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Bacterial endotoxins are lipopolysaccharides (LPS) found in the outer membrane of gram-negative bacteria. These substances can trigger an immune response in humans, leading to fever, inflammation, and in severe cases, septic shock. Therefore, bacterial endotoxin testing is an essential microbiological testing item, and is also a crucial quality control measure and a mandatory step in the pharmaceutical industry. It not only can ensure the safety and efficacy of pharmaceutical products, but also help prevent contamination and ensures compliance with industry standards. At our company, we offer bacterial endotoxin testing services to pharmaceutical companies. Our team of experienced scientists uses state-of-the-art equipment and reliable methods to accurately assess endotoxin levels in pharmaceutical products with quick turnaround times, competitive pricing, and exceptional customer service.
As a leading provider in the pharmaceutical industry, we offer our clients a comprehensive range of services related to bacterial endotoxin testing. Our services extend to the development, validation, and execution of methodologies for the detection of bacterial endotoxins in active pharmaceutical ingredients, various finished dosage forms, as well as raw materials like excipients, packaging materials, intermediates, and finished products, which aim to meet the stringent regulatory requirements set forth by authorities such as the FDA and EMA. At present, we have completed hundreds of new drugs and generic drugs endotoxin detection, method development and verification, with short cycle, fast speed, high accuracy.
At our company, we main use Limulus Amebocyte Lysate (LAL) testing methods to accurately detect and quantify bacterial endotoxins in various pharmaceutical products. LAL is the most common method used for bacterial endotoxin testing. This sensitive and specific test utilizes the enzymatic reaction of LAL with bacterial endotoxins to determine the endotoxin levels. At our company, we provide various options including gel clot, chromogenic method, kinetic chromogenic and kinetic turbidimetric assays for this method.
Gel clot method
In this method, a specified volume of the sample to be tested is mixed with LAL reagent in a test tube. The tube is then incubated at a specified temperature for a specified period of time. If endotoxins are present in the sample, they will activate the LAL reagent, resulting in the formation of a gel clot. The time taken for the gel clot to form is indicative of the level of endotoxins in the sample. It is a qualitative or semi-quantitative method.
Chromogenic method
In this method, the LAL reagent is added to the test sample and then adding a substrate that produces a colored product in the presence of endotoxins. The intensity of the color produced is proportional to the concentration of endotoxins in the sample, allowing for quantitative analysis.
Kinetic chromogenic method
In this method, a specified volume of the sample to be tested is mixed with LAL reagent in a microplate. The microplate is then placed in a spectrophotometer, which measures the absorbance of the solution at a specified wavelength over time. If endotoxins are present in the sample, they will activate the LAL reagent, resulting in the production of a colored product that can be detected by the spectrophotometer. The rate of increase in absorbance is proportional to the level of endotoxins in the sample.
Kinetic chromogenic method
In this method, a specified volume of the sample to be tested is mixed with LAL reagent in a cuvette. The cuvette is then placed in a turbidimeter, which measures the turbidity of the solution at a specified wavelength over time. If endotoxins are present in the sample, they will activate the LAL reagent, resulting in the formation of a turbid solution. The rate of increase in turbidity is proportional to the level of endotoxins in the sample.
Additionally, we offer cutting-edge alternatives such as recombinant Factor C (rFC) assays for more accurate and sensitive detection.
In conclusion, our bacterial endotoxin testing service is instrumental in upholding the quality and safety of pharmaceutical products. By entrusting your testing needs to our specialized laboratory, you can rest assured that your products meet regulatory requirements and uphold the highest standards of quality control. Contact us today to learn more about how we can assist in safeguarding the integrity of your pharmaceutical formulations.
It should be noted that our service is only used for research, not for clinical use.
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