Propylene polymers are long-chain polymers synthesized from propylene or propylene and other olefins under controlled conditions of heat and pressure, with the aid of catalysts. The suitability of a specific polypropylene must be established by appropriate testing. Polypropylene has a distinctive IR spectrum and possesses characteristic thermal properties. It has a density between 0.880 and 0.913 g per cm3. The permeation properties of molded polypropylene containers may be altered when reground polymer is incorporated, depending on the proportion of reground material in the final product. Other properties that may affect the suitability of polypropylene used in containers for packaging drugs are the following: oxygen and moisture permeability, modulus of elasticity, melt flow index, environmental stress crack resistance, and degree of crystallinity after molding.
The requirements in this section are to be met when dry solid and liquid oral dosage forms are to be packaged in a container defined by this section.
Infrared Spectroscopy—Proceed as directed for Test Methods, Multiple Internal Reflectance. The corrected spectrum of the specimen exhibits major absorption bands only at the same wavelengths as the spectrum of the respective USP Homopolymer Polypropylene RS or copolymer polypropylene standard, similarly determined. Differential Scanning Calorimetry—Proceed as directed for Test Methods, Thermal Analysis. The temperature of the endotherm (melt) in the thermogram does not differ from that of the USP Reference Standard for homopolymers by more than 6.0°. The temperature of the endotherm obtained from the thermogram of the copolymer polypropylene specimen does not differ from that of the copolymer polypropylene standard by more than 12.0°.
Heavy Metals and Nonvolatile Residue—Prepare extracts of specimens for these tests as directed for Test Methods, Physicochemical Tests, Sample Preparation, except that for each 20 mL of Extracting Medium the portion shall be 60 cm2, regardless of thickness.
HEAVY METALS—Containers meet the requirements for Test Methods, Physicochemical Tests, Heavy Metals.
NONVOLATILE RESIDUE—Proceed as directed for Test Methods, Physicochemical Tests, Nonvolatile Residue, except that the Blank shall be the same solvent used in each of the following test conditions: the difference between the amounts obtained from the Sample Preparation and the Blank does not exceed 10.0 mg when water maintained at a temperature of 70° is used as the Extracting Medium; does not exceed 60.0 mg when alcohol maintained at a temperature of 70° is used as the Extracting Medium; and does not exceed 225.0 mg when hexanes maintained at a temperature of 50° is used as the Extracting Medium. Containers meet these requirements for Nonvolatile Residue for all of the above extracting media. [NOTE—Hexanes and alcohol are flammable. When evaporating these solvents, use a current of air with the water bath; when drying the residue, use an explosion-proof oven.]
Components Used in Contact with Oral Liquids—Proceed as directed for Test Methods, Physicochemical Tests, Buffering Capacity.
SOURCE FROM USP
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