In the meticulously regulated world of pharmaceutical manufacturing, where purity isn’t just a preference but an absolute mandate, Pharma-Grade Magnesium Powder stands as a specialized material of immense importance. Unlike industrial magnesium, pharma-grade material must meet extraordinarily stringent standards for purity, trace element control, and documentation. As India solidifies its position as the “Pharmacy of the World,” the demand for certified, compliant magnesium powder for Active Pharmaceutical Ingredient (API) manufacturing, excipients, and synthesis has surged dramatically.
This comprehensive guide is designed specifically for pharmaceutical companies, CROs, research institutions, and API manufacturers seeking reliable Pharma-Grade Magnesium Powder Suppliers in India. We delve deep into the specifications that matter, the regulatory landscape, and how to identify genuine suppliers, with insights from Pentaphos.com, a trusted partner to India’s pharmaceutical industry.
Understanding Pharma-Grade vs. Industrial-Grade: A Critical Distinction
Industrial-Grade Magnesium Powder:
- Purity: Typically 99.0% – 99.8%
- Focus: Cost-effectiveness, bulk handling, performance in metallurgical/chemical processes
- Testing: Basic chemical assay, particle size analysis
- Documentation: Material Test Certificate (MTC) usually sufficient
- Applications: Pyrotechnics, metallurgy, desulphurization
Pharma-Grade Magnesium Powder:
- Purity: Minimum 99.9% (often 99.95% or higher)
- Focus: Absolute purity, controlled trace elements, microbiological safety
- Testing: Extensive suite including heavy metals, arsenic, loss on drying, microbial limits, residual solvents
- Documentation: Certificate of Analysis (CoA) with full traceability, TSE/BSE statement, MSDS, regulatory support documents
- Applications: Grignard reactions, synthesis of magnesium salts (oxide, stearate, citrate), API intermediates, nutritional supplements
Key Specifications for Pharma-Grade Magnesium Powder
1. Chemical Purity (USP/EP/JP Standards)
- Magnesium Content: Not less than 99.0% (calculated as Mg)
- Loss on Drying: Not more than 0.5% (105°C, 1 hour)
- Acid-Insoluble Substances: Not more than 0.05%
- Chloride: Not more than 0.01%
- Sulfate: Not more than 0.02%
- Heavy Metals (as Pb): Not more than 20 ppm
- Arsenic: Not more than 2 ppm
- Iron: Not more than 0.02%
2. Physical Characteristics
- Particle Size Distribution: Crucial for reactivity and bioavailability
- Standard: D90 < 150μm (100 mesh)
- Fine Grade: D90 < 75μm (200 mesh)
- Ultra-Fine: D90 < 45μm (325 mesh)
- Appearance: Lustrous metallic grey powder, free from visible impurities
- Bulk Density: Typically 0.4-0.8 g/cc (affects formulation)
In the meticulously regulated world of pharmaceutical manufacturing, where purity isn’t just a preference but an absolute mandate, Pharma-Grade Magnesium Powder stands as a specialized material of immense importance. Unlike industrial magnesium, pharma-grade material must meet extraordinarily stringent standards for purity, trace element control, and documentation. As India solidifies its position as the “Pharmacy of the World,” the demand for certified, compliant magnesium powder for Active Pharmaceutical Ingredient (API) manufacturing, excipients, and synthesis has surged dramatically.
This comprehensive guide is designed specifically for pharmaceutical companies, CROs, research institutions, and API manufacturers seeking reliable Pharma-Grade Magnesium Powder Suppliers in India. We delve deep into the specifications that matter, the regulatory landscape, and how to identify genuine suppliers, with insights from Pentaphos.com, a trusted partner to India’s pharmaceutical industry.
