Our Analytical Chemistry Services provide full analytical support for research, development and commercial production of active pharmaceutical ingredients (APIs).

The dedicated team of 50 experienced analytical chemists offers broad expertise in drug development support and registration. The team works according to cGMP and GLP regulations within a state-of-the-art infrastructure.

Services

Throughout the drug development process, we provide all analytical services necessary to support the CMC (Chemistry, Manufacturing and Controls) drug substances. These services include characterization, control, reference standards and stability.

Characterization

• Structure elucidation
• Absolute configuration
• Polymorphism
• Impurity profiling
• Particle sizing
• Solubility profile
• LogP
• Salt screening
• Compatibility

Control

• Method development
• Impurity tracking
• Method verification
• Specification development
• Specification justification
• Method validation: raw material, IPC, API
• Release Analytics
• Method Transfer

Reference Standards

• Definition of primary and secondary reference standards for: APIs, Intermediates, Impurities, Raw Materials
• Preparation by synthesis or preparative isolation
• Purification by crystallization or chromatography
• Characterization according to cGMP and GLP guidelines
• Standard testing plans covering purity to absolute configuration
• Certification with assay & re-test date
• Standard management, in-house storage and distribution, periodic re-testing, re-synthesis

Stability

• Stress stability
• Drug substance ICH stability
• Drug product ICH stability
• Degradation profiling

With the latest state-of-the-art equipment and technical environment, our analytical services offer the breadth and depth to service analytical projects with great time and cost efficiency.

We are among the first companies that have implemented a Laboratory Information Management System integrating all analytical tools and methods. This "paper free" system allows efficient data capture, processing and secure data storage, which is critical to meet the requirements of the FDA with respect to 21 CFR Part 11. The system allows our customers to directly access through the Internet the analytical data generated by CarboGen on their behalf.

• Bar-coding of samples and documents
• Automatic result transfer from instruments (Interfaces to CDS, NMR, etc.)
• Automatic checks against specifications and measure limits
• Analytical documentation in electronic form
• Validated system (IQ/OQ/PQ)
• 21 CFR Part 11 Compliance (e-records, e-signatures, audit trail)