Analytical Services

We pride ourselves on providing the best analytical support, delivering candidate screening, drug product analysis and phase-appropriate method development and validation as part of our programs. 

We have extensive experience testing of drug products at all stages, 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

We work with you to understand your analytical objectives and ensure that appropriate methodologies are available at all stages, with support and capabilities for:

• 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/II drug products
• Finalization of analytical methods to support your Phase III, registration, and commercial drug products 

Quotient Sciences' stability storage and testing service satisfies ICH guidelines for the stability assessment of your drug product. 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