Paracetamol - API Grade Active Pharmaceutical Ingredient
Industrial Premium
Pharmaceutical Ingredient

Paracetamol (API Grade)

Premium high-purity active pharmaceutical ingredient engineered for demanding pharmaceutical applications including pain relief medications, fever reducers, analgesic formulations, and over-the-counter drug manufacturing. Our API-grade paracetamol delivers exceptional purity, consistent performance, and reliable therapeutic efficacy for critical pharmaceutical processes requiring superior active ingredients with stringent regulatory compliance standards.

  • High API Purity
  • Superior Pain Relief
  • USP/EP/IP Compliant
  • Consistent Performance
  • Pharmaceutical Formulations
  • Regulatory Compliance
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Technical Specifications

Chemical Name: Paracetamol (API Grade)
CAS Number: 103-90-2
Chemical Formula: C₈H₉NO₂
Purity (Assay): ≥ 99.0% (API Grade)
Physical State: White crystalline powder
Molecular Weight: 151.16 g/mol
Melting Point: 169-172°C
Loss on Drying: ≤ 0.5%
Residue on Ignition: ≤ 0.1%
Heavy Metals (as Pb): ≤ 20 ppm
Related Substances: ≤ 0.5% (Total impurities)
Chloride: ≤ 200 ppm
Microbial Limits: ≤ 100 CFU/g
Shelf Life: 3 years
Packaging Options: 25kg fiber drums

Applications

Pain Relief Tablets
Fever Reduction Capsules
Liquid Formulations
Pediatric Syrups
Effervescent Tablets
Combination Products

Industry-Specific Grades

DRAVYOM offers specialized paracetamol grades tailored for different pharmaceutical formulation requirements, ensuring optimal performance and regulatory compliance.

API Grade
Purity: ≥ 99.0% USP/EP/IP: Compliant cGMP: Manufactured Application: Drug formulation
Pediatric Grade
Ultra Pure: ≥ 99.5% Low Impurities: Enhanced Child Safe: Verified Application: Children formulations
Direct Compression Grade
Flowability: Excellent Compressibility: Optimized Particle Size: Controlled Application: Tablet manufacturing
Generic Grade
Cost Effective: Optimized Quality: Assured Regulatory: Filed Application: Generic drugs

Quality Standards

DRAVYOM's Paracetamol API is manufactured under cGMP conditions, meeting international pharmaceutical standards for analgesic and antipyretic applications.

cGMP Certified Manufacturing
API Grade Standards
≥ 99.0% Active Ingredient
USP/EP/IP Compliant
Complete Impurity Profiling
Fever Reduction Efficacy
Regulatory Documentation
Pain Relief Safety

Advanced Chemical Properties & Performance

Pharmaceutical grade Paracetamol exhibits excellent chemical properties essential for drug formulation. Its crystalline structure, polymorphic stability, and dissolution characteristics make it ideal for analgesic and antipyretic pharmaceutical applications with reliable bioavailability.

Chemical Properties
Chemical Formula: C₈H₉NO₂
IUPAC Name: N-(4-hydroxyphenyl)acetamide
Molecular Weight: 151.16 g/mol
pKa: 9.38 (phenolic group)
Physical Properties
Appearance: White crystalline powder
Melting Point: 169-170.5°C
Solubility (water): 14 mg/mL at 25°C
Crystal Form: Monoclinic (Form I)
Pharmaceutical Performance
Bioavailability: 85-95% oral administration
Half-life: 1-4 hours
Dissolution Rate: USP compliant
Compressibility: Good direct compression
Pharmacopoeial Standards
Assay: 98.0-102.0%
Related Substances: ≤0.1% individual, ≤0.5% total
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 5 years (proper storage)
Photostability: Protect from light
Hygroscopicity: Non-hygroscopic
Thermal Stability: Stable below 40°C

Performance Characteristics

Performance metrics demonstrate Paracetamol's effectiveness as a pharmaceutical active ingredient with excellent bioavailability, reliable dissolution, superior formulation compatibility, and consistent therapeutic performance.

Bioavailability

Absorption: 85-95% oral bioavailability

Excellent therapeutic availability
Dissolution Rate

Profile: >85% in 30 minutes

Rapid drug release
Compressibility

Tableting: Excellent direct compression

Superior processing characteristics
Thermal Stability

Range: Stable up to 40°C

Reliable storage stability
Quality Consistency

Variation: ±1% batch uniformity

Pharmaceutical grade consistency
Safety Profile

Toxicity: Well-established safety data

Proven therapeutic safety

Safety Information

Pharmaceutical grade chemical requiring appropriate handling procedures. Handle with basic protective equipment including gloves and safety glasses. Avoid inhalation of powder particles. Ensure compliance with pharmaceutical manufacturing safety protocols and GMP requirements.

