LABORATORY SERVICES

Our multiple, well-fitted laboratories support our drug development  program with analytics and extensive quality control programs to meet or exceed FDA compliance standards. From pre-formulation to commercialization, our laboratories support every aspect of your project.

Analytical Method Development

Assessment for Small and Macromolecules

Stability-Indicating Assays

Chromatography by HPLC

Robustness

Gas Chromatography

UV-VIS

Refractive Index

IR Spectroscopy

Wet Chemistry

Extractables and Leachables

Dissolution Studies

Solution Stability

Filter/Flush Evaluation

Method Precision (intermediate and reproducibility)

Limit of Detection

Limit of Quantitation

Linearity and Range

Specificity, Including Forced Degradation Analysis

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