Why we need to control endotoxin content in sodium hyaluronate?
Hyaluronic acid (HA) has unique biochemical and physical properties that make it an important biomaterial for several medical device applications. These include its use as ophthalmic viscoelastic device (OVD) during cataract surgery, injections to treat joints with osteoarthritis , cosmetic dermal fillers ; and also its use as anti-adhesion barriers in surgeries. However, once implanted, HA undergoes biodegradation which is frequently accompanied by inflammation of tissue. HA is often derived from animal tissue and bacteria, and may be contaminated with bacterial endotoxin. Bacterial endotoxin (lipopolysaccharides (LPS) from outer membrane of Gram-negative bacteria) can cause painful inflammation, leading to failure of the device.
Normally for medical grade sodium hyaluronate and injection grade sodium hyaluronate, we need to control the endotoxin content at a level. For example,
Injection Grade Sodium Hyaluronate: Endotoxin ≤0.05 IU/mg
Medical Grade Sodium Hyaluronate: Endotoxin ≤0.5 IU/mg