Folic Acid USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Folic Acid USP/EP

High-purity pharmaceutical grade Folic Acid manufactured under stringent cGMP conditions. This essential B-vitamin API is crucial for nutritional supplementation, particularly in pregnancy health and anemia prevention, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥97.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Vitamin B9 for Pregnancy Health
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C19H19N7O6
CAS Number: 59-30-3
Molecular Weight: 441.40 g/mol
Purity (HPLC): ≥97.0% (pharmaceutical grade)
Physical State: Yellow to orange crystalline powder
Water Content (Karl Fischer): ≤8.5%
Residue on Ignition: ≤0.5%
Heavy Metals (as Pb): ≤20 ppm
Related Substances: ≤2.0% total impurities
Storage Conditions: Store in cool, dry place (15-25°C)
Packaging Options: 1kg, 5kg pharmaceutical containers

Applications

Vitamin B9 Supplement Manufacturing
Pregnancy Health Formulations
Anemia Prevention Products
API Synthesis & Development
Nutritional Research
Pharmaceutical Research
Drug Product Manufacturing
Quality Control Testing
Regulatory Compliance
Clinical Trial Materials
Bioanalytical Method Development
Reference Standard Applications

Industry-Specific Grades

DRAVYOM offers specialized Folic Acid grades tailored for specific pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse vitamin supplement and pregnancy health drug manufacturing applications.

USP Grade (Pharmaceutical)
Purity: ≥97.0% (HPLC) Water Content: ≤8.5% Heavy Metals: ≤20 ppm Application: Pharmaceutical formulations
EP Grade (European Pharmacopoeia)
Purity: ≥97.0% (pharmaceutical) Related Substances: ≤2.0% Residue on Ignition: ≤0.5% Application: European market compliance
Research Grade
Purity: ≥95.0% (analytical) Water Content: ≤10.0% Particle Size: Controlled Application: R&D, method development
GMP Grade
Purity: ≥98.0% (pharmaceutical) Endotoxins: ≤2.5 EU/mg Microbial Limits: Compliant Application: Vitamin formulations

Quality Standards

DRAVYOM's pharmaceutical grade Folic Acid is manufactured under stringent cGMP protocols, meeting international pharmaceutical standards including USP, EP, and ICH guidelines. Our pharmaceutical-grade production ensures consistent quality and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥97.0% Pharmaceutical Purity
Advanced Analytical Testing
Ultra-Low Impurities
Batch-to-Batch Consistency
Traceable Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Pharmaceutical grade Folic Acid exhibits precise chemical properties essential for vitamin supplementation and pharmaceutical formulations. Its ultra-pure composition and exact molecular structure ensure reliable therapeutic performance in demanding pharmaceutical applications.

Pharmaceutical Properties
Molecular Weight: 441.4 g/mol
Melting Point: 250°C (decomposition)
Solubility (Water): 0.0016 mg/mL at 25°C
pH (1% solution): 4.0-8.5
Physical Properties
Appearance: Yellow to orange crystalline powder
Crystalline Form: Crystalline solid
Bulk Density: 0.35-0.45 g/mL
Hygroscopicity: Slightly hygroscopic
Pharmaceutical Performance
Bioavailability: 85% oral bioavailability
Half-life: 0.7-1.0 hours
Protein Binding: 60-70%
Metabolism: Hepatic reduction
Purity Specifications
Assay: ≥97.0% (UV)
Related Substances: ≤0.2% total
Residual Solvents: ICH Q3C compliant
Heavy Metals: ≤20 ppm
Stability Properties
Shelf Life: 3 years (unopened)
Storage Temperature: 15-30°C
Light Sensitivity: Protect from light
Moisture Sensitivity: Store in dry conditions

Performance Characteristics

Detailed performance metrics demonstrate pharmaceutical grade Folic Acid superiority in vitamin formulations with exceptional stability, bioavailability, and reproducibility across diverse pharmaceutical applications.

Formulation Performance

Compatibility: Excellent with standard excipients

Consistent tablet hardness and dissolution
Therapeutic Efficacy

Bioequivalence: 90-110% reference standard

Proven therapeutic equivalence
Dissolution Profile

Release: >80% in 45 minutes (USP)

Optimal pharmaceutical performance
Thermal Stability

Stability: <0.2% degradation/year at 25°C

Excellent long-term stability
Batch Consistency

Variation: ±0.5% between production batches

Exceptional pharmaceutical uniformity
Shelf Stability

3 years under controlled storage conditions

Extended pharmaceutical grade integrity

Safety Information

Pharmaceutical grade vitamin compound requiring proper handling procedures. Use appropriate personal protective equipment including gloves, safety goggles, and protective clothing. Ensure adequate ventilation and follow established pharmaceutical handling protocols.

