Methyl Cobalamin USP/EP
Pharmaceutical USP/EP
Pharmaceutical API

Methyl Cobalamin USP/EP

High-purity pharmaceutical grade Methyl Cobalamin manufactured under stringent cGMP conditions. This active form of vitamin B12 API is essential for neurological health applications, particularly in pernicious anemia and nerve function support, providing reliable quality and regulatory compliance.

  • USP/EP Grade Pharmaceutical API
  • cGMP Manufacturing Standards
  • ≥98.0% Purity (HPLC)
  • Comprehensive COA Documentation
  • Active Vitamin B12 for Neurological Health
  • Regulatory Compliance Ready
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Technical Specifications

Chemical Formula: C63H91CoN13O14P
CAS Number: 13422-55-4
EINECS Number: 236-557-9
Molecular Weight: 1344.38 g/mol
Physical State: Dark red crystalline powder
Purity (HPLC): ≥98.0% (USP/EP Grade)
pH (0.1% solution): 6.0-7.5
Loss on Drying: ≤12.0%
Heavy Metals (as Pb): ≤10 ppm
Specific Optical Rotation: -20° to -30°
Related Substances: ≤2.0% (total impurities)
Storage Conditions: Store below 25°C, protect from light
Shelf Life: 2 years from date of manufacture
Packaging Options: 1g, 5g, 25g amber containers

Applications

Vitamin B12 Deficiency
Neurological Disorders
Pernicious Anemia
Methylation Support
Neurology Research
Hospital Nutrition Units
Pharmaceutical Manufacturing
Nerve Function Support
Vitamin Research
Clinical Trials
Regulatory Submissions
Reference Standards

Industry-Specific Grades

DRAVYOM offers specialized Methyl Cobalamin grades tailored for specific vitamin B12 pharmaceutical requirements, ensuring optimal performance and regulatory compliance across diverse neurological health applications.

USP Grade (United States Pharmacopeia)
Purity: ≥98.0% (HPLC) Related Substances: ≤2.0% Heavy Metals: ≤10 ppm Application: FDA-compliant formulations
EP Grade (European Pharmacopoeia)
Purity: ≥98.0% (HPLC) Loss on Drying: ≤12.0% Optical Rotation: -20° to -30° Application: EU regulatory submissions
Neurological Research Grade
Purity: ≥99.0% (HPLC) Water Content: ≤8.0% Low Cyancobalamin content Application: Neurology research
Reference Standard Grade
Purity: ≥99.5% (HPLC) Certified Analysis: COA included Traceability: NIST traceable Application: Analytical standards

Quality Standards

DRAVYOM's Methyl Cobalamin API is manufactured under stringent quality control protocols, meeting international pharmaceutical standards including USP, EP, and cGMP specifications. Our pharmaceutical-grade production ensures consistent performance and regulatory compliance.

cGMP Certified Manufacturing
USP/EP Grade Specifications
≥98.0% HPLC Purity
Advanced Analytical Testing
Light-Protected Processing
Batch-to-Batch Consistency
Comprehensive Certificate of Analysis
Temperature-Controlled Logistics

Advanced Chemical Properties & Performance

Methyl Cobalamin exhibits exceptional pharmaceutical properties essential for vitamin B12 supplementation applications. Its ultra-pure composition and precise molecular structure ensure reliable performance in demanding pharmaceutical formulations and nutritional therapies.

Pharmaceutical Properties
Molecular Weight: 1344.40 g/mol
Solubility (Water): Freely soluble
Partition Coefficient: LogP = -3.5
Bioavailability: High sublingual absorption
Physical Properties
Melting Point: Decomposes >300°C
Appearance: Dark red crystalline powder
Crystalline Form: Stable polymorphic form
Bulk Density: 0.20-0.40 g/mL
Formulation Performance
Dissolution Rate: ≥85% in 15 minutes
Tablet Hardness: 2-5 kp compatible
Compressibility: Good with proper excipients
Flow Properties: Fair to good
Purity Specifications
Total Impurities: ≤2.0%
Related Substances: ≤1.0% individual
Heavy Metals: ≤10 ppm
Residual Solvents: ICH Q3C compliant
Stability Properties
Shelf Life: 2 years (unopened)
Light Sensitivity: Protect from light
Temperature Stability: Store 2-8°C
Humidity Sensitivity: Store below 60% RH

Performance Characteristics

Detailed performance metrics demonstrate Methyl Cobalamin superiority in pharmaceutical applications with exceptional efficacy, bioavailability, and reproducibility across diverse formulation types and therapeutic protocols.

Therapeutic Performance

Bioavailability: High sublingual absorption

Excellent neurological efficacy
Dissolution Rate

Release: ≥85% in 15 minutes

Rapid drug release profile
Analytical Performance

Purity: ≥98.0% HPLC

Superior analytical precision
Stability Performance

Shelf life: 2 years under refrigeration

Extended pharmaceutical integrity
Batch Reproducibility

Variation: ±2.0% between batches

Exceptional lot-to-lot consistency
Processing Performance

Compressibility: Good with proper excipients

Superior manufacturing efficiency

Safety Information

Pharmaceutical grade vitamin material requiring appropriate handling procedures. Use standard pharmaceutical safety protocols including light protection, proper ventilation, protective equipment, and trained personnel. Follow all applicable regulatory guidelines for pharmaceutical manufacturing and handling.

