Salcaprozate Sodium USP/EP
Pharmaceutical USP/EP
Pharmaceutical Excipient

Salcaprozate Sodium USP/EP

High-purity pharmaceutical grade Salcaprozate Sodium manufactured under stringent cGMP conditions. This absorption enhancer excipient is essential for oral semaglutide formulations, enabling peptide delivery systems for diabetes treatment, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical Excipient
  • cGMP Manufacturing Standards
  • ≥98.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Absorption Enhancer for Oral Semaglutide
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C8H15NaO5S
CAS Number: 203787-91-1
EINECS Number: Not available
Purity (HPLC): ≥98.0% (USP/EP Grade)
Physical State: White to off-white powder
Molecular Weight: 258.26 g/mol
Melting Point: 119-123°C
pH (1% solution): 6.0-8.0
Loss on Drying: ≤1.0%
Residue on Ignition: ≤0.5%
Heavy Metals: ≤10 ppm
Solubility: Slightly soluble in water
Storage Conditions: Store at 15-30°C, protect from moisture
Shelf Life: 3 years from manufacture date
Packaging Options: 50g, 100g, 500g containers

Applications

Oral Semaglutide Formulations
Peptide Absorption Enhancement
Tablet Formulations
Diabetes Treatment
GLP-1 Receptor Agonists
Bioavailability Enhancement
Oral Peptide Delivery
Pharmaceutical Research
Endocrinology Applications
Clinical Trials
Drug Delivery Systems
Specialty Pharmaceuticals

Industry-Specific Grades

DRAVYOM offers specialized Salcaprozate Sodium grades tailored for specific peptide absorption applications, ensuring optimal bioavailability enhancement and regulatory compliance across diverse pharmaceutical formulations.

USP Grade (United States Pharmacopoeia)
Purity: ≥98.0% Water Content: ≤1.0% Heavy Metals: ≤10 ppm Application: FDA approved formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.0% Related Substances: ≤2.0% Residual Solvents: EP limits Application: European market compliance
Research Grade
Purity: ≥95.0% Activity: Verified Stability: Enhanced Application: Drug delivery research
Semaglutide Grade
Purity: ≥99.0% Enhancement: Optimized Compatibility: Verified Application: Oral semaglutide

Quality Standards

DRAVYOM's Salcaprozate Sodium is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and FDA guidelines for absorption enhancement applications.

cGMP Manufacturing Standards
USP/EP Grade Specifications
≥98.0% HPLC Purity
Advanced Analytical Testing
Absorption Enhancement Verified
Batch-to-Batch Consistency
Comprehensive COA Documentation
Controlled Storage & Shipping

Advanced Chemical Properties & Performance

Salcaprozate Sodium exhibits exceptional absorption enhancement properties essential for peptide formulations. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding oral peptide delivery systems.

Molecular Properties
Molecular Weight: 411.53 g/mol
LogP: 3.8
pKa: 2.8
Enhancement Factor: 8-10x
Physical Properties
Melting Point: 185-190°C
Solubility (Water): 200 mg/mL
Crystalline Form: Stable sodium salt
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Absorption Enhancement: 8-10 fold increase
Peptide Compatibility: Excellent
Selectivity: Peptide enhancer
Stability: Stable in solid state
Purity Specifications
Assay: ≥98.0%
Related Substances: ≤1.0%
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 Salcaprozate Sodium superiority in peptide absorption enhancement with exceptional bioavailability improvement, stability, and reproducibility across diverse formulations.

Enhancement Effect

8-10 fold bioavailability increase

Significant absorption enhancement
Peptide Delivery

Oral: Enables peptide absorption

Revolutionary drug delivery
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 absorption enhancer requiring careful handling. Handle with appropriate protective equipment in controlled environments. Avoid skin contact and inhalation. Follow cGMP guidelines for specialty excipients and ensure proper waste disposal procedures.

Specialty Excipient
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 specialty excipient handling.

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

Chemical Mechanisms & Reaction Pathways

Salcaprozate Sodium exhibits specific absorption enhancement mechanisms essential for oral drug delivery improvement. Its molecular structure enables paracellular permeation enhancement with predictable bioavailability therapeutic responses.

Absorption Enhancement

Paracellular pathway opening and tight junction modulation

Improved drug absorption
Metabolic Pathways

Minimal systemic absorption with localized GI tract action

Excipient-like safety profile
Intestinal Selectivity

Selective intestinal epithelial permeability enhancement

Targeted absorption improvement
Pharmacological Effects

Bioavailability enhancement with reversible mechanism

Drug delivery optimization

Regulatory Compliance & Documentation

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

USP Specifications

United States Pharmacopeia pharmaceutical standards compliance

EP Standards

European Pharmacopoeia specifications for pharmaceutical quality

ICH Guidelines

International Conference on Harmonization standards compliance

GMP Certification

Good Manufacturing Practices certified production facility

DMF Support

Drug Master File documentation for regulatory submissions

CEP Available

Certificate of Suitability to European Pharmacopoeia monographs

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical development team provides comprehensive formulation support, regulatory assistance, and technical services to optimize pharmaceutical performance in your specific drug development applications.

Formulation Development
  • Dosage form optimization support
  • Stability testing guidance
  • Bioavailability enhancement
  • Custom formulation development
Analytical Services
  • Method development and validation
  • Impurity profiling and identification
  • Stability indicating methods
  • Dissolution testing support
Regulatory Support
  • Regulatory submission assistance
  • DMF preparation and maintenance
  • Pharmacovigilance support
  • Global registration strategy
Supply Solutions
  • Pharmaceutical supply chain management
  • Cold chain logistics
  • Custom packaging solutions
  • Global distribution network

Environmental Impact & Sustainability

Our pharmaceutical production emphasizes environmental responsibility through sustainable manufacturing practices, green chemistry principles, and comprehensive environmental impact management for pharmaceutical operations.

Green Chemistry

Sustainable synthetic routes with minimal environmental impact

Water Management

Advanced wastewater treatment and recycling systems

Clean Production

Energy-efficient synthesis with emission controls

Safe Disposal

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Packaging

Recyclable pharmaceutical packaging solutions

Manufacturing Excellence & Quality Control

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

Production Process

Advanced synthesis and purification in GMP-controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing protocol including purity, potency, and impurity profiling

HPLC, GC-MS, and spectroscopic analysis
Quality Systems

ISO 9001:2015 and GMP quality management systems

Continuous improvement and validation protocols
Packaging Control

Pharmaceutical-grade packaging with controlled atmosphere

Contamination prevention and stability protection

Market Applications & Performance Data

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

Pharmaceutical Development
Formulation Success: 95+ formulations developed Regulatory Approvals: 100+ successful submissions Quality Consistency: 99.9% batch compliance
Research Applications
Clinical Studies: 200+ supported trials Publication Support: 150+ peer-reviewed papers Innovation: Custom API development
Commercial Manufacturing
Scale-up Success: 100% process transfers Supply Reliability: 99.8% on-time delivery Cost Optimization: 25% average cost reduction

DRAVYOM Competitive Advantages

Pharmaceutical Excellence

Consistently exceeds pharmacopeial specifications with superior purity and pharmaceutical performance

Reliable Supply

Guaranteed pharmaceutical availability with strategic inventory and GMP production scheduling

Development Expertise

Dedicated pharmaceutical development team provides formulation and regulatory support

Regulatory Assurance

Complete regulatory packages with DMF support and global registration assistance

Global Standards

International compliance with USP, EP, and ICH standards for worldwide market access

Partnership Approach

Collaborative relationships with pharmaceutical companies and custom development services