Endotoxin Testing of Copolyester Pellets

Example 11

Polymer pellets of succinic acid-1,4-butanediol-malic acid copolyester were tested for endotoxin content using the Bacterial Endotoxin Test (BET) Gel Clot method per USP<85>. Before testing, the pellets were sterilized by exposure to ethylene oxide gas. The extraction was performed at a ratio of 1 gram of polymer in 10 mL of endotoxin-free water; then, a 1:8 dilution of the sample extract was prepared and tested by the gel clot method. The results yielded<2.5 EU/g of polymer.

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US11878087B2. Oriented implants containing poly(butylene succinate) and copolymer, and methods of use thereof (2024-01-23). Tepha, Inc. [US]. Inventors: Simon F. Williams [US], Said Rizk [US], David P. Martin [US].

Patent 2024

Butanediol Clot Dilution Endotoxin Ethylene oxide Malic acid Pellets Polymer Succinic acid

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Variable analysis

independent variables

Sterilization of polymer pellets by exposure to ethylene oxide gas

dependent variables

Endotoxin content of polymer pellets

control variables

Extraction ratio of 1 gram of polymer in 10 mL of endotoxin-free water
1:8 dilution of the sample extract

controls

Positive control: Not mentioned
Negative control: Not mentioned

Annotations

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