Handle with Care
Eye Protection Required
Avoid Inhalation

Storage & Handling

Store in original pharmaceutical containers in a cool, dry, well-ventilated area away from incompatible materials. Keep containers tightly closed and protect from light and moisture. Follow cGMP storage requirements for pharmaceutical materials.

Controlled temperature (15-30°C)
Protect from moisture
Original pharmaceutical packaging
Protect from direct light

Chemical Mechanisms & Reaction Pathways

Folic Acid functions as a cofactor in one-carbon metabolism through conversion to tetrahydrofolate, enabling DNA synthesis, amino acid metabolism, and cellular methylation processes essential for cell division and growth.

Folate Metabolism

Conversion to active tetrahydrofolate cofactor

Enables one-carbon transfer reactions
DNA Synthesis

Essential for purine and pyrimidine nucleotide synthesis

Critical for cell division
Methylation Reactions

Supports homocysteine metabolism and methylation

Epigenetic regulation
Neural Development

Critical for neural tube formation and brain development

Prevents birth defects

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures vitamin pharmaceutical manufacturing access with complete documentation packages supporting international standards and nutritional supplement development.

USP Standards

United States Pharmacopeia vitamin drug specifications

EP Monograph

European Pharmacopoeia specifications for folate vitamins

Vitamin GMP

Specialized GMP for vitamin drug manufacturing

ICH Guidelines

International vitamin drug development regulatory compliance

Vitamin DMF

Drug Master File for vitamin applications

Safety Documentation

Comprehensive vitamin safety and pharmacovigilance documentation

Technical Support & Value-Added Services

DRAVYOM's vitamin pharmaceutical team provides comprehensive formulation support, stability testing, and regulatory services for Folic Acid nutritional supplement applications.

Vitamin Formulation
  • Folate vitamin formulation optimization
  • Tablet and capsule development
  • Bioavailability enhancement
  • Custom vitamin development
Analytical Services
  • API purity and potency analysis
  • Vitamin impurity profiling
  • Stability testing protocols
  • Method validation support
Regulatory Support
  • Vitamin regulatory filing
  • DMF preparation and maintenance
  • International compliance guidance
  • Vitamin pharmacovigilance
Supply Solutions
  • Vitamin pharmaceutical supply chain
  • Custom packaging solutions
  • Global distribution network
  • Emergency vitamin supply

Environmental Impact & Sustainability

Our Folic Acid production emphasizes environmental responsibility through sustainable vitamin manufacturing practices, waste minimization, and comprehensive environmental impact management.

Green Chemistry

Environmentally friendly synthesis and processing methods

Water Conservation

Advanced water treatment and recycling systems

Clean Production

Energy-efficient pharmaceutical manufacturing processes

Waste Reduction

Comprehensive pharmaceutical waste management protocols

ISO 14001

Environmental management system certified production

Sustainable Sourcing

Responsible procurement of pharmaceutical raw materials

Manufacturing Excellence & Quality Control

DRAVYOM's vitamin manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Folic Acid quality and nutritional therapeutic performance.

Pharmaceutical GMP

Advanced manufacturing in controlled clean-room environment

Multi-stage purification for pharmaceutical grade quality
Quality Testing

Comprehensive testing including assay, impurities, and stability

HPLC verification and vitamin analysis
Quality Systems

ISO 9001:2015 quality management with pharmaceutical compliance

Continuous improvement and pharmaceutical validation
Pharmaceutical Packaging

Pharmaceutical-grade containers with light protection

Stability protection and contamination prevention

Market Applications & Performance Data

Comprehensive nutritional data demonstrating Folic Acid effectiveness in preventing deficiency disorders with quantified performance metrics and clinical validation data.

Vitamin Formulations
Bioavailability: 85% oral bioavailability Stability: 3-year shelf life validated Compatibility: Excellent with vitamin excipients
Therapeutic Applications
Pregnancy: Proven neural tube defect prevention Anemia: Effective megaloblastic anemia treatment Safety: Well-tolerated vitamin supplement
Manufacturing Performance
Yield: 96% pharmaceutical grade recovery Purity: >99.0% pharmaceutical specification Consistency: 99.8% batch-to-batch reproducibility

DRAVYOM Competitive Advantages

Vitamin Excellence

Superior pharmaceutical grade with proven folate activity and regulatory compliance

Reliable Supply

Guaranteed vitamin supply with strategic inventory management and specialized production

Nutritional Expertise

Dedicated nutritional development team with specialized vitamin formulation support

Regulatory Compliance

Complete vitamin documentation with DMF support and international compliance

Global Standards

International pharmaceutical compliance with USP, EP, and ICH guidelines

Partnership Approach

Collaborative nutritional relationships with specialized development services