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Pregabalin
Chemical Name | ：Pregabalin |
Category | ： |
Specification | ：USP |
HS Code | ：29224919.90 |
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Structure Formula | ： |
CAS Number | ：148553-50-8 |
Molecular Formula | ：C8H17NO2 |
Usage | ：The drug is one of the most promissing drug in th e development of epilepsy drugs, whose curative effect is better and the drug delievy is more convenient. It can also be used in the treatment of pain and anxiety, such as post-herpetic neuralgia. |
Items | Standard |
|---|---|
Characters | White to off-white crystalline powder |
Identification-IR | IR soectrum is consistent with reference standard |
Specific rotation | +8.5°~ +12° |
PH | 6.0-8.0 |
Residue on Ignition | ≤0.5% |
Loss on drying | ≤0.5% |
Chloride limited | ≤0.5% |
Heavy metals | ≤20ppm |
Ralated compounds Monoamide Lactam Other unspecified impurity Total imprities | ≤0.10% ≤0.10% ≤0.10% ≤1.0% |
Residue solvents Isopropanol Chloroform | ≤3.0% ≤0.006% |
Enantioeric R-pregabalin | ≤0.15% |
Assay | ≥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)