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Description:
Sodium Hyaluronate, which is a polymer polysaccharides of biological materials formed by N-acetyl glucosamine and glucuronic acid through iterative connected, has a high degree of viscoelasticity, plasticity, permeability and good biocompatibility. This product is manufactured with raw material of comb based on the process of fine biochemical technology, separation, purification and refining. The gel contains 1% HMW of sodium hyaluronate and physiological buffer. This product, which is a colorless, odorless, sterile, pyrogen free transparent viscous liquid, adopts the aseptic processing technology to filter sterilization.
Function:
1. Moist eyeball surface during surgery, and prevent epithelium from dry. The function of this product is much better than physiological saline or equilibrium liquid.
2. Inject this product under bulbar conjunctiva to separate conjunctival flap, and minimized the post-operative sub-conjunctive-fibrosis during glaucoma surgery.
3. Form protective layer to reduce the damage of device or intraocular lens implantation to endothelial cell, and reduce loss rate of endothelial cell.
4. Convenience to operation, such as extraction of foreign body in anterior chamber, intraocular lens implantation
Indication:
1. Cataract surgery
2. Corneal transplant
3. Glaucoma surgery
4. Retinal detachment surgery
5. Phacoemulsification
6. Ocular surgery
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Sodium Hyaluronate Gel (Ophthalmology Viscoelastic) COA |
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Source: Fermented |
Quantity: 5000pcs |
Manufacturing Date: 13 May, 2011 |
Category: Eye Surgery Viscoelastic |
Specification: 1.60%HA 1ml/syringe |
Batch No.: HT11051309 |
Test Items |
Standard |
Result |
Appearance |
Colorless, Transparent viscous liquid, |
Complies |
Centration |
…………… |
1.60% |
Sodium Hyaluronate % |
90.0% ~ 120.0% |
97.20% |
PH |
6.8 ~ 7.5 |
6.95 |
Solution transmittance |
≥99.0% |
99.7 |
Heavy metal |
<;10ppm |
Complies |
Protein |
<;0.1% |
0.03 |
Molecular weight |
>1.8 X 106 |
1.89 x 106 |
Osmotic pressure |
270mOsmol/L ~ 350 mOsmol/L |
290 mOsmol/L |
Dynamic viscosity |
>10000mPa.s |
270000 mPa.s |
Value of UV absorption at 260nm |
<;1.0 |
Complies |
Value of UV absorption at 280nm |
<;1.0 |
Complies |
Sterile |
Sterile |
Complies |
Endotoxin |
<;0.5EU/mg |
Complies |
Shelf Life |
Two Years |
|
Conclusion |
YY0308-2004 |
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ANALYST: 06 |
|
VERIFIER: 08 |
