Water for injection (WFI) is pharmaceutical purified water that is further purified by distillation, which removes bacterial endotoxins from the water. Water for injection is mainly used for products or processes that come into direct contact with blood. Therefore, it is vital to control and monitor the levels of endotoxins, as endotoxin levels cause a pyrogen response when introduced into the blood.
Legal requirements for compliance with pharmaceutical water specifications are defined in the Pharmacopoeia. These water specifications can be found in the following pharmacopeias: USP, Ph Eur and JP. These documents identify the minimum quality standards that can be enforced by regulators in the industry. Creative BioMart is responsible for ensuring the highest level of operational control to ensure patient product safety. The additional risks and additional testing associated with WFI can be attributed to the product management approach.
Creative BioMart's serum endotoxin test mainly uses limulus amebocyte lysate test, which is a kind of arthropod. Amebocytes in the blood contain factor C, factor B and proclottin-gEnzyme, which can be activated by endotoxin. The activated coagulase can make the coagulation in the deformed cells coagulagen is coagulated to form coagulated proteins, which can be used for qualitative, semi-quantitative and quantitative determination of endotoxin. The reaction has high sensitivity (pg/ml) and specificity. It can be divided into gel method, turbidity method and color matrix method.
The glass equipment used in the experiment should be fully washed, washed with purified water, and then placed in dry heat at 250 °C for 2 h. Take one bacterial endotoxin working standard (100 EU/piece), add 1 mL of pyrogen-free water, and mix on a vortex mixer for 15 min. Take 0.1 mL plus 0.9 mL of pyrogen-free water to make a 10 EU·mL-1 dilution, and then take 0.1 mL of diluted solution and 0.9 mL of pyrogen-free water to make a 1 EU·mL-1 dilution. The specific dilution is 0.25, 0.125, 0.0625, 0.03 EU · mL-14 series of standard endotoxin dilutions. Each dilution is placed in a vortex mixer and shaken for 3 minutes.
Figure 1. Workflow. (Creative BioMart)
|Project name||Endotoxin testing in water for injection|
|Testing purpose||Water for injection will directly contact human tissues and organs, so endotoxins must be tested before use.|
|Testing cycle||3-5 days.|
|Service including||We provide you with raw data and test reports.|
To meet the challenging requirements, Creative BioMart has built a team of experienced scientists with facilities and processes designed specifically to offer corresponding endotoxin testing services. You can also purchase the corresponding endotoxin removal kit and related accessories according to your sample needs. 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:
If you are interested in our services, please contact us for more details.