Analytical Chemistry

Analytical chemistry plays a critical role in identifying, quantifying and determining compounds used in medical devices, pharmaceuticals and biotechnology. Our experienced chemists take a scientific approach in obtaining, processing and communicating information about the structure and composition of your matter.

Understanding Analytical Chemistry

Assessing the properties of a product, whether it is an unknown material or raw materials, is crucial when it comes to developing or quality- auditing a product. To help ensure product quality, consistency and safety, we offer a comprehensive range of analytical chemistry testing services.

Analytical Chemistry Services

  • Method development and validation for biological samples and preclinical dose formulations
  • Analysis of biological samples from pharmacokinetic, toxicokinetic, ADME studies and human clinical trials
  • Characterization of test articles consisting of purity determinations, identity confirmation, and the identification and quantification of impurities and metabolites
  • Stability determination of test articles and preclinical dose formulations
  • Routine analysis of preclinical dose formulations for homogeneity and concentration
  • Organic analysis by GC, GC/MS, HPLC, LC/MS, HRAM LC/MS, LC/MS/MS
  • Elemental analysis by AA, ICP-OES, and ICP-MS
  • Characterization of polymers and impurities
  • Degradate quantitation
  • ETO Residue analysis (EO, EC, EG) – ISO 10993-7
  • Manufacturing and cleaning residue analysis

ICH Stability Testing Capabilities

  •  Long term
  • Accelerated aging
  • Forced degradation
  • Photostability

Analytical Chemistry Testing Capabilities

  • Medical Devices
  • Pharmaceutical and Biotechnology
  • Method Development and Validation
  • ICH Stability Studies
  • Extractables and Leachables
  • Bioanalytical Services
  • Water Testing

Analytical Techniques

  • GC, GC/MS
  • LC/MS
  • HRAM LC/MS
  • HPLC
  • LC / ELSD
  • Spectroscopy
  • Method Development /Transfer / Validation

Standards

  • ICH
  • OECD
  • ISO 17025

Toxikon’s Expertise in Analytical Chemistry Services

Toxikon provides comprehensive analytical services for all stages of product development. With decades of experience, our team will collaborate with you as an extension of your firm to facilitate drug and device development, achieve product safety and regulatory compliance, and maintain the highest levels of laboratory quality control. Toxikon can offer you services that will facilitate product development by reducing the potential for product and process failure.