Analytical Development

BioDuro-Sundia’s Analytical Testing team offers high quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, and CMC dossier preparation services.

Drug Substance
cGMP Compliant Method Development & Validation

• Starting materials
• Intermediates
• APIs
• Qualification of reference standards

API Characterization

• Physical properties
• Impurities identification
• Structure elucidation & confirmation
• Chemical characterization

API Testing & Release

Drug Substance specification support

Analytical support for Formulation Development

Stability Management & Testing (according to ICH/FDA/CFDA guidelines)

• Stability indicating method validation & transfer
• Preparation & Approval of stability protocol
• Sample management
• Sample testing
• Data & trend analysis & preparation
• analytical training, documentation & internal audit

Stability Conditions include 

• 20°C
• 5°C
• 25°C/60%RH
• 30°C/65%RH
• 30°C/60%RH
• 40°C/75%RH
• 50°C
• Photostability

Drug Product
Method Evaluation Development & Optimization
Method Transfer & Validation

Drug Product specification & Support

Stability Studies

• Siemens APOGEE Monitoring System
• Full generator backup
• Drug product, drug substance, placebo
• Testing Capabilities: XRPD; Dissolution; Karl Fisher

Drug Product Testing & Release

• Assay/impurities testing & method validation
• Dissolution testing and method validation
• Blend/content uniformity testing & method validation
• Cleaning verification/validation
• Protocol design
• Long term stability testing
• In-use stability testing
• Accelerated stability testing
• Forced degradation studiesTemperature cycling
• Storage conditions: 25ºC/60% RH; 30ºC/65% RH; 40ºC/75% RH; 2-8ºC; -20ºC
• Siemens APOGEE Monitoring System
• Full generator backup
• Drug product, drug substance, placebo
• Testing Capabilities: XRPD; Dissolution; Karl Fisher