Testing of Bacterial Endotoxin in Radiopharmaceuticals

Bacterial endotoxin content is a key quality attribute of injectable radiopharmaceuticals. Standardized methods include the rabbit method and the tritium reagent method; new detection methods include kit detection method, magnetoelastic sensor method, biosensor method, and instrumental analysis method.

Standardized methods for the detection of bacterial endotoxin in radiopharmaceuticals

The standardized methods for the detection of bacterial endotoxin in radiopharmaceuticals are roughly divided into the rabbit method and the tritium reagent method. The United States first included the rabbit pyrogen test method in the Pharmacopoeia. The side effects on animals and humans during the testing of radiopharmaceuticals by the rabbit method are huge, followed by the long detection period of the rabbit method, and most radioactive drugs have short half-lives, making it difficult to control the safety of the drug before use. Therefore, since the 1980s, the rabbit method has been gradually replaced by the bacterial endotoxin method. At present, this method is still used in the European Pharmacopoeia [99mTc] colloidal sulfur injection. Cooper et al. First applied the plutonium test method to the pyrogen inspection of radiopharmaceuticals in 1971. The plutonium test method is currently the most important method for endotoxin detection. It is fast, simple, reproducible, and highly sensitive (0.01 to 1 ng/mL). Easy to popularize and standardize the advantages, applied to the radiopharmaceutical bacterial endotoxin and other detection fields.

Radiopharmaceuticals.Figure 1. Radiopharmaceuticals.

Limulus amebocyte lysate detection kits have also been widely used, such as endpoint color development, limulus amebocyte lysate deformed cell lysate (LAL) measurement, dynamic turbidity LAL measurement, and kinetic color development LAL measurement. The Endosafe PTS detection method is a rapid quantitative kinetic color development system, which can obtain the detection results within 15 minutes. Many foreign reports have reported that it is applied to the detection of bacterial endotoxins in radioactive injection varieties, such as 123I-m-iodobenzidine and 18F, 11C, and 13N labeled radiopharmaceuticals. Some studies have reported that this method is used to detect the endotoxin of 18F-FDG injection. The comparative test shows that the method is fast and accurate. Use the PTS detector to detect the bacterial endotoxin content. The PTS card has 4 built-in channels, 1 and 3 are sample detection channels, which are parallel, including sample wells, Limulus amebocyte lysate, chromogenic substrates, and optical detection chambers; 2 and 4 are The endotoxin control channel adds a known amount of bacterial endotoxin to channels 1 and 3, and the channels 2 and 4 can be used to obtain information on the reference coefficient of variation and system recovery. The PTS detector currently provides a fast, simple, and reliable method for the detection of bacterial endotoxin content in radiopharmaceutical injections. Application in radioactive injections can detect bacterial endotoxins in time before administration to ensure drug safety.


In order to prevent the harm of bacterial endotoxin to humans and animals, with the continuous research and development, more and more detection methods of bacterial endotoxin are available, but different methods have different advantages and disadvantages. Higher, better selectivity, but there are shortcomings such as more restrictive conditions or poor anti-interference, tedious operation process; and the new detection methods also have problems of cost, convenience, popularity and standardization. In response to the real-time, fast, convenient, and standardized needs of radiopharmaceuticals, there is still a lot of room for development. It is expected that more rapid and convenient analytical methods will be continuously discovered, which will continue to improve the quality of radiopharmaceuticals.

Our Services for endotoxin testing in radiopharmaceuticals

Creative BioMart offers a corresponding endotoxin testing service. You can purchase the corresponding endotoxin removal kit and related accessory products according to the needs of your own samples. We guarantee that all instruments, water, reagents, and consumables used in the experiment are free of endotoxins, and the experiment is conducted in a clean room to ensure that low levels of endotoxins are returned to the sample. In addition, we can also provide you with related services including:

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Project name Endotoxin testing in radiopharmaceuticals
Testing purpose Bacterial endotoxin content is a key quality attribute of injectable radiopharmaceuticals. Endotoxin detection is very important for radiopharmaceuticals.
Testing cycle 3-5 days.
Service including We provide you with raw data and test reports.
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