Tamsulosin Hydrochloride API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Tamsulosin Hydrochloride API Manufacturer in India

Tamsulosin Hydrochloride is a selective alpha-1 adrenergic receptor antagonist used primarily in pharmaceutical formulations for the management of symptoms associated with benign prostatic hyperplasia (BPH). It preferentially acts on α1A-adrenoceptors in the prostate and bladder neck, helping relax smooth muscle and improve urinary flow.

Tamsulosin Hydrochloride is a small-molecule pharmaceutical API with the molecular formula C20H29ClN2O5S, molecular weight 444.97 g/mol, and CAS Number 106463-17-6.

Swapnroop offers Tamsulosin Hydrochloride API for pharmaceutical formulation, research and development, and bulk manufacturing requirements, subject to applicable quality specifications and documentation.

Tamsulosin Hydrochloride API Overview

Tamsulosin Hydrochloride is the hydrochloride salt of tamsulosin and belongs to the class of selective α1-adrenergic receptor antagonists. Its preferential affinity for α1A receptors makes it an important API for pharmaceutical products intended for lower urinary tract symptoms associated with BPH.

Tamsulosin Hydrochloride is commonly incorporated into oral modified-release pharmaceutical formulations.

Key Features

  • Selective α1A-adrenoceptor antagonist
  • Pharmaceutical-grade small-molecule API
  • Used in BPH-related formulations
  • Suitable for oral pharmaceutical formulation development
  • Available for bulk API requirements
  • Requires control of stereochemical and chromatographic purity

Chemical and Pharmaceutical Profile

Tamsulosin Hydrochloride is chemically identified as 5-[(2R)-2-[[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxybenzenesulfonamide hydrochloride.

The API contains a defined R-stereochemical configuration, making stereochemical purity an important quality attribute.

ParameterTamsulosin Hydrochloride
Chemical NameTamsulosin Hydrochloride
CAS Number106463-17-6
Molecular FormulaC20H29ClN2O5S
Molecular Weight444.97 g/mol
Chemical ClassSulfonamide derivative
Pharmacological ClassSelective α1-Adrenoceptor Antagonist
Therapeutic AreaUrology
Primary ApplicationBenign Prostatic Hyperplasia
Physical FormWhite or almost white powder
Salt FormHydrochloride

Pharmaceutical Applications of Tamsulosin Hydrochloride

Tamsulosin Hydrochloride API is primarily used for the development and manufacture of pharmaceutical products for:

  • Benign prostatic hyperplasia (BPH)
  • Lower urinary tract symptoms associated with BPH
  • Improvement of urinary flow
  • Reduction of symptoms associated with bladder outlet obstruction
  • Modified-release oral formulations
  • Pharmaceutical research and formulation development

Tamsulosin's selective α1-adrenoceptor activity helps relax smooth muscle in the prostate and bladder neck.

Quality and Analytical Testing

Tamsulosin Hydrochloride requires appropriate analytical testing for identity, assay, related substances and stereochemical purity.

Typical quality-control testing includes:

  • Identification by IR
  • Identification of chloride
  • Assay
  • Related substances
  • Optical isomer / enantiomeric purity
  • Loss on drying
  • Sulfated ash / residue on ignition
  • Heavy metals, where applicable
  • Specific optical rotation
  • Residual solvents
  • Elemental impurities, where applicable

For USP 2025, the assay specification is 98.0%–102.0%. BP/Ph. Eur. specifications use 98.5%–101.0% on the dried substance.

Tamsulosin Hydrochloride API Manufacturer in India

Swapnroop provides pharmaceutical API solutions for customers requiring Tamsulosin Hydrochloride for formulation development and pharmaceutical manufacturing.

Our supply approach focuses on:

  • Pharmaceutical-grade API
  • Consistent quality
  • Batch-to-batch quality control
  • Assay and impurity monitoring
  • Stereochemical purity
  • Analytical documentation
  • Certificate of Analysis
  • Technical documentation
  • Bulk API requirements

Tamsulosin Hydrochloride can be supplied according to applicable pharmacopoeial and customer-specific specifications.

Packaging and Storage

Tamsulosin Hydrochloride should be packaged in suitable pharmaceutical-grade, tight or well-closed containers that protect the API from moisture, contamination and environmental exposure.

Store under controlled conditions according to the applicable product specification and manufacturer's stability data.

Documentation

Documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Safety Data Sheet (SDS)
  • Batch documentation
  • Analytical data
  • Stability information, where applicable
  • Technical documentation
  • Regulatory documentation, where applicable

Why Choose Tamsulosin Hydrochloride API from Swapnroop?

Swapnroop supports pharmaceutical manufacturers and formulation developers with quality-focused API solutions. Tamsulosin Hydrochloride is supplied for pharmaceutical applications requiring control of assay, related substances and stereochemical purity.

For Tamsulosin Hydrochloride API bulk requirements, technical specifications, documentation and commercial enquiries, contact Swapnroop.

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 0.5%
Residue on Ignition NMT 0.10%
Heavy Metals NMT 20 ppm
Water Content NMT 0.5%
Melting Point About 230°
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