Analytical Method Development
Our team tailors analytical methods to each stage of your drug development program. Whether you’re in early-phase clinical research or commercial production, we ensure efficiency, cost-effectiveness, and compliance with quality requirements. Our services include:
HPLC Analytical Method Development and Validation
– Assay determination
– Related substances analysis
– Dissolution testing
Cleaning Validation and Verification
– Ensuring equipment cleanliness and product safety
Pharmacopoeia Testing
– Testing raw materials and finished products according to USP/NF, EP, BP, JP, and client-specific methods
Proton NMR and Carbon-13 NMR Services
– Providing detailed structural information
Clinical Trial Support
– Method development and batch release for clinical trials
Elemental Analysis
– Determining carbon, hydrogen, and nitrogen content
Liquid Chromatography-Mass Spectrometry (LC-MS) Services
– Identifying and quantifying compounds
Infrared Spectroscopy Services
Method development and batch release for clinical trials
UV Spectroscopy Services
– Analyzing UV-visible absorption spectra
Detecting solvents in drug products
– Separating and analyzing volatile compounds
Residual Solvent Analysis
– Detecting solvents in drug products
Ion-Chromatography Services
– Analyzing cations and anions
Gas Chromatography Services
– Separating and analyzing volatile compounds
Lyophilization of Small Molecules and Biologics
– Freeze-drying for stability and preservation
Method Validation
Our team develops custom validation protocols based on parameters, processes, and acceptance criteria. We ensure compliance with ICH and FDA guidelines. Once methods are validated, we provide thorough reports suitable for regulatory submission.
Why Choose BioLink Lifesciences?
Our scientists have extensive experience with diverse molecules, materials, formulations, and packaging configurations.
We adhere to ICH, GMP (Good Manufacturing Practice), and GLP (Good Laboratory Practices) standards.
Our rigorous testing ensures safe and effective pharmaceutical products.