Analytical Services
How do I ensure the performance of my drug product?
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Accelerate your product analysis
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
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
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
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
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
Analytical services