Hydroflumethiazide API Manufacturer in India

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Hydroflumethiazide API Manufacturer in India

Hydroflumethiazide is a synthetic thiazide diuretic active pharmaceutical ingredient used for its diuretic and antihypertensive properties. It promotes the renal excretion of sodium and chloride, resulting in increased urinary water excretion and a reduction in extracellular fluid volume.

Hydroflumethiazide has the molecular formula C8H8ClF3N4O4S2 and a molecular weight of 380.75 g/mol. Its CAS Number is 135-09-1.

Hydroflumethiazide API Overview

Hydroflumethiazide belongs to the benzothiadiazine class of diuretics. It acts primarily at the distal convoluted tubule of the nephron, where it reduces sodium and chloride reabsorption.

Hydroflumethiazide has historically been used in the treatment of hypertension and edema and remains relevant as a pharmaceutical reference compound and API for research and formulation development.

Mechanism of Action

Hydroflumethiazide inhibits the sodium-chloride cotransporter (NCC) in the distal convoluted tubule.

This decreases sodium and chloride reabsorption and increases the urinary excretion of sodium and water. The resulting reduction in circulating fluid volume contributes to its antihypertensive and diuretic effects.

Pharmaceutical Applications

Hydroflumethiazide API is used in:

  • Diuretic pharmaceutical formulations
  • Antihypertensive formulation development
  • Cardiovascular pharmaceutical research
  • Renal and electrolyte research
  • Pharmaceutical analytical applications
  • Research and development

Hydroflumethiazide API Manufacturing

Hydroflumethiazide is a synthetic pharmaceutical compound manufactured through controlled chemical synthesis, followed by purification, crystallization, drying and quality-control testing.

Quality testing may include identification, assay, related substances, water content, residue on ignition, residual solvents and elemental impurities according to the applicable approved specification.

Physical and Chemical Properties

Hydroflumethiazide is generally described as a white or almost white crystalline powder. It has limited aqueous solubility and contains both sulfonamide and benzothiadiazine structural features characteristic of thiazide diuretics.

Storage

Hydroflumethiazide should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.

Quality Documentation

Depending on the intended application, documentation may include:

  • Certificate of Analysis (CoA)
  • Safety Data Sheet (SDS)
  • Product specification
  • Analytical test report
  • Residual-solvent information
  • Stability information
  • Regulatory documentation

Conclusion

Hydroflumethiazide is an established thiazide diuretic API with sodium- and chloride-excreting activity. Its established pharmacological profile and defined chemical characteristics make it relevant to pharmaceutical research, formulation development and analytical applications.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
Melting Point Approximately 230–234°C (decomposition)
Solubility Practically insoluble in water; soluble in dilute alkali solutions
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