Key Properties of Tamsulosin Hydrochloride
| Product Name: | Tamsulosin Hydrochloride |
| Synonyms: | 5-[(2R)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxybenzenesulfonamide; hydrochloride |
| CAS No: | 106463-17-6 |
| Chemical Formula: | C₂₀H₂₉ClN₂O₅S |
| Grade: | EP/USP |
| Appearance: | White to off-white crystalline powder. |
| Molar Mass: | 444.98 g/mol |
| Solubility: | Freely soluble in water |
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BroucherManufacturing process of Tamsulosin Hydrochloride
The manufacturing process begins with ensuring equipment cleanliness and availability of utilities, raw materials, and packing materials.
Charge ethanol in glass line reactor (GLR) and gradually add tamsulosin base with hydrochloric acid. Stir the reaction mass for 10-15 minutes and heat the reaction mass up to 30–40°C and maintain it for 240–360 minutes. Take in-process sample from reactor and send in-process sample to Quality control (QC) for reaction monitoring by HPLC.
After the reaction, the mixture is filtered to remove impurities. The product is then dried under vacuum at 40–50°C for 360-480 minutes.
Pack Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride in a tightly closed, light-resistant container at a temperature below 30°C.
Applications of Tamsulosin Hydrochloride
Technical Specifications of Tamsulosin Hydrochloride
| Sr.No. | Test | Specification |
|---|---|---|
| 1 | Description | White to off-white crystalline powder |
| 2 | Identification | A) Infrared (IR) Spectroscopy: The IR spectrum of the sample should match that of the reference standard. B) High-Performance Liquid Chromatography (HPLC): The retention time of the principal peak in the sample solution should correspond to that of the standard solution. |
| 3 | Assay (Content of Tamsulosin Hydrochloride) | 98.0% to 102.0% (calculated on the dried basis) |
| 4 | Loss on Drying | Not more than 0.5% |
| 5 | Residue on Ignition | Not more than 0.1% |
| 6 | Heavy Metals | Not more than 20 ppm |
| 7 | Related Substances (by HPLC) | – Individual unspecified impurity: Not more than 0.1% – Total impurities: Not more than 0.5% |
| 8 | Residual Solvents (by GC) | – Methanol: Not more than 3000 ppm – Ethanol: Not more than 5000 ppm – Dichloromethane: Not more than 600 ppm – Acetone: Not more than 5000 ppm |
Packing and Storage condition of Tamsulosin Hydrochloride
Pack Tamsulosin Hydrochloride 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 Tamsulosin Hydrochloride in a tightly closed, light-resistant container at a temperature below 30°C.
Why Choose Chemignition for
Tamsulosin Hydrochloride Supply?
Quality Assurance
Grade Compliance
Tamsulosin Hydrochloride 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
Tamsulosin Hydrochloride 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.
