|
|
| Place of Origin | China |
| Brand Name | HS |
| Certification | GMP; ISO |
| Model Number | EP |
Injectable Hyaluronic Acid Powder EP7.0 Pharmaceutical Grade For Drug Production
What is pharma grade sodium hyaluronic acid ?
Hyaluronic acid (HA) is a straight chain macromolecular mucopolysaccharide composed Of repeat disaccharide units of glucuronic acid and N-acetylglucosamine. The commercial HA is commonly a sodium salt, called sodium hyaluronate, habitually called hyaluronic acid. Its molecular weight is from several ten thousand to several million. It's aqueous solution has outstanding moisture keeping ability, high viscoelasticity and lubricity. It is widely used in cosmetics, pharmacy and health and beauty food.
Pharmaceutical Grade sodium Hyaluronic acid is the sodium hyaluronate utilized as a part of medications. This is an oral evaluation utilized for parenteral arrangements, yet excluding intra-articular and intra-visual preparations.It is typically utilized as a part of the oral or topical outside medications, for example, the blaze salve, oral tablet.
The detailed specification of Pharma Grade sodium hyaluronic acid:
|
Produdct Name |
Sodium Hyaluronate |
|
Quality Standard |
EP 7.0, Pharma Grade |
|
Origin |
Baterial Fermentation |
|
Intended Use |
For the production of oral or parenteral preparations, not including intra-articular and intra-ocular preparations |
|
Apperance |
white or almost white powder or fibrous aggregate |
|
ITEMS |
Acceptance Criteria |
|
Charater |
White or almost white powder or fibrous aggregateq
|
|
Identification |
|
| A. Infrared Absorption | complies with the Ph. Eur. Reference spectrum of sodium hyaluronate |
|
B. Reaction of sodium |
Postive |
|
Apperance of solution |
Clear A600nm ≤0.01 |
|
pH |
5.0~8.5 |
|
Intrinsic viscosity |
1.2-2.8 m³/kg |
|
Nucleic Acids |
A260nm ≤ 0.5 |
|
Protein |
≤0.1% |
|
Chlorides |
≤ 0.5% |
|
Iron |
≤30 ppm |
|
Heavy metals |
≤ 10 PPM |
|
Loss on drying |
≤ 20.0% |
|
Microbial contamination(TAMC) |
≤ 100cfu/g |
|
Bacterial endotoxins |
＜0.05IU/mg |
| Residual Solvents (Ethanol) |
≤ 5000ppm |
|
Assay |
95.0%~105.0%
|
What is the Application of pharmaceutical Grade Sodium Hyaluronic Acid ?
Injectable Grade sodium hyaluronic corrosive is utilized as a part of the Ophthalmic viscosurgical devices,Intra-articular infusion, Anti-cement items or dermal filler. It is utilized as a part of medicinal applications in various capacities, for example, to decrease irritation, ease the torment in joints or reestablish the liquids, and ensure against the breakdown of ligaments.
The type of pharmaceutical items that containing sodium hyaluronate incorporates:
1. Ophthalmic viscosurgical gadgets
2. Intra-articular infusion
3. Hostile to cement items
4. dermal filler
What is the advantage of our company:
2008-- A GMP workshop (300,000 clean class) was built and put into service. It was upgraded to 100,000 clean class in 2011
2010 May -- Received the Drug Manufacturing License issued by the State FDA. It was renewed on October 22, 2014 and valid until October 21, 2019
2010 October --ISO9001 & ISO 22000 Verified. It was renewed on Oct.11, 2018 and valid until October 11, 2021.
2012 April --Pass the FDA site inspection with zero inspectional observation.
2012August --Received the NSF-GMP certificate and listed as a GMP manufacturer of dietary supplements on NSF website and renew the certificate every year.
2012 September--- Register our plant at EU Commission as an animal by products manufacture, the approval number is 3300DZ0091 .
2012 December –DMF NO. of Chondroitin Sulfate received from USFDA: 26474.
2014 March--- MSC Verified for Shark Chondroitin and Shark Cartilage Powder. It was renewed on March 2, 2017 and valid until March 1, 2020.
2016 March---HALAL Verified. It was renewed on March 30, 2016 and valid until March 29,
Pictures of our company:
Contact Us at Any Time
