Analytical Method Development Services for Accurate Results

Analytical method development is the process of creating and validating the testing procedures used to measure a drug substance or drug product. It establishes how identity, purity, potency, impurity levels, and physical properties are determined, and it produces the data needed for formulation work, stability assessment, and regulatory submissions.

ICH stability studies rely on stability-indicating methods that can detect and quantify degradation over time. These typically include HPLC and UPLC assay and related-substances methods, stress degradation studies, and supporting solid-state techniques such as XRPD and thermal characterization to track physical changes across the shelf life of a drug product.

Large and complex molecules require methods suited to their size and structure. Size exclusion chromatography measures molecular weight, polydispersity, and aggregation, LC/MS/MS supports bioanalytical assays, and ELISA provides protein quantitation. Impurity mapping is carried out separately for small molecules, proteins, peptides, and nucleic acids.

CMC analytical testing refers to the chemistry, manufacturing, and controls data that supports a drug product through development and regulatory review. It covers method development and transfer, release and stability testing, characterization, and the physicochemical measurements that confirm a product is consistent, stable, and well understood.

Ophthalmic products often need specialized characterization beyond standard release testing. Ex-vivo corneal permeability studies, including Franz cell diffusion, drug content in cornea, and permeation kinetics, assess how a drug crosses ocular tissue, while particle size analysis, rheology, osmometry, and pH measurement confirm the product is suitable for the ocular surface.