Understanding Extractables and Leachables in Pharmaceutical Packaging

by Application of Green Reagents in Pharmaceutical Synthesis on Jun 19th, 2025 08:47 AM

[color=#000000][size=2][font=Helvetica Neue, Helvetica, PingFang SC, Hiragino Sans GB, Microsoft YaHei, Arial, sans-serif]A pharmaceutical packaging system is the sum of the packaging components that come into direct contact with the drug and the outer packaging components that work together to contain and protect the active ingredient and dosage form of the drug.[/font][/size][/color]

[color=#000000][size=2][font=Helvetica Neue, Helvetica, PingFang SC, Hiragino Sans GB, Microsoft YaHei, Arial, sans-serif]Extractables are compounds that can be extracted from packaging material under controlled experimental conditions. Leachables are a class of extractables that are compounds that actually migrate into the final product during the expected lifetime or exposure time of the final product.[/font][/size][/color]
[color=#000000][size=2][font=Helvetica Neue, Helvetica, PingFang SC, Hiragino Sans GB, Microsoft YaHei, Arial, sans-serif]A pharmaceutical packaging system is the sum of the packaging components that come into direct contact with the drug and the outer packaging components that work together to contain and protect the active ingredient and dosage form of the drug.[/font][/size][/color]

[color=#000000][size=2][font=Helvetica Neue, Helvetica, PingFang SC, Hiragino Sans GB, Microsoft YaHei, Arial, sans-serif]Extractables are compounds that can be extracted from packaging material under controlled experimental conditions. Leachables are a class of extractables that are compounds that actually migrate into the final product during the expected lifetime or exposure time of the final product.[/font][/size][/color]
[color=#000000][size=2][font=Helvetica Neue, Helvetica, PingFang SC, Hiragino Sans GB, Microsoft YaHei, Arial, sans-serif]Pharmaceutical packaging may include plastic, polymer, rubber and glass material components as well as printed surfaces and coatings. Extractables and leachables are chemical substances that may be released from a product or material that enters or comes into contact with the human body. Alfa Chemistry provides efficient extractables and leachables testing services to ensure that pharmaceutical products do not produce substances that may be hazardous to human health during production, storage and use.[/font][/size][/color]