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Cefotaxime sodium
Chemical Name | ：Cefotaxime sodium |
Category | ：The third-generation semi-synthetic cephalosporin |
Specification | ：USP |
HS Code | ：2941.9057.00 |
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Structure Formula | ： |
CAS Number | ：38821-49-7 |
Molecular Formula | ：C16H16N5NaO7S2 |
Usage | ：Mainly used in the treatment of strains caused by the respiratory system, urinary, intestinal and biliary tract, skin and soft tissue, burns and bone and joint infections and other illnesses. |
Items | Standard |
|---|---|
Appearance | Off-white to pale yellow crystalline powder |
Solubility | Meets the requirements |
Identification | Meets the requirements |
Specific rotation | +58°~+64° |
Loss on drying | ≤3.0% |
PH | 4.5~6.5 |
Clarity of solution | Meets the requirements |
Avsorbance | ≤0.20 |
Assay of Cefotaxime(calculated on the dried basis) | 916ug/mg~964ug/mg |
Any individual impuritied | ≤1.0% |
Bacterial endotoxins | ≤3.0% |
Bacterial endotoxins | ≤0.20USP EU/mg |
Sterility | Meets the requirements |
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)