Ivermectin
Chemical Name | ：Ivermectin |
Category | ：Anti-parasitism |
Specification | ：EP/USP |
HS Code | ：2932.2090.90 |
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Structure Formula | ： |
CAS Number | ：70288-86-7 |
Molecular Formula | ：C48H74O14 |
Usage | ：Suitable for onchocerciasis and class round nematode and hookworm, roundworm, whipworm, pinworm infection |
Items | Standard |
|---|---|
Appearance | White or yellowish-white crystalline powder,slightly hygroscopic |
Identification | A.IR:Corresponds with that of CRS standard B.HPLC:The retention time for H2B1a and H2B1b corresponds with that of standard preparation |
Appearance of solution | Clear and not more intensely colored than BY7 |
Specific optical rotation | -17o~-20o |
Related substances | Individual impurities(RRT1.3-1.5)≤2.5% Any other individual impurities≤1% Total≤5% Disregard limit≤0.05% |
Ethanol and Formamide | Ethanol≤5.0% Formamide≤3.0% |
Heavy metal | ≤20ppm |
Water | ≤1.0% |
Sulphated ash | ≤0.1% |
Assay (On the anhydrous basis) It contains C48H74O14 | H2B1a/(H2B1a+H2B1b)≥90.0 95.0%≤H2B1a+H2B1b≤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)