Used to determine the presence of both water-soluble (aqueous extraction) and solvent-soluble (non-aqueous extraction) substances, physicochemical tests are used to characterize and compare polymeric materials to one another or to audit materials.
Used for implants to determine the amount of water soluble and solvent soluble substances that equal ≥90% of the total extractables, on a gravimetric basis.
Fourier transform infrared spectroscopy (FTIR) is useful for identifying, characterizing, or “fingerprinting” organic chemical structures, and illustrating the vibrational features of all sample components.
High-performance liquid chromatography (HPLC) is a form of liquid chromatography used for separating compounds in a solution.
Mass spectrometry (MS) is an analytical detection method that measures the mass-to-charge ratio (M/Z) of ionized atoms or molecules. This technique is used to separate these atoms and molecules from one another.
Gas chromatography (GC) is the separation of vaporizable chemical substances and particles by differential movement through a two-phase absorption system.
Inductively coupled plasma spectrometry (ICP) is a multi-element analysis technique that dissociates the sample into its constituent atoms or ions, exciting them to a level where they emit light of a characteristic wavelength.
Physical and Mechanical (Instron)
Tensile strength data are usually gathered on plastic formulations or molded plastic parts in order to avoid failures during the intended use of the device. Besides tensile strength, other physical data, such as elongation and Young’s modules, are also obtained from tensile tests.
Specific gravity is the ratio of the weight of a substance to the weight of an equal volume of purified water at the same temperature. It is useful in characterizing the identity, purity, and concentration of a material.
This ASTM method measure the hardness of plastic materials by using a durometer. This is an efficient test often used to check the uniformity of the fabricated material from lot to lot.
Gel-permeation chromatography (GPC), also known as gel-filtration or size-exclusion chromatography, is an analytical method used to analyze the molecular weight and molecular weight distribution in a plastic formulation to assure product uniformity.
In general, viscosity is defined as the resistance to or alteration of flow by any substance as a result of molecular cohesion. The term is most frequently applied to liquids as the resistance of a fluid to flow because of a shearing force.
Scanning electron microscopy (SEM) is a direct examination of surface topography that provides a unique understanding of a material’s characteristics, appearance of interfaces, solvent bonds, surface finish, and particle sizing below the limits of light microscopy. X-ray diffraction (XRD) is commonly used to identify solid and liquid materials and to determine their composition.
Differential scanning calorimetry (DSC) is an analytical method that independently measures the rate of heat flow to a sample against a reference standard of the same temperature. DSC measures heat capacities, phase transitions, dehydration, and decomposition reaction.