Hyaluronidase

Hyaluronidase is an enzyme that catalyses the hydrolysis of hyaluronic acid. Native hyaluronidase is extracted from mammalian testes. 

Storage: Store in an airtight container, at a temperature of 2℃ to 8℃.

Description

Production process

Linzyme Hyaluronidase is purified by affinity chromatography. Our hyaluronidase is suitable for Active Pharmaceutical Ingredient (API) in accordance with the European Union good manufacturing practice (GMP), meeting the requirements of the European Pharmacopoeia (EP).

Linzyme Hyaluronidase as an API is registered in the Korean Ministry of Food and Drug Safety, and is used in Korean market.

Product usage

Hyaluronidase has been used in medical applications for over 60 years. The US Food and Drug Administration approved indications are (1) for subcutaneous fluid infusion, (2) to increase absorption and dispersion of drugs in subcutaneous tissue and to manage extravasation, and (3) to promote the absorption of radiopaque agents in urinary tract angiography. Hyaluronidase has also been approved and used for the purpose of increasing hematoma absorption in Europe. In addition, with the increasing popularity of hyaluronic acid filler, hyaluronidase has become an essential drug to dissolute misplaced fillers and to treat complications after injections. 

Specifications

Spec1

ItemSpecificationMethod
AppearanceWhite or yellowish-white, amorphous powder
pH4.5 – 7.5EP
Loss on drying≤ 5.0%EP
Bacterial endotoxinsLess than 0.2 IU per IU of hyaluronidaseEP
Activity≥ 300 IU/ mg powderEP


Customized Specifications

Other specifications can be customized according to customers’ requirements.