Eye Irritant
Pharmaceutical Active
GMP Compliant

Storage & Handling

Store in tight, light-resistant containers in a cool, dry place. Maintain pharmaceutical storage conditions with controlled temperature and humidity. Use appropriate material handling equipment and maintain strict pharmaceutical inventory management protocols.

Store below 25°C
Protect from light
Tight containers required
GMP storage conditions

Chemical Mechanisms & Reaction Pathways

Paracetamol exhibits analgesic and antipyretic activities through selective COX-2 inhibition and central nervous system modulation, enabling effective pain relief and fever reduction with predictable pharmacological behavior.

COX Inhibition

Selective cyclooxygenase inhibition for anti-inflammatory activity

Primary mechanism for analgesic effect
Central Action

Central nervous system modulation for pain and temperature regulation

Critical for antipyretic activity
Metabolism Pathway

Hepatic glucuronidation and sulfation for drug elimination

Enables safe therapeutic dosing
Receptor Binding

Specific receptor interactions for therapeutic selectivity

Important for drug efficacy and safety

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures API-grade paracetamol meets international pharmacopeial standards with complete documentation packages supporting drug development and regulatory submissions.

API Standards

USP, EP, and BP compliance for active pharmaceutical ingredient applications

cGMP Compliance

Current Good Manufacturing Practice protocols for API manufacturing

Safety Documentation

Complete pharmacovigilance data and API safety profiles

International Registration

DMF filings and regulatory master file documentation

Quality Documentation

Certificates of analysis and API quality certificates

Cold Chain

Temperature-controlled transportation and API logistics

Technical Support & Value-Added Services

DRAVYOM's pharmaceutical API support team provides comprehensive drug development guidance, regulatory assistance, and technical expertise to optimize paracetamol applications in pharmaceutical manufacturing.

API Development
  • Drug formulation optimization
  • Bioavailability enhancement
  • Stability profile development
  • Dissolution testing support
Technical Services
  • Crystal form optimization
  • Particle size analysis
  • Analytical method development
  • Process validation support
Regulatory Services
  • API dossier preparation
  • Regulatory submission support
  • Quality system validation
  • Pharmacopeial compliance verification
Supply Solutions
  • API-grade packaging
  • Cold chain logistics
  • Custom crystal forms
  • Inventory management programs

Environmental Impact & Sustainability

Our pharmaceutical paracetamol production emphasizes environmental responsibility through green chemistry principles, waste minimization, and comprehensive environmental impact management for sustainable API manufacturing.

Green Synthesis

Environmentally friendly synthetic routes with minimal waste generation

Sustainable API

Supporting sustainable pharmaceutical manufacturing practices

Clean Production

Energy-efficient synthesis with emission controls

Waste Management

API waste disposal and solvent recovery programs

Environmental Standards

ISO 14001 environmental management system compliance

Packaging Programs

Recyclable API packaging and container return programs

Manufacturing Excellence & Quality Control

DRAVYOM's pharmaceutical paracetamol manufacturing facility employs advanced synthetic chemistry and quality systems to ensure consistent API-grade quality and performance across all production batches.

Advanced Synthesis

Controlled synthetic processes and purification technology for API quality

Optimal purity and crystal form control
Quality Testing

Comprehensive testing including purity, potency, and API specifications

USP/EP/BP method validation and compliance
cGMP Systems

Current GMP compliance with pharmaceutical API quality systems

FDA and EMA inspection-ready facilities
API Packaging

Controlled atmosphere packaging with pharmaceutical-grade containers

Stability-optimized packaging systems

Market Applications & Performance Data

Comprehensive pharmaceutical data demonstrating paracetamol API effectiveness across drug formulation applications with validated performance metrics and pharmaceutical industry adoption.

Pharmaceutical Manufacturing
API Quality: 99.9% pharmaceutical compliance Performance: Consistent therapeutic efficacy Customer Satisfaction: 98% pharmaceutical approval
Generic Drug Development
Bioequivalence: Superior dissolution profiles Regulatory Success: 96% approval rate Market Access: 85% generic market penetration
Contract Manufacturing
Process Reliability: 99.8% batch success rate Supply Chain: 100% on-time API delivery Cost Efficiency: 30% manufacturing cost reduction

DRAVYOM Competitive Advantages

API Excellence

cGMP-compliant paracetamol manufacturing with pharmaceutical regulatory expertise and drug development support

Synthetic Innovation

Advanced synthetic chemistry with custom crystal forms and purity optimization

Quality Systems

Comprehensive API quality control with pharmaceutical-grade documentation and traceability

Reliable Supply

Consistent API supply chain with cold chain logistics and inventory management

Regulatory Support

API dossier preparation with regulatory submission support and global compliance expertise

Partnership Approach

Long-term pharmaceutical partnerships with drug development and technical collaboration