HyatrueTM Pharmaceutical Grade HA
HyatrueTM is a pharmaceutical grade sodium hyaluronate developed by Bloomage Biotechnology Corp.,Ltd., which can be used as an API or excipient for drugs and medical devices in ophthalmic preparations, in-articular injections, anti-adhesive preparations, topical preparations for wound healing and soft tissue filler ,etc. It includes Medical Grade Sodium Hyaluronate and Injection Grade Sodium Hyaluronate.
1.High Safety
Bacteria and raw materials for fermentation are safe:
- Non animal sources: It is produced by bacterial fermentation. All the ingredients of medium are non animal sources.
- Non GMO: The strain is widely accepted as safe and is included in EP, JP, and China National Standard.
Products are safe:
- HyatrueTM has been tested and proven safe and non toxic.
- Regulatory Compliance: Approved by the SFDA for sodium hyaluronate pharmaceutical excipient（F20040001）, sodium hyaluronate API（H20113379）, GMP Certificate（2010）, CEP Certificate, DMF, KDMF, passed on-site audit by FDA and KFDA.
2. High Purity
- Product quality of HyatrueTM is much higher than European Pharmacopoeia standard and China National Standard, with much lower impurities.
- The endotoxin of HyatrueTM tested by Charles River is less than 0.0025IU/mg.
3. High Stability
- Stability tests were conducted to prove that Hyatrue's quality is stable under its recommended storage and transportation conditions.
