Get Drug Characterization 2020-2025

Characterization testing is used to gain an understanding of the physical and chemical properties of pharmaceutical materials. During process and drug development, these properties can have an impact on the product's performance, ability to be processed, stability and appearance.

The characterization of a solid should describe the features of its composition and structure (including defects) that are significant for the reproduction of the synthesis and for the study of its properties or use.

Material characterization refers to tests that are performed to better understand the physical and chemical properties of the raw materials and the active ingredient. During the drug manufacturing process, these properties can influence product safety, performance, visibility, and stability.

Successful approval of biologics depends on robust product characterization — an analytical data package that defines the characteristics and structure of the biotherapeutic and proves the safety, efficacy, purity, quality, and strength.

The primary goal of product characterization is to ensure safety, purity, identification, and accurate potency. New biologic drugs are designed with a clear mode of action. For example, a monoclonal antibody (mAb) directed against a tumor marker would seek to kill the tumor cells.

Thin-layer chromatography (TLC), liquid chromatography (LC), gas chromatography (GC), and chromato- graphic fingerprinting are used widely to separate and quantify the chemical compounds present in dosage forms, and to subsequently differentiate falsified and substandard products from authentic products.

Characterization testing is used to gain an understanding of the physical and chemical properties of pharmaceutical materials. During process and drug development, these properties can have an impact on the product's performance, ability to be processed, stability and appearance.

Characterization of the API solid state is key to reduce possible future manufacturing or formulation issues and cut drug product development costs and time. Solubility and permeability of the solid-state dictate bioavailability and thus dosage form efficacy.