The Health Sciences Division of Exova provides a broad spectrum of standard and customized analyses to meet the requirements of the pharmaceutical industry.

Exova’s Quality Testing Services laboratories were established in response to industry needs for high quality testing and prompt service to meet the demands of production schedules. Our group of dedicated scientists and technologists provide routine analytical testing services that include raw materials and API characterization, product release testing, packaging suitability, bottle testing, full monograph testing and stability programs.

 

Raw Materials Analyses

Our capabilities include testing of active pharmaceutical ingredients and excipients to the following specifications:

• USP/NF
• EP
• BP
• JP
• FCC
• ACS
• DAC

 

Stability Storage & Testing

Our staff has years of experience in performing stability testing for many types of commercial and pre-market drug products. Our walk-in stability chambers are fully validated and continuously monitored with emergency power backup as well as emergency maintenance and troubleshooting support. Specialized storage conditions are also available.

Storage Conditions include:

• 25°C/60%RH
• 30°C/60%RH
• 30°C/65%RH
• 40°C/75%RH
• Photostability
• Freezers (-18°C to -80°C)
• Refrigerator (5°C)
• Flexible condition reach-in chambers

 

Services

• Routine chemical testing of APIs and excipients as per USP, EP, BP, JP
• Validation of compendial tests not commonly performed using specialized equipment and glassware
• Validation of compendial and non-compendial methods for APIs and excipients

 

Resources

• FT-IR
• HPLC with UV, RI, PDA, ELS and fluorescence detectors
• IC with Conductivity, Amperometric Detectors
• GC with FID, TCD, ECD and MS Detectors
• Automatic Titrators
• Rotational Viscometers
• Polarimeter
• UV-VIS Spectrophotometer
• Volumetric and Coulometric Moisture Analyzers
• Melting Point Apparatus
• ICP (MS and OES)
• Atomic Absorption Spectrophotometer with Graphite Furnace
• Particle Size Analyzer
• Dissolution Apparatus
• Disintegration Tester
• Friability Tester