Key Properties of Hydrochlorothiazide
| Product Name: | Hydrochlorothiazide |
| Synonyms: | 6-chloro-1,1-dioxo-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide |
| CAS No: | 58-93-5 |
| Chemical Formula: | C₇H₈ClN₃O₄S₂ |
| Grade: | USP |
| Appearance: | White to off-white crystalline powder |
| Molar Mass: | 297.74 g/mol |
| Solubility: | Sparingly soluble in water |
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BroucherManufacturing process of Hydrochlorothiazide
The manufacturing process begins with ensuring equipment cleanliness and availability of utilities, raw materials, and packing materials.
Charge water or ethanol is into the Glass line reactor (GLR) and add intermediate compounds and reagents. Stir the reaction mass for 10-15 min. and heat the reaction mass up to 80–90°C and maintain the reaction mass temperature 80–90°C for 240–360 minutes. Take the in-process sample from reactor and send the in-process sample to Quality control (QC) for reaction monitoring by HPLC.
After in-process result complies, cool the reaction mass up to 20–25°C, and an anti-solvent is added to crystallize the product. The product is filtered and washed with chilled solvent to remove impurities.
Drying is conducted in a vacuum dryer at 50–60°C for 480–600 minutes. The dried material is milled and sieved to ensure uniform particle size.
Pack Hydrochlorothiazide in a clear poly bag and twist the mouth of the bag. Secure it with a PVC strip. Place this bag inside another poly bag, twist its mouth, and secure it with a PVC strip. Insert these bags into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Hydrochlorothiazide in a tightly closed, light-resistant container at a temperature of 20°C to 25°C.
Applications of Hydrochlorothiazide
Technical Specifications of Hydrochlorothiazide
| Sr.No. | Test | Specification |
|---|---|---|
| 1 | Description | White to off-white crystalline powder |
| 2 | Solubility | Very slightly soluble in water, soluble in acetone, sparingly soluble in ethanol; it dissolves in dilute alkali hydroxide |
| 3 | Identification | A) By IR: Infrared absorption spectrum obtained from the sample should correspond to the Hydrochlorothiazide reference standard spectrum. B) By UV: Should comply |
| 4 | Chloride and Sulphate | Should comply |
| 5 | Selenium | Not more than 30 ppm |
| 6 | Loss on Drying | Not more than 0.5% |
| 7 | Residue on Ignition | Not more than 0.1% |
| 8 | Related Substances by HPLC | A) Benzothiadiazine: Not more than 1.00% B) Cholorothioazide: Not more than 0.50% C) 5-Chlorohydrochlorothiazide: Not more than 0.50% D) Hydrochlorothiazide Dimer: Not more than 0.50% E) Any Individual Impurity: Not more than 0.50% F) Total Impurities: Not more than 0.90% |
| 9 | Assay by HPLC (on anhydrous basis) | Not less than 98.0% w/w to not more than 102.0% w/w |
Packing and Storage condition of Hydrochlorothiazide
Pack Hydrochlorothiazide in a clear poly bag and twist the mouth of the bag. Secure it with a PVC strip. Place this bag inside another poly bag, twist its mouth, and secure it with a PVC strip. Insert these bags into a triple-laminated aluminum bag and seal it properly. Finally, place the sealed aluminum bag in an HDPE container. Store Hydrochlorothiazide in a tightly closed, light-resistant container at a temperature of 20°C to 25°C.
Why Choose Chemignition for
Hydrochlorothiazide Supply?
Quality Assurance
Grade Compliance
Hydrochlorothiazide is manufactured in adherence to stringent global pharmaceutical standards.
In-House Quality Control
Each batch undergoes rigorous testing for purity, stability, and efficacy.
Regulatory Approvals
Certified for export and compliant with international regulatory requirements.
Large-Scale Manufacturing and Export
Grade Compliance
Hydrochlorothiazide is manufactured in adherence to stringent global pharmaceutical standards.
In-House Quality Control
Each batch undergoes rigorous testing for purity, stability, and efficacy.
Regulatory Approvals
Certified for export and compliant with international regulatory requirements.
