Terbutaline Sulphate API Manufacturer in India

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

Terbutaline Sulphate API Manufacturer in India

Swapnroop is a pharmaceutical API manufacturer in India offering Terbutaline Sulphate API for pharmaceutical manufacturing applications. Terbutaline Sulphate is a selective beta-2 adrenergic receptor agonist used as an active pharmaceutical ingredient in medicines designed for bronchodilation and other approved therapeutic applications.

Terbutaline Sulphate is the sulfate salt of terbutaline. PubChem identifies Terbutaline Sulphate as CAS No. 23031-32-5, with molecular formula C₂₄H₄₀N₂O₁₀S and molecular weight 548.6 g/mol.

About Terbutaline Sulphate API

Terbutaline Sulphate is an established pharmaceutical active ingredient belonging to the beta-2 adrenergic agonist class. It selectively activates beta-2 adrenergic receptors, increasing intracellular cyclic AMP and producing relaxation of bronchial smooth muscle.

The API is used in pharmaceutical formulations intended for respiratory applications, particularly formulations where bronchodilator activity is required.

Terbutaline Sulphate is also recognized in British Pharmacopoeia quality-control systems; the British Pharmacopoeia Commission maintains a Terbutaline Sulfate chemical reference substance for use with the relevant pharmacopoeial monograph.

Chemical and Pharmaceutical Profile

Product Name: Terbutaline Sulphate
Common Name: Terbutaline Sulfate
CAS No.: 23031-32-5
Molecular Formula: C₂₄H₄₀N₂O₁₀S
Molecular Weight: 548.6 g/mol
Parent Compound: Terbutaline
Therapeutic Category: Bronchodilator
Drug Class: Selective Beta-2 Adrenergic Agonist
API Category: Respiratory / Bronchodilator API

The sulfate salt consists of two terbutaline molecules associated with sulfuric acid, as represented in PubChem's structural information.

Pharmaceutical Applications of Terbutaline Sulphate

Terbutaline Sulphate API is used in pharmaceutical formulations for respiratory and bronchodilator applications, including:

  • Bronchodilator formulations
  • Respiratory pharmaceutical products
  • Oral formulations
  • Inhalation-related formulations
  • Nebulizer solutions
  • Pharmaceutical products for bronchospasm
  • Other approved beta-2 agonist applications

The precise indication and dosage form depend on the applicable approved medicinal product and regulatory jurisdiction.

Mechanism of Action

Terbutaline Sulphate selectively activates beta-2 adrenergic receptors. Activation of these receptors stimulates adenylate cyclase through G-protein signaling, increasing intracellular cyclic AMP.

The resulting signaling cascade promotes relaxation of bronchial smooth muscle, producing a bronchodilatory effect. PubChem describes Terbutaline Sulphate as a beta-2 adrenergic receptor agonist with bronchodilating and tocolytic properties.

Terbutaline Sulphate Respiratory API

Terbutaline Sulphate is an important API for pharmaceutical manufacturers developing respiratory medicines. Its beta-2 adrenergic activity makes it suitable for formulations requiring bronchodilator action.

Consistent control of API identity, assay, related substances, water, residual solvents, elemental impurities, and other applicable quality attributes is important for pharmaceutical manufacturing.

Quality and Analytical Testing

Terbutaline Sulphate API should be tested using validated analytical procedures according to the applicable pharmacopoeial requirements and approved product specification.

Typical quality-control testing may include:

  • Appearance
  • Identification by IR
  • Identification by HPLC
  • Assay
  • Related substances
  • Individual impurities
  • Total impurities
  • Water content
  • Residual solvents
  • Sulphated ash / residue on ignition where applicable
  • Elemental impurities
  • pH or solution characteristics where applicable
  • Microbial quality where applicable

The British Pharmacopoeia maintains a specific Terbutaline Sulfate reference standard, supporting the use of pharmacopoeial analytical controls for this substance.

Terbutaline Sulphate API Manufacturer in India

Swapnroop focuses on pharmaceutical API manufacturing in India with an emphasis on quality control, process consistency, analytical testing, and appropriate documentation.

Our approach to Terbutaline Sulphate API manufacturing includes controlled production processes, suitable raw-material management, impurity monitoring, analytical testing, and pharmaceutical-grade handling.

Swapnroop supports qualified pharmaceutical customers seeking Terbutaline Sulphate API from India for pharmaceutical manufacturing and formulation requirements.

Packaging and Storage

Terbutaline Sulphate API should be packed in suitable pharmaceutical-grade packaging that protects the material from moisture, contamination and environmental exposure.

The API should be stored according to the applicable approved specification and stability requirements. Packaging should remain properly sealed during storage and handling.

Documentation

Depending on customer and regulatory requirements, documentation for Terbutaline Sulphate API may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Safety Data Sheet (SDS/MSDS)
  • Batch analytical documentation
  • Test reports
  • Stability documentation where applicable
  • Regulatory documentation where applicable
  • Packaging information
  • Quality and manufacturing documentation as applicable

Why Choose Swapnroop for Terbutaline Sulphate API?

  • Pharmaceutical API manufacturing expertise
  • Quality-focused manufacturing processes
  • Controlled analytical testing
  • Consistent batch quality
  • Pharmaceutical-grade production
  • Regulatory-oriented documentation
  • Appropriate packaging and handling
  • B2B pharmaceutical manufacturing support

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
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