Medical Grade Hyaluronic acid Bulk Powder / GMP and DMF Verified Sodium Hyaluronate
Medical Grade Hyaluronic acid is different from Food grade HA. Since the Pharma HA will be applied in drugs, the manufactuer needs to be qualified with Drug GMP certificates and DMF documentation to produce such products. Our manufacturer is qualified with EU Drug GMP and DMF documentation. We supply Pharma Grade HA with good quality at a reasonable prices.
Pharma Grade HA is used to produce drugs for the treatment of joint diseases. It is also used in some skin drugs such as Ointment for Skin burn damage, or other skin drug products.
Quick Deatails of Pharmaceutical Grade Hyaluronic acid
| Material name |
Pharmaceutical Grade Hyaluronic acid |
| Origin of material |
Bacteria Fermentation |
| Color and Apperance |
White powder |
| Quality Standard |
EP Pharmaceutical Grade |
| Purity of the material |
95%-105% |
| Moisture content |
≤10% (105°for 2hours) |
| Molecular weight |
Around 1000 000 Dalton |
| Bulk density |
＞0.30g/ml as bulk density |
| Solubility |
Perfect solubility into water |
| Application |
Pharma Eye Drop, Burn Topical Ointment |
| GMP Certificate |
EU GMP Certificate |
| DMF Documentation |
Yes, DMF is available |
| Shelf Life |
2 years from production date |
| Packing |
Inner packing: Sealed Foil bag,1KG/Bag, 5KG/Bag |
| Outer packing: 10kg/Fiber drum |
Pharma Grade Hyaluronic acid and its applications:
Hyaluronic acid has the following advantages:
1. Good biocompatibility and superior chemical properties
2. Good water solubility and transparency
3. High purity
4. The pH of the aqueous solution is suitable
Because of the above advantages, sodium hyaluronate is used as a viscoelastic substance for the treatment of ophthalmic diseases, and is considered to be a safe and ideal ophthalmic surgical aid.As a raw material or auxiliary material for pharmaceuticals or medical devices, sodium hyaluronate can be used in ophthalmic preparations, intra-articular preparations, post-operative anti-adhesion agents, wound healing external preparations and soft tissue fillers. Pharma Grade HA could be further divided into eye drops and injections grades.
We Beyond Biopharma is able to supply both eye drop grade and injectable grade Hyaluronic acid.
The advantage of pharmaceutical grade Hyaluronic acid supplied by Beyond Biopharma?
1. GMP and DMF: Our manufacturer of pharmaceutical Grade Hyaluronic acid is EU GMP verified, and the DMF is available for Hyaluronic acid.
2. Complete EU Pharmacopoeia compliance: Our Pharma Grade HA complies with EP standard completely.
4. Customized Molecular weight : We provide different molecular weight of HA for your choice.
3. Competitive prices: We have direct factory prices.
Typical Specification sheet of pharma grade Hyaluronic acid / Sodium Hyaluronate
ITEMS
|
SPECIFICATIONS (TEST METHOD)
|
RESULT
|
| Appearance |
White or almost white powder or fibrous aggregate |
Conforms |
| Identification |
|
|
| A: Infrared Absorption |
Complies with Ph. EUR. Reference spectrum of sodium hyaluronate |
Comply |
| B: Reaction of sodium |
Postive |
Postive |
| Appearance of solution |
Clear and the absorbance is NMT 0.01 at 600nm |
Clear, A600nm=0.002 |
| Molecular weight |
Report the test value |
1.11x 106 Dalton |
| Assay of sodium hyaluronate |
95% -105% |
100% |
| Intrinsic Viscosity |
Report the test value |
1.87 m³/kg |
| Loss on drying |
Less than10%(USP731) |
8.5% |
| Nucleic Acid |
The absorbance is NMT 0.5 at 260nm |
0.06 |
| PH (1%H2O solution) |
5.0-8.5 (0.5% solution) |
6.5 |
| Protein |
≤0.1% (on the dried substance) |
0.03% |
| Chlorides |
≤0.5% |
＜0.5% |
| Heavy Metal |
NMT10 PPM |
Pass |
| Iron |
≤80 ppm(on the dried substance) |
13.6ppm |
| Residual solvents (Ethanol) |
≤0.5% |
0.008% |
| Microbial Contamination |
<100CFU/g |
<10CFU/g |
| Bacterial Endotoxins |
＜0.5IU/mg |
＜0.5IU/mg |
FAQS about Hyaluronic acids
Can I have small samples for testing purposes ?
1. Free amount of samples: we can provide up to 50 gram of hyaluronic acid free samples for testing purpose. Please pay for the samples if you want more.
2. Freight cost: We usually send the samples via DHL. If you have DHL account, please let us know, we will send via your DHL account.
What are your Ways of shipment:
We can ship both by air and be sea ,we have necessary safety transportation documents for both air and sea shipment.
What is your standard packing ?
Our standarding packing is 1KG/Foil bag, and 10 foil bags put into one drum. Or we can do customized packing according to your requirements.
Product Tags:
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Medical Grade Hyaluronic Acid Bulk Powder , GMP And DMF Verified Sodium Hyaluronate Images
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