Injection Grade
Hyatrue® Injection grade HA-EP1.2
1. Specification
Complies with the standard of Ph.Eur..
Intrinsic viscosity: 0.9-1.2 m3/kg/1.2-1.7m3/kg
2. Compliance and registration
| Regulatory compliance | GMP Certificate |
| ICH Q7 | |
| ISO 9001 | |
| ISO 14001 | |
| cGMP approved by US FDA and Korean MFDS | |
| Registration | CEP |
| Russia registration | |
| Form 41 from India DCGI |
3. Application
It can be used in intra-articular injections, Ophthalmic viscosurgical devices (OVD), anti-adhesive preparations, soft tissue filler, scaffold materials in tissue engineering, etc.
4. Quality Control
A. Natural and safe
It is produced by bacteria fermentation.
Non-GMO: The strain is widely accepted as safe and is included in EP, JP, and China National Standard.
B. High Purity
Quality of sodium hyaluronate HA-EP1.2 is much higher than European Pharmacopoeia standard. Impurity control is much more strict compared to EP 10.0.
C. High Stability
It is stable under its recommended storage and transportation conditions.