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Celecoxib
Chemical Name | ：Celecoxib |
Category | ：A new generation of non-steroidal anti-inflammatory analgesic |
Specification | ：EP/USP |
HS Code | ：2935.0090.90 |
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Structure Formula | ： |
CAS Number | ：169590-42-5 |
Molecular | ：C17H14F3N3O2S |
Usage | ：This product has good anti-inflammatory analgesic, to protect the gastric mucosa, to maintain renal blood flow, regulation of platelet aggregation effect, but also solve the common NSAIDs are gastrointestinal irritation. |
Items | Standard |
|---|---|
Appearance | White to off-white crystalline powder |
Identification | A.The infrared absorption spectrum should meet with the reference spectrum B.The retention time of sample major peak should meet with the retention time of reference substance major peak. |
Related substances | Related Compound A≤0.4% Related Compound B≤0.1% Individual unspecified impurity≤0.1% Total impurities≤0.5% |
Residual solevents | Ethanol≤0.5% Ethyl trifluoroacetate≤0.5% |
Particle Size | < 100 MICRON |
Water | ≤0.5% |
Residue On Ignition | ≤0.2% |
Heavy Metal | ≤20ppm |
Assay | 98.0%-102.0% |
Microbiological | AEROBIC MICROORGANISM MAX 30 CFU/GR MOULD AND YEAST MAX 10 CFU /GR FREE OF PATHOGENS |
Bacterial endotoxins | ≤0.20USP EU/mg |
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）