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Sodium hyaluronate
Chemical Name | ：Sodium hyaluronate |
Category | ： |
Specification | ：USP |
HS Code | ：30067000.00 |
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Structure Formula | ： |
CAS Number | ：9067-32-7 |
Molecular Formula | ：C14H22NNaO11 |
Usage | ：Sodium hyaluronate is extracted from cockscomb substances, can also be made by lactic acid bacteria fermentation. It is biochemical drugs with high clinic value, widely used in various ophthalmic surgery such as crystal implantation, corneal transplantation and glaucoma surgery etc. It also can be used tocure arthritis and accelerate wound healing. |
Items | Standard |
|---|---|
Characters | White or almost white powder pr fibrous aggregate |
Identification A. Infrared absorption B. Reaction of sodium | Consistent with the Ph.Eur. Reference spectrum of sodium hyaluronate Positive |
Sodium hyaluronate | 95%~105.0% |
PH | 5.0~8.5 |
Nucleic acids | A260nm≤0.5 |
Protein | ≤0.1% |
Appearance of solution | Solution is clear A600nm≤0.01 |
Intrinstic viscosity | 2.3~2.8 m3 |
Loss on drying | ≤20.0% |
Chlorides | ≤0.5% |
Iron | ≤80ppm |
Heavy mentals | ≤20ppm |
Bacterial ebdotoxins | <0.51U/mg |
Microbial contamination Total aerobic microbial count | ≤100cfu/g |
1， Argentinian National Institute of Drugs
Instituto Nacional de Medicamentos (INAME)
2， Australian?Therapeutic?Goods?Administration (TGA)
3， Belgian Federal Agency for Medicines and Health Products
Agence Fédérale des Médicaments et des Produits de Santé(AFMPS)
Federaal Agentschap voor Geneesmiddelen enGezondheidsproducten (FAGG)
4， Canadian?Health?Products and?Food?Branch?Inspectorate(HPFBI)
5， Taiwan?Food and?Drug?Administration?(TFDA)
7， Czech State Institute for Drug Control
Státní ústav pro Kontrolu Lé?iv (SúKL)
8， Czech?Institute for?State?Control of?Veterinary?Biologicals?and?Medicines (ISCVBM)
9， Danish?Health and?Medicines?Authority (DHMA)
10， Finnish?Medicines?Agency (FIMEA)
11， French National Agency for Medicines and Health Products Safety
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
12， 13， German Federal Ministry of Health * 14， Icelandic?Medicines?Agency?(IMA) 20， Indonesian?National?Agency for?Drug and?Food?Control (NADFC) 21， Health?Products?Regulatory?Authority?(HPRA) 22， Italian Medicines Agency 23， Japanese?Pharmaceuticals and?Medical?Devices?Agency(PMDA) 24， Korea (Republic of)?Ministry of?Food and?Drug?Safety?(MFDS) 25， Malaysian?National?Pharmaceutical?Control?Bureau?(NPCB) 26， Dutch Health Care Inspectorate* 27， (Medsafe) 28， Norwegian?Medicines?Agency?(NOMA) 29， Polish?Main?Pharmaceutical?Inspectorate (MPI) 30， Romanian?National?Agency for?Medicines and?MedicalDevices (NAMMD) 31， South African?Medicines?Control?Council?(MCC) 32， Spanish Agency of Medicines and Medical Devices?* Agencia Espa?ola de Medicamentos y Productos Sanitarios(AEMPS) 33， Swedish?Medical?Products?Agency?(MPA) 34， (MHRA) 36， U.S.?Food and?Drug?Administration (US FDA) 37， European Directorate for the Quality of Medicines & HealthCare （EDQM） 38， European Medicines Agency（EMA） 39， World Health Organization（WHO）
Bundesministerium für Gesundheit (BMG)
Agenzia Italiana del Farmaco (AIFA)
Inspectie voor de Gezondheidszorg (IGZ)