The Bacterial Endotoxins Test (BET), also referred to as the LAL test, is utilized for the identification and measurement of bacterial endotoxins. Due to the potential health and safety risks posed by bacterial endotoxins to patients, USP <85> mandates bacterial endotoxin testing to identify and quantify the presence of endotoxins originating from Gram-negative bacteria in sterile injectables. At Chromak Research, our well experienced team can perform this type of testing using regulatory standards as per USP <85>.
Services at Chromak Research
- Limulus amoebocyte lysate (LAL) has been established as the most precise and accurate technique for identifying endotoxins. Chromak Research has successfully created and enhanced a variety of LAL formulations, both quantitative and qualitative, that offer improved sensitivity, enhanced linearity, and exceptional resistance to interference. We at Chromak Research perform the Bacterial Endotoxin testing or LAL test as per USP <85> guideline.
- Our offerings consist of gel-clot, kinetic turbidimetric, kinetic chromogenic, and recombinant cascade reagent (rCR) methods. We use the necessary reagents, instruments, and software to guarantee consistent and trustworthy results in your bacterial endotoxin testing.
- In order to safeguard patient well-being, the level of bacterial endotoxins must not surpass the threshold limits outlined in USP <85>. Inhibition and enhancement testing are conducted for each bacterial endotoxin test to ensure that there are no formulation components that could interfere with the test, and that the method employed is sufficiently sensitive to yield meaningful and precise results.
Why to choose Chromak Research?
At our laboratory, we are dedicated to providing top-notch technical services for bacterial endotoxin testing. Chromak Research laboratory adheres to cGMP standards and possesses cutting-edge analytical instruments. Our experienced team is well-versed in conducting critical tests that are essential for the final product release process. We can assist in selecting the most suitable endotoxin testing technology, support product validation efforts, offer guidance on regulatory requirements, and troubleshoot any technical challenges that may arise. By putting trust on us, you can get more effectiveness and regulatory compliance of your endotoxin testing program. We also help you to achieve precision, consistency, and accuracy in your laboratory operations.