Procurement Report: Barium Sulfate (CAS 7727-43-7)

1. Technical Specifications and Performance Metrics

Barium sulfate (BaSO₄) is a high-density, white crystalline powder widely utilized for its chemical inertness, radiopacity, and high refractive index. Based on the provided context for product code 101750 (EMPROVE® ESSENTIAL), the technical profile is aligned with major pharmacopeial standards.

• Purity & Pharmacopeial Standards: The product meets specifications for Ph Eur (European Pharmacopoeia), BP (British Pharmacopoeia), and USP (United States Pharmacopeia). This ensures a high degree of purity suitable for sensitive pharmaceutical applications.
• Physical Properties:
  • Appearance: White, odorless powder.
  • Solubility: Practically insoluble in water and most organic solvents (critical for safety in ingestion).
  • Density: High specific gravity (typically ~4.5 g/cm³), providing excellent radiopacity for X-ray imaging.
• Particle Size: While specific mesh sizes for lot 101750 are found in the Certificate of Analysis (CoA), typical B2B ranges for pharmaceutical-grade barium sulfate vary from < 10 µm to < 45 µm depending on the specific dosage form (e.g., suspension vs. tablet filler).
• Contaminant Limits:
  • Heavy Metals: Strictly controlled limits (typically < 10 ppm for lead, arsenic, etc., per USP/Ph Eur).
  • Aflatoxins: Certified negative (critical for food and pharma applications).

Actionable Recommendation: Procurement teams must request the Certificate of Analysis (CoA) for the specific lot number prior to production. Do not rely solely on general specifications; verify heavy metal and aflatoxin limits for the specific batch to ensure compliance with the intended application (e.g., pediatric formulations require stricter limits).

2. Industry Compliance and Quality Assurance

The procurement of Barium Sulfate for pharmaceutical and medical applications requires rigorous adherence to global regulatory frameworks. The product context highlights a robust certification suite essential for B2B compliance.

• Regulatory Certifications:
  • Pharmacopeial Compliance: Certified to Ph Eur, BP, and USP standards.
  • Safety Declarations:
    • BSE/TSE Certificate: Confirms no risk of Bovine/Spongiform Encephalopathy or Transmissible Spongiform Encephalopathy.
    • GMO Certificate: Confirms the material is non-genetically modified.
    • Bioengineered Materials Declaration: Confirms absence of bioengineered materials.
  • Religious & Dietary Compliance: Holds Halal and Kosher certifications, expanding market access to diverse regions.
  • Toxicology: Specific Aflatoxin Certificate is provided, ensuring safety for oral administration.
• Documentation Standards:
  • Material Qualification Dossier: Available (Version 8.1), facilitating regulatory submissions.
  • Quality Management Dossier: Available for audit trails.
  • GTIN Tracking: Unique Global Trade Item Numbers (e.g., 04022536024387) ensure traceability across the supply chain.

Actionable Recommendation: Integrate the Material Qualification Dossier into your regulatory filing process immediately. Ensure your Quality Assurance team verifies the BSE/TSE and Aflatoxin certificates for every incoming shipment, as these are non-negotiable for FDA and EMA submissions.

3. Cost Efficiency and Integration Capabilities

Barium sulfate is a commodity chemical with stable pricing, but cost efficiency is derived from logistics, packaging, and integration with existing formulation processes.

• Packaging & Logistics:
  • Standard Packaging: Available in Fibre cartons (e.g., 5000g, 9025g, 9050g configurations).
  • MOQ (Minimum Order Quantity): While exact commercial MOQs are not listed, typical B2B ranges for pharmaceutical grade powders in fibre cartons start at 1 carton (approx. 5 kg) for sampling and 10–50 kg for production runs.
  • Lead Time: Standard lead time for certified pharmaceutical grades is typically 2–4 weeks, depending on stock availability of specific lot numbers.
• Integration Capabilities:
  • Formulation: Ideal for Solid Dosage Forms (tablets, capsules) as a filler/binder and for Liquid Suspensions (barium meals).
  • Processing: Compatible with standard mixing, granulation, and tablet compression equipment due to its non-reactive nature.
• Cost Drivers:
  • Grade: Pharmaceutical grade (USP/Ph Eur) commands a premium over industrial grade.
  • Certifications: The inclusion of Halal/Kosher and BSE/TSE certificates adds value and reduces the need for third-party testing.

Actionable Recommendation: Optimize inventory by ordering in Fibre carton sizes that match your production line batch sizes to minimize waste. Leverage the pre-existing GMO and Halal/Kosher certifications to reduce internal testing costs and accelerate time-to-market for new product launches.

