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Ropivacaine Hydrochloride
Chemical Name | ：Ropivacaine Hydrochloride |
Category | ： |
Specification | ：USP/EP |
HS Code | ：29333990.90 |
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Structure Formula | ： |
CAS Number | ：132112-35-7 |
Molecular Formula | ：C17H26N2O·HCl·（n）H2O |
Usage | ：Ropivacaine Hydrochloride is a new kind of long-acting anide class local anesthetics, whose effect can last for a long time, having acesodyne and superficial narcotism. Its pharmacological characteristics are low cardiac toxicity, obvious separation between feeling block and motional block and peripheral vascular contraction effect. So it is especially suitable for postoperative analgesia and obstetric anesthesia. |
Items | Standard |
|---|---|
Appearance | White powder |
Identification | A. Infrared Absorption A solution(1 in 100) responds to the test for Chloride |
Color | The absorbance at 405 nm and at 436nm,the absorbance at 405 nm is ont more than 0.030, and the absorbance at 436 nm is not more than 0.025. |
Clarity | Meets the requirement |
PH | 4.5~6.0 |
Ralated substances | Total impurity≤0.5% Single impurity≤0.1% Bupivacaine≤0.2% |
Enantiomeric purity | R enantiomer≤0.5% |
Water | 5.0%~6.0% |
Heavy metals | Not more than 10ppm |
Limit of 2,6-Dimethylaniline | Meets the requirement. |
Specific rotation | -6°~ -9° |
Assay | 98.5%~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)