Naproxen
Chemical Name | ：Naproxen |
Category | ：Antipyretic-analgesic and Anti-inflammatory |
Specification | ：USP/EP |
HS Code | ：29189900.90 |
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Structure Formula | ： |
CAS Number | ：22204-53-1 |
Molecular Formula | ：C14H14O3 230.26 |
Usage | ：The product is PG synthetase inhibitor having anti-inflammatory, antipyretic and analgesic effect. It has positive effect on Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout and motor system (such as joints, muscles and tendons) of chronic degenerative diseases and mild and moderate pain such as dysmenorrhea. Medium-degree pain can be relieved in 1 hour after taking the drug, whose abirritation can up to 7 hours. Its curative effect is similar to aspirin on the treatment of rheumatoid arthritis and osteoarthritis. For patient who can’t tolerance anti-inflammatory analgesic (such as aspirin, indomethacin) because of Anemia, gastrointestinal system disease or other reasons, using this product can usually get satiafactory effect. |
Items | Standard |
|---|---|
Appearance | White or almost white, crystalline powder |
Solubility | Practically insoluble in water, soluble in rthanol(96%) and in methanol |
Identification Specific optical rotation Melting point Infrared absorption | +59°~+62° 154℃~158℃ Positive |
Appearance of solution | Clear, not more intensively colored than reference solution BY7 |
Enantiomeric Impurities Impurity G | ≤2.5% |
Ralated substances Impurity L Impurity O Any other impurity Total impurities | ≤0.15% ≤0.15% ≤0.10% ≤0.3% |
Heavy Metals | ≤20ppm |
Loss on drying | ≤0.5% |
Sulphated ash | ≤0.1% |
Assay (titration, on dried substance) | 99.0%~101.0% |
Residual solvent Methanol Toluene | ≤50ppm ≤45ppm |
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 Léčiv (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， French Agency for Food, Environmental & Occupational Health Safety
Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES)
13， German Federal Ministry of Health *
Bundesministerium für Gesundheit (BMG)
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
Agenzia Italiana del Farmaco (AIFA)
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*
Inspectie voor de Gezondheidszorg (IGZ)
27， New Zealand's Medicines and Medical Devices Safety Authority (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 Española de Medicamentos y Productos Sanitarios(AEMPS)
33， Swedish Medical Products Agency (MPA)
34， United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA)
35， United Kingdom's Veterinary Medicine Directorate (VMD)
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）