Analytical
Our analytical chemists have extensive experiences in supporting both drug discovery and development.We have comprehensive analytical instruments.We provide services ranging from various single sample tests; Structure Elucidation and Solid-State Characterization, method development and validation for pre-clinical and clinical studies, as well as stability storage and testingunder ICH guidelines.Our laboratory meets the GLP requirements.

Examples of our instrumentation and equipments Dissolution (App. I, II) HPLC, LC/MS GC, GC/HS FTIR, NMR UV-Vis/Fluorescence pKa titrator TGA, DSC ICP/OES KF

Methods Development and Validation
Analytical methods can be developed and validated per ICH or other guidelines for drug substance and drug product release testing and stability testing.

Develops analytical methods for the following applications Stability Indicating Potency, Impurities Dissolution Moisture Metals Residual solvents DMF updates Others as requested Typical characteristics to validate Method precision (intermediate and reproducibility) Limit of detection (LOD) Limit of quantitation (LOQ) Accuracy and recovery Linearity and range Specificity, including forced degradation analysis Robustness Solution stability

Structure Elucidation and Solid-State Characterization
Includes isolation, purification and structural elucidation of impurities, metabolites and degradants utilizing analytical techniques such as NMR and MassSpec.  In addition, we offer solid-state characterization services to determine crystallinity, polymorph and particle size distribution.

Structural Elucidation NMR FTIR MS and MS/MS Elemental Analysis (CHN/SO) High Resolution LC/MS

Solid-State Characterization

• DSC/TGA
• XRPD
• Particle size distribution

Stability Storage and Testing
Our stability operations have extensive storage capacity for common ICH conditions.All of our chambers are continuously monitored through and are on full generator back-up. Core testing and analysis expertise covers: R&D preliminary studies, drug product, comparator studies and additional capabilities for photostability studies.

Stability Testing

• API
• Drug product
• R&D preliminary stability (protocol development, testing and evaluations)
• Setting of specifications