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ASTM D5227-21, the Standard Test Method for Measurement of Hexane Extractable Content of Polyolefins, provides a crucial gravimetric procedure for determining low molecular weight soluble materials in polyolefin resins. Applicable to polyethylene (LDPE, HDPE, LLDPE), polypropylene (PP), ethylene-propylene copolymers, and ethylene-vinyl acetate (EVA) copolymers, this method is essential for ensuring compliance with regulatory limits on extractables, particularly those outlined by the FDA in 21 CFR 177.1520.
This test method is a direct modification of the FDA procedure, specifically designed to simplify the workflow. While the traditional FDA method requires the complex and time-consuming evaporation of the extraction solvent, D5227 presumes that the weight loss of the extracted film is equal to the extractable content (Section 4.2). This allows laboratories to quantify the extract directly via a simple gravimetric loss-on-extraction measurement, applicable to resins containing greater than 0.20% extractables (Section 5.1). There is currently no known ISO equivalent to this standard (Note 1).
The extraction procedure is tightly controlled to ensure reproducibility and accuracy. In accordance with Section 4.1, film samples are extracted using hexane as the solvent at a precisely controlled temperature of 49.5 ± 0.5°C for a duration of 2 hours. After the extraction cycle is complete, the film samples are carefully dried and re-weighed to determine the mass of low molecular weight material lost to the solvent.
| 🟦 Parameter | 📐 Specification | 🎯 Reference |
|---|---|---|
| Extraction Solvent | Hexane | Section 4.1 |
| Extraction Temperature | 49.5 ± 0.5 °C | Section 4.1 |
| Extraction Duration | 2 hours | Section 4.1 |
| Measurement Method | Gravimetric (Film Weight Loss) | Section 1.1, 4.2 |
| Detection Threshold | > 0.20% Extractables | Section 5.1 |
The standard leverages terminology from associated ASTM standards such as D883 (Plastics), D1600 (Abbreviated Terms), and E131 (Molecular Spectroscopy). The primary materials covered under this test method are summarized below. The standard also specifically references Practice E691 for conducting interlaboratory studies to determine the precision of the test method.
| 📏 Material | 🎯 Abbreviation | ⚡ Typical Application |
|---|---|---|
| Low-Density Polyethylene | LDPE | Highly branched resin for flexible films. |
| High-Density Polyethylene | HDPE | Linear resin for rigid containers and pipes. |
| Linear Low-Density Polyethylene | LLDPE | Short-chain branched resin for stretch films. |
| Polypropylene | PP | Versatile thermoplastic for packaging and textiles. |
| Ethylene-Vinyl Acetate | EVA | Flexible copolymer used in specialty films. |
ASTM D5227-21 presumes the weight loss of the extracted film is equal to the mass of extractables (Section 4.2). This fundamental shift eliminates the complex and time-consuming solvent evaporation process used in the FDA method (21 CFR 177.1520), making the test much faster while maintaining accuracy for polyolefins.
The method specifies an extraction with hexane for exactly 2 hours at a controlled temperature of 49.5 ± 0.5°C.
According to Section 1.1, this test method is applicable to polyethylene, polypropylene, ethylene-propylene copolymers, and ethylene-vinyl acetate (EVA) copolymers.
No. Note 1 of the standard explicitly states that there is no known ISO equivalent to ASTM D5227-21.