Pharma and Chem

Pharmaceutical & Chemical Analysis Services

Analytical method development for raw materials, drug substances and drug products. Separation optimization for impurity and degradation products. Accelerated stability testing and excipient compatibility studies.

Key Benefits

  • Strong method development expertise
  • Small molecule and protein therapeutics
  • Excel in separation technology
  • Focusing on method robustness and ruggedness
  • Guaranteed method transferability
  • Dedication to customer service

Capabilities

  • Stability-indicating analytical method development
  • Accelerated excipient compatibility screening
  • Accelerated stress studies
  • Degradation product and pathway identification
  • Drug substance and product assay
  • Impurity and degradation product assay
  • Method validation and transfer
  • Chiral separation
  • Ion-pairing chromatography
  • Compendial methods
  • LC/MS/MS methods for pharmaceutical products

Pharmacokinetics LC/MS/MS

Bioanalytical method development and GLP sample testing for pharmacokinetic/toxicokinetic studies.

Key Benefits

  • Strong commitment to GLP compliance
  • Fast turn-around time
  • Exceptional technical excellence
  • Automated laboratory sample and data management system
  • API-4000 LC-MS/MS
  • Dedication to customer service
  • Capabilities
  • Bioanalytical method development
  • Bioanalytical method validation
  • GLP bioanalytical sample analysis
  • Research sample analysis
  • Protein binding
  • PK data analysis and report
  • PK/PD modeling

Drug Metabolism Metabolite Synthesis

Drug metabolism is an important area for understanding the dispositional fate of drug candidates. Phase I and II metabolism result in chemical modification and conjugation of parent compound. Typically more water soluble metabolites are formed which facilitates the excretion of the drug through renal or biliary excretion routes.
To speed up the drug development process, drug metabolism studies are typically conducted at discovery lead screening stage and more detailed characterization follows when the drug enters clinical trials.

  • In vitro drug metabolism studies
  • Metabolic pathway identification
  • Metabolic synthesis of major drug metabolites (mg to g scale)

 

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