Injection Grade
Hyatrue® Injection grade HA-EP-N1.8
1. Specification
Complies with the standard of Ph.Eur.10.0
Intrinsic viscosity: 1.6-2.2 m3/kg
2. Compliance and registration
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Regulatory compliance |
GMP Certificate |
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ICH Q7 |
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ISO 9001 |
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ISO 14001 |
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cGMP approved by US FDA and Korean MFDS |
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Registration |
CEP（In progress） |
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Russia registration |
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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-EP3.0 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.