Florfenicol
Chemical Name | ：Florfenicol |
Category | ：Antibacterial |
Specification | ：CVP |
HS Code | ：3004.2090.12 |
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| Structure Formula | ： |
| CAS Number | ：73231-34-2 |
| Molecular Formula | C12H14Cl2FNO4S |
| Usage | ：Animal is special antibacterial drug, used in pigs caused by sensitive bacteria;Chicken and fish bacterial disease, especially to the respiratory system infection and intestinal infection curative effect is distinct |
Items | Standard |
|---|---|
Appearance | White or almost white crystalline powder |
Melting point | 152~156℃ |
Specific optical rotation | -16~-19° |
Identification | A)The retention time of the major peak in the chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation obtained as specified in the assay B)IR:Conforms to the reference spectra |
pH | 4.5~6.5 |
Clarity of solution | Not more than reference suspension Ⅱ |
Color of the solution | Not more intensely coloured than Y5 or GY5 |
Chloride | ≤0.02% |
Fluorin Content | ≥4.8% |
Relate substances(HPLC) | Any single impurity ≤ 0.5% Total impurities ≤ 2.0% |
Water | ≤0.5% |
Residue on ignition | ≤0.1% |
Heavy Metal | ≤20ppm |
Assay (On the anhydrous basis) It contains C12H14Cl2FNO4S | ≥98.5% |
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)