Active Member
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Address: No.40-1004, West Zone of TusPark, Suzhou Industrial Park, Suzhou City.
Contact name:Noah Chen
SUZHOU MHW CHEMICAL CO., LTD. |
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Fermentation Manufactured Sodium Hyaluronate Powder For Eye-Drops
Advantages
1. High Safety
a. 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 Standard.
b. Products are safe
Eye-drops Grade Sodium Hyaluronate has been tested and
proven safe and non toxic.
c. High Purity
Product quality of Sodium Hyaluronate is much higher
than EP standard, with much lower impurities.
The endotoxin of Sodium Hyaluronate is less than
0.5IU/mg.
d. High Stability
Stability tests were proven that product's quality is
stable under its recommended storage and transportation conditions.
Eye-drops grade sodium hyaluronate 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.
Sodium Hyaluronate (Eye-drops Grade) | |
| Test Items | Specifications |
| Appearance | White powder |
| pH | 6.0~7.5 |
| HA Assay (on dry basis) | 95.0%~105.0% |
| Molecular weight | (0.20~2.0)×106 |
| Intrinsic viscosity | Measured Value |
| Nitrogen | 3.0~4.0% |
| Nucleic acids | A260nm≤ 0.5 |
| Appearance of solution | A600nm≤ 0.01 |
| Purity test: | |
| - Chloride | ≤ 0.5% |
| - Heavy metals | ≤ 20ppm |
| - Iron | ≤ 80ppm |
| -Arsenic | ≤ 2ppm |
| - Protein | ≤ 0.1% |
| - Lead | ≤ 3ppm |
| Loss on drying | ≤ 10.0% |
| Residue on ignition | 15.0~20.0% |
| Microbiological purity: | |
| - Total bacterial count | < 100CFU/g |
| - Yeasts & mold | < 100CFU/g |
- Bacterial endotoxins | ≤ 0.5IU/mg |
