Spectinomycin Sulfate
Chemical Name | ：Spectinomycin sulfate tetrahydrate |
Category | ：Antibiosis |
Specification | ：EP/USP/CVP |
HS Code | ：2941.9090.00 |
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Structure Formula | ： |
CAS Number | ：64058-48-6 |
Molecular Formula | ：C14H26N2O11S |
Usage | ：In the feed additive, often with Lincoln used in combination, for prevention and control of chicken mildew slurry < mycoplasma > disease effectively;To the pig diarrhea with special effects |
Items | Standard |
|---|---|
Appearance | A white or almost white powder |
Solubility | freely soluble in water, insoluble in ethanol |
Identification | A. Infrared absorption spectrophotometry B.gives reaction (a) of sulfates |
Appearance of solution | Solution S is clear and colourless |
pH | 3.8~5.6 |
Specific optical rotation | +10.0~+14.0 |
Impurity A | ≤1.0% |
Impurity D | ≤4.0% |
Impurity E | ≤1.0% |
Any other Impurity | ≤1.0% |
Total Impurities | ≤6.0% |
Water | 12.0%~16.5% |
Sulfated ash | ≤1.0% |
Assay (On the anhydrous basis) It contains C14H26N2O11S | (4R)Dihydrospectinomycin sulphate:≤2.0% Sum of contents of spectinomycin sulphate and (4R)Dihydrospectinomycin sulphate: 93.0%~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 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)