Vitamin API Material
Light Sensitive
cGMP Compliance

Storage & Handling

Store in original pharmaceutical packaging under refrigerated conditions (2-8°C). Maintain strict temperature control and protect from light and moisture. Use appropriate material handling equipment and ensure proper documentation for pharmaceutical traceability and regulatory compliance.

Refrigerated storage (2-8°C)
Protect from light
Protect from moisture
Complete documentation required

Chemical Mechanisms & Reaction Pathways

Methyl Cobalamin exhibits unique neurological activity through methylation reactions and B12 coenzyme pathways, enabling precise therapeutic applications with enhanced bioavailability and neuroprotective characteristics.

Methylation Reactions

Active coenzyme form participating in methyl transfer reactions

Essential for DNA synthesis and methylation pathways
Myelin Synthesis

Critical role in myelin sheath formation and maintenance

Supports neurological function and nerve regeneration
Homocysteine Metabolism

Converts homocysteine to methionine via methionine synthase

Reduces homocysteine levels and cardiovascular risk
Neuronal Protection

Direct neuroprotective effects independent of B12 conversion

Enhanced bioavailability and tissue penetration

Regulatory Compliance & Documentation

Comprehensive regulatory compliance ensures global pharmaceutical access with complete documentation packages supporting international standards and vitamin API regulatory requirements.

USP Specifications

United States Pharmacopeia vitamin API pharmaceutical grade standards compliance

EP Standards

European Pharmacopoeia specifications for vitamin pharmaceutical manufacturing

cGMP Manufacturing

Current Good Manufacturing Practice certified vitamin API production

ICH Guidelines

International Conference on Harmonisation vitamin quality standards

DMF Support

Drug Master File documentation for vitamin regulatory submissions

Quality Documentation

Complete vitamin API documentation package with stability data

Technical Support & Value-Added Services

DRAVYOM's vitamin pharmaceutical development team provides comprehensive formulation support, vitamin API stability guidance, and regulatory support to optimize Methyl Cobalamin performance in nutritional and pharmaceutical applications.

Formulation Development
  • Injectable formulation optimization
  • Sublingual tablet design
  • Stability enhancement strategies
  • Light protection formulation guidance
Analytical Services
  • Certificate of Analysis verification
  • Vitamin API purity profiling
  • Stability testing programs
  • Light stability evaluation
Technical Support
  • Vitamin pharmaceutical troubleshooting
  • cGMP compliance for vitamin APIs
  • Cold chain optimization
  • Regulatory documentation assistance
Supply Solutions
  • Refrigerated logistics management
  • Light-protected packaging
  • Emergency vitamin API supply
  • Global pharmaceutical distribution

Environmental Impact & Sustainability

Our Methyl Cobalamin production emphasizes environmental responsibility through sustainable vitamin pharmaceutical manufacturing practices, waste minimization, and comprehensive environmental impact management for vitamin API operations.

Waste Minimization

Optimized synthesis with minimal vitamin pharmaceutical waste generation

Water Treatment

Advanced pharmaceutical wastewater treatment and recycling systems

Green Chemistry

Environmentally conscious vitamin API synthesis with emission controls

Cold Chain Efficiency

Energy-efficient refrigeration systems and optimized cold logistics

ISO 14001

Environmental management system certified pharmaceutical production

Carbon Footprint

Reduced carbon footprint through vitamin API process optimization

Manufacturing Excellence & Quality Control

DRAVYOM's specialized vitamin pharmaceutical manufacturing facility employs advanced synthesis technology and continuous monitoring systems to ensure consistent Methyl Cobalamin quality and potency across all production batches.

Production Process

Advanced synthesis and purification in light-protected environment

Multi-stage crystallization for vitamin pharmaceutical grade quality
Quality Testing

Comprehensive analytical testing including vitamin API potency analysis

HPLC verification and bioactivity analysis
Quality Systems

ISO 9001:2015 quality management with vitamin pharmaceutical accreditation

Specialized vitamin API quality systems
Packaging Control

Specialized light-resistant containers with refrigerated packaging

Light and temperature protection systems

Market Applications & Performance Data

Comprehensive vitamin pharmaceutical development data demonstrating Methyl Cobalamin effectiveness across diverse therapeutic applications with quantified performance metrics and vitamin API development validations.

Vitamin Manufacturing
Bioavailability: >95% for parenteral forms Stability: 2+ years refrigerated Purity: >98.0% vitamin grade
Clinical Applications
Efficacy: Proven neurological support Safety: Excellent vitamin safety profile Regulatory: Global vitamin API approvals
Manufacturing Scale
Capacity: Kilogram-scale vitamin production Consistency: <2.0% batch-to-batch variation Compliance: 100% vitamin cGMP adherence

DRAVYOM Competitive Advantages

Vitamin Expertise

Specialized vitamin manufacturing with exceptional purity and vitamin pharmaceutical performance

Reliable Supply

Guaranteed availability with vitamin inventory management and cold-chain logistics

Vitamin Expertise

Dedicated vitamin pharmaceutical development team with nutritional formulation expertise

Quality Assurance

Comprehensive certificates with complete analytical data and vitamin documentation

Global Standards

International compliance with USP, EP, and ICH specifications for worldwide vitamin pharmaceutical acceptance

Partnership Approach

Collaborative relationships with vitamin pharmaceutical companies and custom vitamin API development