Raw material characterization

Physicochemical test, elastomerics materials (alcohol) USP 381

This series of tests is designed to aid in characterizing both the physical and chemical properties of elastomeric materials.  The isopropyl alcohol (IPA) extraction procedure is described in the USP <381> and may consist of two analyses:

• Turbidity
• Total Extractables

Physicochemical test, elastomeric materials (drug product) USP 381

This series of tests is designed to aid in characterizing both the physical and chemical properties of elastomeric materials.  The drug product vehicle (DPV) extraction procedure is described in the USP <381> and may consist of four analyses:

• Turbidity
• Heavy Metals
• pH Change
• Total Extractables

Physicochemical test, elastomeric materials (aqueous) USP 381

This series of tests is designed to aid in characterizing both the physical and chemical properties of elastomeric materials.  The aqueous extraction procedure is described in the USP <381> and may consist of five analyses:

• Turbidity
• Reducing Agents
• Heavy Metals
• pH Change
• Total Extractables

USP Physicochemical tests, plastics USP 661

This series of tests is designed to aid in characterizing both the physical and chemical properties of plastics or polymers.  This method is intended for homogeneous plastic samples, though it may be applied to other sample types if requested.  The procedure is described in the USP <661> and may consist of four analyses:

• Buffering capacity
• Nonvolatile residue (NVR)
• Residue on ignition (ROI)
• Heavy metals

USP <661> also discusses thermal analysis and multiple internal reflectance testing of polymers, specifically polyethylene and polypropylene.  Refer to DSC and FTIR.

Infrared analysis (FTIR) ISO 10993-12, ISO 10993-18

This test allows for obtaining absorption spectra on samples and analyzing against selected libraries.  We can provide a historical analysis by selecting libraries of previously tested samples to compare with new samples.  This can be done for different lots to determine equivalency.

An infrared spectrum is characteristic of a particular compound providing information about its functional groups, molecular geometry and inter-/intra-molecular interactions.  The infrared spectrometer provides a record of the infrared absorbency or transmittance of a sample as a function of wave number. The frequencies at which absorption occurs may indicate the type of functional groups present in the substance.  The absence of an absorption band may indicate the absence of a functional group.  Mathematical analysis of the raw data applies a Fourier Transform (FT) and results in a visual spectrum showing characteristic frequencies in the infrared range between 4000cm^-1 and 200 cm^-1.

Differential scanning calorimetry (DSC) ISO 10993-12, ISO 10993-18

DSC is a technique which profiles calorie loss or gain from a substance heated at a constant rate. DSC is a method that allows for the determination of the thermal properties of materials. These are properties such as melting points, glass transition temperatures, and other phase changes.