Physicochemical USP Plastic Tests

The USP Physicochemical series of tests are designed to help characterize both the physical and chemical properties of plastics or polymers. This method is designed for homogeneous plastic samples, but can be applied to other sample types if desired.

Testing is required to comply with USP General Part 32 and National Formulary 27, 2009 regulations. The procedure is described in USP General Part 661. EUROLABoffers comprehensive experience in testing different types of plastic.

Applicable Standards

• USP 661

Sample Features

• PCT101: 20 grams, 300 cm2 (if> 0,5 mm thick) or 600 cm2 (<0,5 mm thick)
• PCT105: 20 grams, 300 cm2 (if> 0,5 mm thick) or 600 cm2 (<0,5 mm thickness)

Working Draft

USP Physicochemical tests can consist of four analyzes: buffering capacity, non-volatile residue (NVR), ignition residue (ROI), or heavy metals.

Sample Extraction

The sample is extracted for 70 ± 2 hours at 50 ± 2 ° C (water and alcohol) or 24 ± 2 ° C (hexanes) in the required extraction medium. Other removal times and temperatures may be used if desired, although USP General Section 661 limits may not apply.

Recommended tests for polyethylene or polypropylene samples are heavy metals (water extraction only) and NVR (water, alcohol and hexanes extractions). The buffering capacity test (water extraction only) is also recommended when samples come into contact with oral fluids.

For general plastics, all four analyzes are recommended using water extraction. ROI testing is not required when non-volatile sediment does not exceed 5 mg.

Buffering capacity: This test measures the amount of acid or base added to the extract that causes a significant change in ionic activity (pH).

Non-volatile residue (NVR): This test quantifies any non-volatile substances in the extract at a temperature of 105°C or higher.

Residue on Ignition (ROI): This test measures any non-volatile substances at 600°C or above in the presence of sulfuric acid, a departure from the non-volatile residue test. An NVR test should be performed before an ROI test.

Heavy metals: This test detects metallic impurities in the extract that are colored by sulfide ions. Metals that typically respond to this test include lead, mercury, bismuth, arsenic, antimony, tin, cadmium, silver, copper, and molybdenum. The total amount of heavy metals cannot exceed 1 part per million (ppm).

EUROLAB, with its highly expert team and internationally accredited laboratories, Physicochemical USP Plastic Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.