Hydrochlorothiazide
Chemical Name | ：Hydrochlorothiazide |
Category | ： |
Specification | ：EP/USP |
HS Code | ：30049090.99 |
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Structure Formula | ： |
CAS Number | ：58-93-5 |
Molecular Formula | ：C7H8ClN3O4S2 |
Usage | ：Hydrochlorothiazide is diuretic and antihypertensive drug. It is mainly suitable for cardiogenic edema, liver edema and kidney edema such as nephrotic syndrome, acute glomerulonephritis, chronic renal failure, and adrenal cortical hormone and estrogen edema caused by overmuch adrenal cortical hormone and estrogen, also for high blood pressure and diabetes insipidus. Long-term application should supplement calcium appropriately. |
Items | Standard |
|---|---|
Appearance | White, or practically white, practically odorless, crystalline powder. |
Solubility | Slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. |
Identification | IR absorption UV absorption |
Loss on drying | ≤0.5% |
Residue on ignition | ≤0.1% |
Chloride | ≤0.035% |
Selenium | ≤0.003% |
Heavy metals | ≤0.001% |
Organic volatile impurities | Organic volatile impurities |
Related compounds | Benzothiadiazine related compound A ≤1.0 % Any other impurities≤0.5 % Total other impurities ≤0.9 % |
Assay | 98.0%-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 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）