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Pharmacopoeia UE/USP

Plastic materials that come in contact with drugs must meet a number of pharmacopoeia requirements.

The main reference documents accepted worldwide based on the region of application are the European Pharmacopoeia (EP) and the US Pharmacopoeia (USP).

Each is a compendium of official monographs that provide a scientific basis for quality control during a product’s entire life cycle. These pharmacopoeias also include protocols to be followed to ensure the quality of drugs, excipients and drug packaging.

Testing in accordance with European and US pharmacopoeia requirements

European Pharmacopoeia

Analysis of the polymers described in subsection 3.1 Materials used in the Manufacture of Pharmaceutical Containers, such as polyolefins, polyethylene (PE) with and without additives, polypropylene (PP), ethylene vinyl acetate (EVA), silicone and polyvinyl chloride (PVC).

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United States Pharmacopoeia

Analysis of the polymers described in subsection 661 Plastic Packaging Systems and Their Materials of Construction, such as high-density polyethylene (HDPE), low-density polyethylene (LDPE), PP, polyethylene terephthalate glycol (PETG) and PVC, and subsection 671 Containers – Performance Testing.

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Tests performed at AIMPLAS

After providing assistance to select the applicable standard, AIMPLAS performs a number of common tests to characterize these materials, including the following:

  • Differential scanning calorimetry (DSC)
  • Fourier-transform infrared (FTIR) spectroscopy and infrared (IR) spectroscopy
  • Absorbance
  • Appearance
  • Acidity / alkalinity
  • Reducing agents
  • Sulphated ash
  • Total organic carbon (TOC)
  • Heavy metals (compared with a reference substance)
  • Non-volatile residue
  • Extractable metals
  • Substances soluble in hexane
  • Residue on ignition
  • Buffering capacity
  • Transmittance
  • Moisture permeability
  • Viscosity
  • Relative density
  • Mineral oils (compared with a reference substance)
  • Materials stabilized with and without tin (compared with a reference substance)
  • Identification of permitted additives
  • Identification of residual solvents
  • Identification of monomers (e.g. terephthaloyl, ethylene glycol and vinyl chloride units) and degradation products such as acetaldehyde