Combined Repeated Dose Toxicity Study with the Reproduction and Developmental Toxicity Screening Test in Rat (OECD 422)
  • Reproduction and Developmental Toxicity Screening Test in Rat (OECD 421)
  • Juvenile (Neonatal) Toxicity Study in Rat and Mice
  • Male Fertility Study in Rat
  • Pre & Postnatal Developmental Toxicity Study in Rat and Mice -Segment 3 (ICH S5 R3)
Repeated Dose Toxicity (Subacute, Subchronic and Chronic)
Incorporate routine assessments for Subacute, Subchronic, and Chronic Toxicity Testing, including comprehensive determination of clinical pathology.
  • Method development and validation
  • Dose Formulation analysis (Stability, Homogeneity and nominal concentration)
ACF GHS Report