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USP Physicochemical Test

USP Physicochemical Test

The USP Physicochemical test series 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.

Testing is necessary in order to comply with USP General Chapter 32 and National Formulary 27, 2009 regulations. The procedure is described in the USP General Chapter 661 Nelson Laboratories offers extensive experience testing different types of plastics.

Applicable Standards

  • USP 661

Test Options

Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test Request Quote
PCT101 USP Physicochemical, Plastics: Complete Add
PCT105 USP Physicochemical, Plastics: Complete w/o Residue on Ignition Add
PCT110 USP Physicochemical, Plastics: Buffering Capacity only Add
PCT115 USP Physicochemical, Plastics: Non-volatile Residue only Add
PCT120 USP Physicochemical, Plastics: Heavy Metals (Method I) only Add
PCT125 USP Physicochemical, Plastics: Residue on Ignition w/ Non-volatile Residue Add
PCT210 USP Physicochemical, Elastomeric Materials: Aqueous samples Add
PCT220 USP Physicochemical, Elastomeric Materials: Drug Product samples Add
PCT230 USP Physicochemical, Elastomeric Materials: Alcohol samples Add
PCT300 Chemical tests on extracts, ISO 8536-4 Annex B tests Add
PCT301 USP Physicochemical Tests: Polypropylene/Polyethylene Complete w/o ROI Add
PCT305 USP Physicochemical Tests: Polypropylene/Polyethylene Complete with ROI Add
PCT101 - USP Physicochemical, Plastics: Complete
PCT105 - USP Physicochemical, Plastics: Complete w/o Residue on Ignition
PCT110 - USP Physicochemical, Plastics: Buffering Capacity only
PCT115 - USP Physicochemical, Plastics: Non-volatile Residue only
PCT120 - USP Physicochemical, Plastics: Heavy Metals (Method I) only
PCT125 - USP Physicochemical, Plastics: Residue on Ignition w/ Non-volatile Residue
PCT210 - USP Physicochemical, Elastomeric Materials: Aqueous samples
PCT220 - USP Physicochemical, Elastomeric Materials: Drug Product samples
PCT230 - USP Physicochemical, Elastomeric Materials: Alcohol samples
PCT300 - Chemical tests on extracts, ISO 8536-4 Annex B tests
PCT301 - USP Physicochemical Tests: Polypropylene/Polyethylene Complete w/o ROI
PCT305 - USP Physicochemical Tests: Polypropylene/Polyethylene Complete with ROI

Sample Specifications

PCT101: 20 grams, 300 cm2 (if >0.5 mm thickness) or 600 cm2 (<0.5 mm thickness)
PCT105: 20 grams, 300 cm2 (if >0.5 mm thickness) or 600 cm2 (<0.5 mm thickness)

Study Outline

USP Physicochemical testing may consist of four analyses: buffering capacity, nonvolatile residue (NVR), residue on ignition (ROI) or heavy metals.

Sample Extraction
The sample is extracted in the required extraction media at 70 ± 2°C (water and alcohol) or 50 ± 2°C (hexanes) for 24 ± 2 hours. Other extraction times and temperatures may be used if requested, but the USP General Chapter 661 limits may not be applicable.

For polyethylene or polypropylene samples, the recommended tests are heavy metals (water extraction only) and NVR (water, alcohol and hexanes extractions). The buffering capacity test (water extraction only) is also recommended when the samples may be in contact with oral liquids.

For general plastics, all four analyses are recommended using a water extraction. The ROI test is not required when the nonvolatile residue does not exceed 5 mg.

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

Nonvolatile residue (NVR): This test quantifies any substances in the extract which do not volatilize at or above a temperature of 105°C.

Residue on ignition (ROI): This test quantifies any substances from the nonvolatile residue test which do not volatilize at or above 600°C in the presence of sulfuric acid. An NVR test must be performed prior to an ROI test.

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

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