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 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)