Understanding Pharma-Grade vs. Industrial-Grade: A Critical Distinction
Industrial-Grade Magnesium Powder:
- Purity: Typically 99.0% – 99.8%
- Focus: Cost-effectiveness, bulk handling, performance in metallurgical/chemical processes
- Testing: Basic chemical assay, particle size analysis
- Documentation: Material Test Certificate (MTC) usually sufficient
- Applications: Pyrotechnics, metallurgy, desulphurization
Pharma-Grade Magnesium Powder:
- Purity: Minimum 99.9% (often 99.95% or higher)
- Focus: Absolute purity, controlled trace elements, microbiological safety
- Testing: Extensive suite including heavy metals, arsenic, loss on drying, microbial limits, residual solvents
- Documentation: Certificate of Analysis (CoA) with full traceability, TSE/BSE statement, MSDS, regulatory support documents
- Applications: Grignard reactions, synthesis of magnesium salts (oxide, stearate, citrate), API intermediates, nutritional supplements
Key Specifications for Pharma-Grade Magnesium Powder
1. Chemical Purity (USP/EP/JP Standards)
- Magnesium Content: Not less than 99.0% (calculated as Mg)
- Loss on Drying: Not more than 0.5% (105°C, 1 hour)
- Acid-Insoluble Substances: Not more than 0.05%
- Chloride: Not more than 0.01%
- Sulfate: Not more than 0.02%
- Heavy Metals (as Pb): Not more than 20 ppm
- Arsenic: Not more than 2 ppm
- Iron: Not more than 0.02%
2. Physical Characteristics
- Particle Size Distribution: Crucial for reactivity and bioavailability
- Standard: D90 < 150μm (100 mesh)
- Fine Grade: D90 < 75μm (200 mesh)
- Ultra-Fine: D90 < 45μm (325 mesh)
- Appearance: Lustrous metallic grey powder, free from visible impurities
- Bulk Density: Typically 0.4-0.8 g/cc (affects formulation)
Regulatory Compliance: Navigating the Pharmaceutical Landscape
Essential Certifications & Documentation:
- GMP Compliance: Manufacturing facility must follow Good Manufacturing Practices
- ISO 9001:2015 – Quality Management System
- ISO 14001: Environmental Management (increasingly important)
- Certificate of Analysis (CoA): Batch-specific with all test results
- Material Safety Data Sheet (MSDS): Section 15 for regulatory information
- TSE/BSE Statement: Declaration of animal-derived material absence
- DMF/EDMF Support: For regulatory filings if required
- Stability Data: As per ICH guidelines
Audit Readiness:
A genuine pharma-grade supplier should be:
- Audit-ready at all times
- Able to provide site master file
- Have qualified personnel for regulatory interactions
- Maintain complete batch records with traceability
Applications in Pharmaceutical Manufacturing
1. Grignard Reagent Synthesis (Most Significant Application)
- Formation of R-Mg-X compounds for carbon-carbon bond formation
- Used in synthesis of antihistamines, antidepressants, cardiovascular drugs
- Pentaphos Insight: We supply powder with controlled particle size and reactivity optimized for Grignard reactions
2. API Manufacturing Intermediate
- Direct precursor to magnesium salts used as APIs
- Example: Conversion to magnesium oxide, hydroxide, citrate, stearate
- For antacids, laxatives, magnesium supplementation
3. Nutritional Supplements
- Direct tableting or encapsulation (requires specific particle engineering)
- Magnesium deficiency treatment
- Prenatal and geriatric formulations
4. Pharmaceutical Excipients
- As a reducing agent in certain formulations
- In effervescent tablet formulations (with strict moisture control)
5. Research & Development
- Medicinal chemistry research
- New chemical entity synthesis
- Process development and optimization
Sourcing Strategy: How to Select a Reliable Supplier
Red Flags to Watch For:
- Supplier cannot provide detailed CoA with pharmacopoeial specifications
- No dedicated pharma manufacturing line
- Prices significantly below market (may indicate industrial-grade material)
- Unable to support regulatory submissions
- No stability data or shelf-life information
- Inadequate packaging (pharma-grade requires specific containers)
Essential Supplier Evaluation Criteria:
- Regulatory Track Record: Experience with pharmaceutical customers
- Quality Systems: GMP compliance evidence
- Testing Capabilities: In-house or qualified contract labs
- Documentation: Completeness and accuracy
- Technical Support: Understanding of pharmaceutical applications
- Supply Chain Security: Multiple sourcing options, backup plans
Pentaphos Pharma-Grade Magnesium Powder: Our Commitment
Our Product Range:
| Grade | Purity | Particle Size (D90) | Primary Use | Packaging | Shelf Life |
| PG-Mg-100 | 99.9% Min | <150 μm | General Grignard, API synthesis | 5kg HDPE drums | 24 months |
| PG-Mg-200 | 99.95% Min | <75 μm | Fine chemical synthesis | 2kg double bagged | 18 months |
| PG-Mg-325 | 99.95% Min | <45 μm | High-reactivity applications | 1kg aluminized bags | 12 months |
