Microbiological Test

Medicilon can provide clients with method development, validation and testing of microorganisms and bacterial endotoxins for APIs and different types of drug products. Bacterial endotoxins are cell wall components of gram-negative bacteria that are released when the bacteria die or autolyse. Its lipopolysaccharide (LPS) amphoteric macromolecule component is highly thermogenic. When endotoxin enters the human blood through injection or other methods, it can cause different diseases. In severe cases, it can cause shock or even death (pyrogen reaction). Therefore, pharmaceutical companies need to control bacterial endotoxins in all aspects including raw materials, packaging materials, original solutions, semi-finished products and finished products. The bacterial endotoxin test (BET) is a method that uses lysate reagent to detect or quantify bacterial endotoxins to determine whether the limit of bacterial endotoxins in the test product meets the regulations. Including gel method (limit test, semi-quantitative test), photometric method (turbidity method, chromogenic matrix method), any one of these methods can be used for testing. When the measurement results are controversial, the results of the gel method shall prevail unless otherwise specified. Medicilon has established a mature process for endotoxin testing and has completed endotoxin testing, method development and validation for hundreds of new drugs and generic drugs worldwide. The project cycle is short, fast and accurate, and it is widely praised by clients.