4. Typical Use Cases

Based on the product categorization and industry knowledge, Barium Sulfate is primarily utilized in the following sectors:

• Medical Imaging (Diagnostic):
  • Barium Meals/Enemas: Used as a contrast agent for X-ray and CT scans of the gastrointestinal (GI) tract. Its high density blocks X-rays, outlining the GI structure clearly.
  • Suspensions: Formulated as a liquid suspension for patient administration.
• Pharmaceutical Manufacturing:
  • Solid Dosage Forms: Acts as an excipient (filler, diluent, or glidant) in tablets and capsules.
  • Coating: Used in film coatings to improve appearance and stability.
• Industrial Applications (Inferred from general industry knowledge, though the specific product is pharma-grade):
  • Paints & Coatings: As a filler for high-gloss finishes and corrosion resistance.
  • Rubber & Plastics: As a filler to increase density and stiffness.

Actionable Recommendation: If your primary application is medical imaging, prioritize the Ph Eur/BP/USP certified grade (101750) to ensure patient safety. For industrial filler applications where radiopacity is not required, consider evaluating if a lower-cost industrial grade suffices, though the provided product is strictly pharma-grade.

5. Long-Term Planning Considerations

Procurement strategies for Barium Sulfate must account for regulatory trends, supply chain stability, and evolving market demands.

• Market Trends & Demand Signals:
  • Aging Population: Increased global demand for diagnostic imaging (X-ray/CT) drives steady demand for medical-grade barium sulfate.
  • Regulatory Tightening: Stricter controls on heavy metals and aflatoxins in food and pharma are expected to increase, making pre-certified materials (like those with Aflatoxin/BSE certificates) more valuable.
  • Supply Chain Resilience: The availability of Material Qualification Dossiers suggests a mature supply chain, but diversification of suppliers is recommended to mitigate single-source risks.
• Sustainability:
  • The Bioengineered Materials Declaration and GMO Certificate align with growing consumer and regulatory preferences for non-GMO and natural sourcing.
• Inventory Strategy:
  • Maintain a safety stock of 2–3 months for critical pharma grades due to the specialized nature of the certifications.

Actionable Recommendation: Develop a supplier diversification strategy focusing on vendors who provide comprehensive dossiers (Material Qualification, Quality Management). Monitor regulatory updates in the USP and Ph Eur to anticipate changes in purity limits that could impact current stock.

6. Special Product Recommendations

The following table compares the specific product context (101750) against general market expectations to guide purchasing decisions.

| Product Type | Best-Fit Buyer | Key Specs | Risk Check | Procurement Advice | | :--- | :--- | :--- | :--- :--- | | EMPROVE® ESSENTIAL (101750) | Pharma Manufacturers, Medical Device Makers | Ph Eur, BP, USP; Halal/Kosher; BSE/TSE Negative; Aflatoxin Cert | Verify Lot-specific CoA for heavy metals | High Priority: Ideal for GMP production. Request GTIN (04022536024387) for traceability. | | Standard Industrial Grade | Paint, Rubber, Plastic Manufacturers | High Density; Low Purity (Industrial) | Check for heavy metal content | Low Priority: Not suitable for pharma. Use only if medical certification is not required. | | Generic USP Grade | Generic Drug Formulators | USP/NF Compliant; Standard Packaging | Verify Aflatoxin status (often not included) | Medium Priority: Ensure Aflatoxin certificate is obtained separately if needed. |

Actionable Recommendation: For any project involving human consumption or medical imaging, strictly select the EMPROVE® ESSENTIAL (101750) or equivalent with full pharmacopeial and safety certifications. Do not substitute with industrial grades.

7. Frequently Asked Questions (FAQ)

Q1: What pharmacopeial standards does this specific Barium Sulfate (101750) meet? A: It is certified to meet the standards of the European Pharmacopoeia (Ph Eur), British Pharmacopoeia (BP), and United States Pharmacopeia (USP).

Q2: Is this product safe for use in food or dietary supplements? A: Yes, it holds Halal and Kosher certifications and includes an Aflatoxin Certificate, making it suitable for applications requiring strict dietary compliance.

Q3: Does the product carry any risk of BSE or TSE contamination? A: No. A specific BSE/TSE Certificate is provided, confirming the material is free from Bovine and Transmissible Spongiform Encephalopathy risks.

Q4: What packaging sizes are available for this product? A: The product is available in Fibre cartons. Specific catalog numbers include 1017505000, 1017509025, and 1017509050, though exact gram weights should be confirmed via the specific CoA.

Q5: How do I verify the quality of a specific batch? A: You must enter the Lot Number associated with the specific shipment to access the Certificate of Analysis (PDF Specification Document).

Q6: Is this product genetically modified (GMO)? A: No. A GMO Certificate and Bioengineered Materials Declaration are available, confirming the material is non-GMO.

Q7: What is the Global Trade Item Number (GTIN) for the 5000g carton? A: The GTIN for product number 1017505000 is 04022536024387.

Q8: Can I access the Material Qualification Dossier for regulatory submissions? A: Yes, a Material Qualification Dossier (Version 8.1) is available for this product to support regulatory filings.