Tamsulosin Hydrochloride (Tamsulosin HCl) is a selective α1A-adrenoceptor antagonist used primarily in the management of the symptoms of benign prostatic hyperplasia (BPH). It selectively relaxes smooth muscle in the prostate and bladder neck, helping improve urinary flow and reduce symptoms associated with BPH.
Tamsulosin Hydrochloride has the molecular formula C20H29ClN2O5S, molecular weight 445.0 g/mol, and CAS Number 106463-17-6.
Swapnroop offers Tamsulosin HCl API for pharmaceutical formulation, development and bulk manufacturing requirements, subject to applicable specifications and quality documentation.
Tamsulosin Hydrochloride is the hydrochloride salt of the active R-enantiomer of tamsulosin. It belongs to the quinazoline-free sulfonamide class of selective alpha-adrenergic receptor antagonists and has preferential activity at α1A receptors.
The API is used in pharmaceutical formulations designed to manage lower urinary tract symptoms associated with benign prostatic hyperplasia.
Tamsulosin Hydrochloride is chemically identified as 5-[(2R)-2-[2-(2-ethoxyphenoxy)ethylamino]propyl]-2-methoxybenzenesulfonamide hydrochloride. Its stereochemical identity is important because pharmaceutical Tamsulosin HCl is the R-enantiomer.
The USP monograph specifies Tamsulosin Hydrochloride at 98.5%–101.0% on the dried basis and includes controls for loss on drying, related substances and enantiomeric purity.
Tamsulosin HCl API is primarily used for pharmaceutical products intended for:
Tamsulosin is generally formulated as an oral dosage form, including modified-release formulations.
Quality testing for Tamsulosin Hydrochloride includes chemical identity, assay, stereochemical purity, related substances and physical quality attributes.
Important analytical parameters include:
The USP monograph specifies 98.5%–101.0% assay, NMT 0.5% loss on drying, NMT 0.10% individual impurity, NMT 0.20% total impurities, and NMT 0.3% optical isomer. It also specifies specific rotation of −17.5° to −20.5° at 20°C.
Swapnroop provides pharmaceutical API solutions for customers requiring Tamsulosin Hydrochloride for formulation development and commercial pharmaceutical manufacturing.
Tamsulosin HCl can be supplied according to applicable quality specifications and customer requirements, with appropriate analytical and technical documentation.
Key supply considerations include:
Tamsulosin Hydrochloride should be stored in tight containers under controlled room-temperature conditions as specified by the applicable pharmacopoeial or manufacturer specification.
Suitable pharmaceutical-grade packaging should protect the API from contamination, moisture and environmental exposure.
Depending on customer and regulatory requirements, documentation may include:
Swapnroop provides pharmaceutical API solutions focused on quality, analytical compliance and reliable supply for formulation and manufacturing requirements.
Tamsulosin Hydrochloride is supplied for pharmaceutical applications with attention to assay, related substances, enantiomeric purity and other applicable quality attributes.
For Tamsulosin HCl API bulk requirements, specifications, documentation and commercial enquiries, contact Swapnroop.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.20% |
| Water Content | NMT 0.5% |
| Melting Point | −17.5° to −20.5 |