Phenylephrine Hydrochloride USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Phenylephrine Hydrochloride USP/EP

High-purity pharmaceutical grade Phenylephrine Hydrochloride manufactured under stringent cGMP conditions. This sympathomimetic API is essential for decongestant therapy, particularly in nasal congestion and cold treatment, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥99.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Alpha-1 Agonist for Decongestant
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C9H13NO2·HCl
CAS Number: 61-76-7
EINECS Number: 200-522-6
Purity (HPLC): ≥99.0% (USP/EP Grade)
Physical State: White crystalline powder
Molecular Weight: 203.67 g/mol
Melting Point: 140-144°C
pH (1% solution): 4.5-6.5
Loss on Drying: ≤0.5%
Residue on Ignition: ≤0.1%
Heavy Metals: ≤10 ppm
Solubility: Freely soluble in water
Storage Conditions: Store below 25°C, dry place
Shelf Life: 3 years from manufacture date
Packaging Options: 1kg, 5kg, 25kg drums

Applications

Nasal Decongestant
Nasal Drops & Sprays
Ophthalmic Solutions
Oral Tablet Formulations
Liquid Formulations
Alpha-1 Adrenergic Agonist
Cold & Flu Treatment
Injectable Preparations
Vasopressor Applications
Blood Pressure Support
Research Applications
Regulatory Studies

Industry-Specific Grades

DRAVYOM offers specialized Phenylephrine Hydrochloride grades tailored for specific respiratory applications, ensuring optimal decongestant efficacy and regulatory compliance across diverse pharmaceutical formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥99.0% Water Content: ≤0.5% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥99.0% Related Substances: ≤1.0% Residual Solvents: EP limits Application: European market compliance
Ophthalmic Grade
Purity: ≥99.5% Sterility: Assured Pyrogens: <0.25 EU/mg Application: Eye drops
Injectable Grade
Purity: ≥99.5% Particle Size: Controlled Biocompatibility: Verified Application: IV preparations

Quality Standards

DRAVYOM's Phenylephrine Hydrochloride is manufactured under stringent cGMP protocols, meeting international respiratory drug standards including USP, EP, and FDA guidelines for decongestant applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥99.0% HPLC Purity
Advanced Analytical Testing
Alpha-1 Activity Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Phenylephrine Hydrochloride exhibits exceptional alpha-1 adrenergic agonist properties essential for decongestant applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding respiratory formulations.

Molecular Properties
Molecular Weight: 203.67 g/mol
LogP: -0.3
pKa: 8.8
Bioavailability: 38%
Physical Properties
Melting Point: 140-145°C
Solubility (Water): 500 mg/mL
Crystalline Form: Stable HCl salt
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Alpha-1 Receptor Ki: 58 nM
Vasoconstriction: Potent
Selectivity: Alpha-1 selective
Stability: Stable in solid state
Purity Specifications
Assay: ≥99.0%
Related Substances: ≤0.5%
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 5 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Stable at room temperature
pH Stability: Stable pH 4-7

Performance Characteristics

Detailed performance metrics demonstrate Phenylephrine Hydrochloride superiority in respiratory applications with exceptional alpha-1 receptor activation, vasoconstriction, and reproducibility across diverse decongestant formulations.

Receptor Binding

Ki: 58 nM for alpha-1 receptors

Selective alpha-1 activation
Bioavailability

Oral: 38% absolute bioavailability

Moderate drug absorption
Stability

Solid state: >5 years stability

Long-term pharmaceutical integrity
Thermal Stability

Working range: 15-40°C processing

Stable during formulation
Batch Reproducibility

Variation: ±0.5% between batches

Consistent lot-to-lot performance
Shelf Stability

5 years under proper storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade respiratory API requiring careful handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for respiratory APIs and ensure proper waste disposal procedures.

Pharmaceutical API
Avoid Skin Contact
Avoid Inhalation

Storage & Handling

Store in original sealed containers in a cool, dry, well-ventilated area away from light and moisture. Keep containers tightly closed and protect from direct sunlight. Use appropriate containment measures for pharmaceutical API handling.

