Marbofloxacin
Chemical Name | ：Marbofloxacin |
Category | ：Antibiotics |
Specification | ：EP |
HS Code | ：29349990.90 |
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Structure Formula | ： |
CAS Number | ：873945-29-0 |
Molecular Formula | ：C17H18FNO3S |
Usage | ：This product has antibacterial, wide, strong bactericidal activity, are widely distributed in the body, no cross resistance with other antibacterial drugs, etc. |
Items | Standard |
|---|---|
Appearance | Light yellow crystalline powder |
Solubility | Slightly soluble in water,sparingly soluble or slightly soluble in methylene chloride,very slightly soluble in ethanol |
Identification | Conforms to the marbofloxacin CRS |
Absorbance | ≤ 2.0 % |
Loss on drying | ≤ 0.5 % |
Sulphated ash | ≤ 0.1 % |
Heavy metals | ≤ 20ppm |
Impurities C、D、E For each impurity | ≤ 0.2% |
Impurities A、B For each impurity | ≤ 0.1% |
Any other single impurity | ≤ 0.2% |
Total impurities | ≤ 0.5% |
Residual solvents | Ethanol ≤ 5000ppm Toluene ≤ 890ppm Methylene chloride ≤ 600ppm |
Assay(On the anhydrous basis) It contains C17H18FNO3S | 99.0%~101.0% |
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 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)