Material Characterization Screens of Raw Materials

Material characterization screens of raw materials (active drugs, excipients, or formulated products) are used to evaluate potential raw materials to determine whether they are sufficient quality to meet the goals of the device and qualified to be released into production. STEMart provides a comprehensive set of tests for characterization screens of raw materials to help manufacturers select their suppliers and ensure the consistence of product.

Our Test Service

• For Medical Device Manufacturers
  • Cytotoxicity
  • Bioburden
  • Fourier Transfer Infrared (FTIR) Spectroscopy
  • Differential Scanning Calorimetry (DSC)
  • Particulate Matter
  • Physicochemical USP Plastics Tests
  • Residual Manufacturing Materials – Cleaning Validation
• For Pharmaceutical Manufacturers
  • Extractables and leachables (E&L) testing for pharmaceutical containers and stoppers
  • Active pharmaceutical ingredients (APIs) for potency, purity, and impurities
  • Physicochemical USP plastics tests

Usually, physical characterization covers bulk properties of API, solid-state properties of API, and intrinsic properties of API, while chemical characterization includes confirmation of the structure of API and stability analysis.

Differential Scanning Calorimetry (DSC) measures the temperature and heat flows associated with transitions in materials as a function of time and temperature in a controlled atmosphere. There are two types of DSC: power compensated DSC and heat flux DSC. For the power compensated DSC method, the temperature of the sample and reference material are always kept the same by varying the heat flow to the sample and reference during the linear temperature scanning process. For the heat flux DSC, The temperature is directly recorded during the same procedure. The change in temperature can be converted to heat flow difference together with the thermal resistance.

Fourier Transfer Infrared (FTIR) Spectroscopy is molecular spectroscopy which is used to characterize both organic and inorganic evidence. When the frequency of the infrared radiation matches the natural frequency of the bond, the sample will be bombarded with infrared radiation. The amplitude of the vibration increases and the infrared is absorbed. For pure chemicals or materials, FTIR can assist in the identification of the substance. FTIR is most often used to compare material from lot to lot, before and after a processing step to check for equivalency or to aid in the identification of particulate contamination on a product.

With extensive expertise in Material Characterization Screens of Raw Materials, STEMart can provide a full-service experience, support manufacturers to meet the regulatory goals, and minimize the compliance risks. If you have additional questions about Material Characterization Screens of Raw Materials or would like to find out more about our services, please feel free to contact us.