Analytical Services

How do I ensure the performance of my drug product?

Access to experienced analytical scientists and state-of-the-art equipment is critical to the success of your drug development program. At Quotient Sciences, we pride ourselves on providing the best analytical support, delivering candidate screening, drug product analysis and phase-appropriate method development and validation.

Candidate screening

Candidate screening

Our material science experts have a proven track record in rapidly characterizing API properties in order to support the selection of lead drug product formats for pre-clinical and clinical evaluation:

  • Physicochemical properties
  • Solid form definition and analysis
  • Excipient compatibility testing
  • Amorphous vs. crystalline solid state testing
  • Aqueous and solvent solubility
  • Solid state stability
Two scientists in the lab troubleshooting an HPLC machine.

Analytical development

We understand your analytical objectives throughout the drug development process and work with you to ensure that appropriate methodologies are available at all stages. We offer support and trouble-shooting capabilities including:

  • Rapid development of analytical methods to support your early formulation prototype characterization including assay, purity and dissolution
  • Development of phase-appropriate methods to support batch release and stability testing of your Phase I and Phase II drug product manufacturing
  • Finalization of analytical methods to support your Phase III, registration and commercial drug product manufacturing
A scientist filling vials using the vial machine in the Quotient Sciences Laboratory.

Analytical testing

We have extensive experience in the testing of drug products from preclinical development through to commercial drug products including:

  • Preclinical prototype evaluation including biorelevant characterization of your solid oral dosage forms
  • Excipient compatibility to support your prototype selection
  • Finished product testing including purity, dissolution and physical characterization
  • ICH stability testing of your early and late stage drug products
  • Specialists at the microbial analysis of radiolabelled compounds, cytotoxic & high potency compounds and controlled substances. Click here for more information on our microbiology capabilities.

Quotient Sciences’ formulation teams have vast experience across an array of drug product formats for administration via oral, inhaled, topical, rectal and parenteral routes.

ICH stability

We offer a full stability storage and testing service that satisfies ICH guidelines for the stability assessment of your drug products. Our fully validated, controlled and monitored stability storage includes:

  • 2–8°C
  • 25°C/60%RH
  • 30°C/65%RH
  • 30°C/75%RH
  • 40°C/75%RH
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