USP POLYETHYLENE CONTAINERS Scope and Background

POLYETHYLENE CONTAINERS Scope and Background

Scope

The standards and tests provided in this section characterize containers and components produced from either low-density polyethylene or high-density polyethylene of either homopolymer or copolymer resin. All polyethylene components are subject to testing by IR spectroscopy and differential scanning calorimetry. Where stability studies have been performed to establish the expiration date of a particular dosage form in the appropriate polyethylene container, then any other polyethylene container meeting these requirements may be similarly used to package such a dosage form, provided that the appropriate stability programs are expanded to include the alternative container, in order to ensure that the identity, strength, quality, and purity of the dosage form are maintained throughout the expiration period.

Background

High-density and low-density polyethylene are long-chain polymers synthesized under controlled conditions of heat and pressure, with the aid of catalysts from not less than 85.0% ethylene and not less than 95.0% total olefins. Other olefin ingredients that are most frequently used are butene, hexene, and propylene. High-density polyethylene and low-density polyethylene both have an IR absorption spectrum that is distinctive for polyethylene, and each possesses characteristic thermal properties. High-density polyethylene has a density between 0.941 and 0.965 g per cm3. Low-density polyethylene has a density between 0.850 and 0.940 g per cm3. Other properties that may affect the suitability of polyethylene include modulus of elasticity, melt index, environmental stress crack resistance, and degree of crystallinity after molding.

HDPE pill container

Source from USP