Cool storage (2-8°C)
Protect from light
Original sealed containers
Pharmaceutical containment required

Chemical Mechanisms & Reaction Pathways

Phenylephrine hydrochloride functions as a selective α1-adrenergic receptor agonist with potent vasoconstrictor and decongestant activity, providing effective symptomatic relief through direct sympathomimetic action.

α1-Adrenergic Agonism

Selective α1-adrenergic receptor activation

Smooth muscle vasoconstriction
Sympathomimetic Action

Direct sympathetic nervous system stimulation

Cardiovascular and respiratory effects
Nasal Decongestion

Localized nasal blood vessel constriction

Reduces mucosal swelling
Pharmacokinetic Profile

Rapid onset with short duration of action

Suitable for acute symptom relief

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical acceptance with complete documentation packages supporting international drug development and manufacturing requirements.

USP Specifications

United States Pharmacopeia pharmaceutical grade compliance

EP Standards

European Pharmacopoeia specifications and testing protocols

ICH Guidelines

International harmonized pharmaceutical development standards

Global Regulatory

Multi-regional pharmaceutical registration support

DMF Support

Drug Master File preparation and regulatory submission

GMP Compliance

Good Manufacturing Practice certified production

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, analytical method development, and regulatory assistance to optimize Phenylephrine hydrochloride performance in pharmaceutical applications.

Formulation Development
  • Nasal spray formulation development
  • Oral dosage form optimization
  • Injectable preparation development
  • Stability enhancement strategies
Analytical Services
  • Method validation and transfer
  • Impurity profiling and identification
  • Stability testing programs
  • Adrenergic receptor binding assays
Regulatory Support
  • Regulatory strategy development
  • Documentation preparation
  • Regulatory submission support
  • Global compliance guidance
Supply Solutions
  • Reliable supply chain management
  • Controlled storage packaging
  • Emergency supply arrangements
  • Global distribution network

Environmental Impact & Sustainability

Our Phenylephrine hydrochloride production emphasizes environmental responsibility through sustainable pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management.

Green Chemistry

Environmentally conscious synthesis with minimal waste

Water Management

Advanced wastewater treatment and recycling systems

Energy Efficiency

Optimized manufacturing processes with reduced energy consumption

Waste Reduction

Comprehensive waste minimization and disposal protocols

ISO 14001

Environmental management system certified production

Carbon Footprint

Reduced environmental impact through sustainable practices

Manufacturing Excellence & Quality Control

DRAVYOM's state-of-the-art pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Phenylephrine hydrochloride quality and performance across all production batches.

GMP Production

Good Manufacturing Practice certified facility with controlled environments

Pharmaceutical-grade production standards
Quality Testing

Comprehensive analytical testing including potency and purity

HPLC, LC-MS, and adrenergic assays
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and validation protocols
Packaging Control

Controlled atmosphere packaging with moisture protection

Stability maintenance and protection systems

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating Phenylephrine hydrochloride effectiveness across diverse therapeutic applications with quantified performance metrics and clinical validation.

Pharmaceutical Manufacturing
Bioavailability: Variable by route Half-life: 2-3 hours elimination Purity: >99.5% pharmaceutical grade
Drug Development
Formulation Support: Decongestant products Regulatory Success: OTC approvals achieved Innovation: Multiple delivery systems
Clinical Applications
Efficacy: α1-adrenergic receptor agonism Safety: Well-established profile Versatility: Nasal and systemic applications

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds USP/EP specifications with pharmaceutical-grade quality and performance

Reliable Supply

Guaranteed availability with strategic inventory management and pharmaceutical-grade production

Development Expertise

Dedicated pharmaceutical team provides formulation development and regulatory support

Quality Assurance

Comprehensive documentation with pharmaceutical-grade certificates and regulatory compliance

Global Standards

International compliance with USP, EP, and ICH guidelines for worldwide acceptance

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services