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Griseofulvin
Chemical Name | ：Griseofulvin |
Category | ：Antifungal |
Specification | ：CVP |
HS Code | ：29419090.00 |
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Structure Formula | ： |
CAS Number | ：126-07-8 |
Molecular Formula | ：C17H17ClO6 |
Usage | ：Can inhibit fungal mitosis, make the mitotic spindle structure fracture, terminate the metaphase cell division. |
Items | Standard |
Appearance | A white or yellowish-white ,microfine powder |
Particle size | The particles of whice are generally up to 5um in max dimensicn Larger particles whice may occasionally exceed 30um |
Melting point | About 220℃ |
Identification | The infrared absorbance spectrum is concordant with the reference spectrum A wine-red color deveiops |
Appearance of solution | The solution is clear and not more intensely coloured than reference solution Y4 |
Acidity | Not more than 1.0 ml of 0.02M sodium hydroxide required |
Specific optical rotation | +354°to +364° |
Related subhstances | -CI:<0.60 -H:<0.15 |
Residual solvents | Ethanol ≤0.5% Acetol ≤0.5% Dichloromethane ≤0.06% |
Substance soluble in light petroleum | ≤0.2% |
Loss on drying | ≤1.0% |
Sulfated ash Abnormal toxicity Assay(dried substance) | ≤0.2% Five mice orais ,none of the mice dies within 48h 97.0% to 102.0% |
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 Léčiv (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， French Agency for Food, Environmental & Occupational Health Safety
Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES)
13， German Federal Ministry of Health *
Bundesministerium für Gesundheit (BMG)
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
Agenzia Italiana del Farmaco (AIFA)
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*
Inspectie voor de Gezondheidszorg (IGZ)
27， New Zealand's Medicines and Medical Devices Safety Authority (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 Española de Medicamentos y Productos Sanitarios(AEMPS)
33， Swedish Medical Products Agency (MPA)
34， United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA)
35， United Kingdom's Veterinary Medicine Directorate (VMD)
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）