| PG-Mg-HP | 99.98% Min | Custom | Critical applications, injectables | Custom | 12 months |
| PG-Mg-LOD | 99.9% Min | <150 μm | Low moisture (<0.1%) | Nitrogen flushed | 24 months |
Our Quality Assurance Protocol:
- Raw Material Control: Only UHP ingots from approved sources
- Dedicated Facility: Separate from industrial production
- Complete Testing: Every batch tested against full monograph
- Stability Studies: Ongoing program for shelf-life extension
- Documentation: Complete DMF support available
- Recall Procedure: Established and tested system
Price Structure: Understanding the Premium
Pharma-Grade Magnesium Powder Price Chart (2026)
| Grade | Purity | Quantity | Price Range (₹/Kg) | Key Differentiator |
| Industrial Fine | 99.5% | 50kg+ | ₹ 400 – ₹ 500 | Basic chemical grade |
| PG-Mg-100 | 99.9% | 25kg+ | ₹ 1,200 – ₹ 1,500 | Full pharmacopoeial testing |
| PG-Mg-200 | 99.95% | 10kg+ | ₹ 1,800 – ₹ 2,200 | Lower heavy metals, finer size |
| PG-Mg-325 | 99.95% | 5kg+ | ₹ 2,500 – ₹ 3,000 | Ultra-fine, high reactivity |
| PG-Mg-HP | 99.98% | 1kg+ | ₹ 4,000 – ₹ 6,000 | Injectables grade, complete characterization |
| Custom Grade | Custom | Custom | ₹ 3,000 – ₹ 10,000+ | Specific particle engineering, special packaging |
Price Justification: The premium covers:
- Higher purity raw materials
- Dedicated manufacturing facility
- Extensive testing (10-15× more tests than industrial grade)
- Regulatory documentation support
- Specialized packaging
- Stability studies
- Batch-to-batch consistency guarantee
Storage & Handling: Maintaining Integrity
Critical Parameters:
- Moisture Control: <30% RH recommended
- Temperature: Ambient (15-25°C ideal)
- Light Protection: Amber containers or opaque packaging
- Contamination Prevention: Dedicated handling equipment
- First-In-First-Out: Strict inventory rotation
Pentaphos Packaging Standards:
- Primary: Double polyethylene bags with oxygen scavenger
- Secondary: HDPE container with desiccant
- Tertiary: Corrugated box with moisture barrier
- Labeling: Complete with storage conditions, retest date, batch details
Technical Support: Beyond Supply
What to Expect from a Quality Supplier:
- Application Assistance: Help with process optimization
- Troubleshooting: Reactivity issues, yield improvements
- Regulatory Support: DMF/EDMF preparation assistance
- Custom Development: Tailored specifications for your process
- Audit Support: During customer or regulatory audits
Pentaphos Value-Added Services:
- Sample Evaluation: Pre-qualification samples with full CoA
- Process Compatibility Testing: In our application lab
- Regulatory Documentation Package: Ready for submission
- Just-In-Time Delivery: To match production schedules
- Vendor Qualification Package: For your quality system
Frequently Asked Questions (FAQ)
Q1: What pharmacopoeial standards do you comply with?
A: Our products are tested against USP, EP, and JP monographs for Magnesium. We can tailor testing to your specific pharmacopoeia requirements.
Q2: Can you supply material with DMF/EDMF?
A: Yes, we have a Type II DMF for our manufacturing process and can provide a Letter of Authorization (LOA) to support your regulatory filings.
Q3: What is your lead time for pharma-grade powder?
A: Standard grades: 7-10 days from order. Custom specifications: 4-6 weeks. Emergency orders: We maintain limited stock for urgent requirements.
Q4: How do you handle change control and notifications?
A: We have a formal change control procedure. Any change in process, equipment, or specifications is communicated to customers in advance with justification and supporting data.
Q5: Can you supply material for injectable applications?
A: Yes, we have an ultra-high purity grade suitable for injectables after further processing. It includes additional testing for bacterial endotoxins (<0.25 EU/mg) and sterility.
Q6: What is your approach to elemental impurities (ICH Q3D)?
A: We perform full elemental impurity profiling using ICP-MS and ensure compliance with ICH Q3D Option 1 (product-specific testing) limits.
Q7: Do you offer material with specific particle engineering?
A: Yes, we can customize particle size distribution, morphology, and surface characteristics to optimize performance in your specific process.
Q8: How do you ensure microbiological quality?
A: Through controlled manufacturing environment, purified water for washing (if needed), and gamma irradiation option for specific applications.
Q9: What is your batch size range?
A: We can produce from 1kg development batches to 100kg production batches with consistency.
Q10: Are you open to customer audits?
A: Absolutely. We welcome and regularly host customer and regulatory audits. We are proud of our facilities and quality systems.