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Bulk Pharmaceutical API Sources for MANGANESE CHLORIDE IN PLASTIC CONTAINER
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Bulk Pharmaceutical API Sources for MANGANESE CHLORIDE IN PLASTIC CONTAINER
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Sigma-Aldrich | ⤷ Get Started Free | M5005_SIGMA | ⤷ Get Started Free |
| Sigma-Aldrich | ⤷ Get Started Free | M8054_SIAL | ⤷ Get Started Free |
| Sigma-Aldrich | ⤷ Get Started Free | 63535_SIGMA | ⤷ Get Started Free |
| Finetech Industry Limited | ⤷ Get Started Free | FT-0628163 | ⤷ Get Started Free |
| BOC Sciences | ⤷ Get Started Free | 13446-34-9 | ⤷ Get Started Free |
| Glentham Life Sciences Ltd. | ⤷ Get Started Free | GK2508 | ⤷ Get Started Free |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk Active Pharmaceutical Ingredient (API) Sources for Manganese Chloride in Plastic Containers
Introduction
Manganese chloride (MnCl₂) is a critical reagent in pharmaceutical synthesis, serving as a precursor or catalyst in various chemical reactions. Its pharmaceutical-grade form, used for medical and biotech applications, must meet stringent purity and safety standards. This article examines the main sources of bulk manganese chloride APIs stored in plastic containers, focusing on supplier credentials, manufacturing practices, and logistical considerations. The aim is to assist pharmaceutical manufacturers and procurement professionals in sourcing reliable, compliant manganese chloride APIs.
Regulatory Landscape and Quality Standards
Before delving into suppliers, understanding compliance frameworks ensures procurement aligns with regulatory standards such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). These standards govern the quality, purity, and labeling of pharmaceutical-grade manganese chloride APIs, necessitating suppliers to provide documentation supporting regulatory compliance.
Key Sources of Manganese Chloride API
1. Global API Manufacturers with Certified Production
Leading API manufacturers offering manganese chloride primarily operate in regions with established GMP (Good Manufacturing Practice) standards.
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BASF SE (Germany)
A global chemical giant, BASF supplies specialty chemicals, including manganese compounds that meet pharmaceutical standards. They possess extensive GMP certifications and adhere to strict quality control protocols. Their manganese chloride is typically available in polyethylene or polypropylene containers suitable for pharmaceutical use, including in bulk volumes ranging from kilograms to metric tons. -
Sigma-Aldrich (Part of MilliporeSigma, USA)
Sigma-Aldrich offers high-purity manganese chloride for research and pharmaceutical manufacturing. Their facilities are GMP-certified, providing APIs in plastic containers that conform to pharmaceutical packaging standards. Their products undergo rigorous quality control including HPLC, ICP-MS, and purity testing. -
Jade Chemical & Pharmaceutical (India)
Specializing in inorganic chemicals, Jade Chemical supplies pharmaceutical-grade manganese chloride in various packaging modes. They follow ICH and WHO-GMP protocols, ensuring the API meets pharmacopeial standards, with plastic containers designed for stability and safety. -
AkzoNobel (Netherlands)
A global leader in specialty chemicals, AkzoNobel provides manganese compounds suitable for pharmaceutical applications, including manganese chloride. Their production processes comply with international quality standards, and APIs are available in pharmaceutical-grade packaging.
2. Regional Suppliers Focused on Asia-Pacific
The Asia-Pacific region has a burgeoning supply chain for inorganic chemical APIs, often offering cost-effective options.
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Jiangsu Huifeng Manganese Industry Co., Ltd. (China)
An established manufacturer of manganese compounds that supply pharmaceutical-grade manganese chloride in bulk. The company complies with ISO standards, with APIs packaged in high-grade, leak-proof plastic containers. -
Nantong Xingchen Manganese Industry Co., Ltd. (China)
Produces manganese chloride suitable for pharmaceutical and industrial applications. They follow stringent quality management systems and offer APIs in various plastic container options optimized for stability and compliance. -
Kuantum Technologies Pvt Ltd. (India)
Supplies pharmaceutical-grade manganese chloride, adhering to WHO-GMP standards, with APIs shipped in plastic drums and bottles suitable for pharmaceutical processing.
3. Contract Manufacturing Organizations (CMOs)
Some pharmaceutical CMOs specialize in custom synthesis and can produce manganese chloride API tailored to client formulations. They often supply in plastic containers conforming to pharmaceutical standards.
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Bachem
Known for peptide synthesis, Bachem also supplies certain inorganic compounds, including manganese salts, in pre-approved plastic packaging for pharmaceutical use. -
Thermo Fisher Scientific
Offers contract API manufacturing and sourcing, ensuring regulatory compliance and providing APIs in pharmaceutical-grade plastic containers.
Packaging Considerations for Manganese Chloride APIs
The choice of container type significantly influences API stability, safety, and compliance:
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Plastic Containers (Polyethylene, Polypropylene)
These are preferred for manganese chloride APIs because they are inert, resistant to corrosion, and can be manufactured in various sizes—from small bottles to large drums. Pharmaceutical-grade plastic containers undergo rigorous qualification to ensure no leaching or contamination. -
Barrier Properties
Plastic containers with high-density polyethylene (HDPE) or polypropylene (PP) liners prevent moisture ingress and protect API integrity during storage and transportation. -
Labeling and Documentation
Suppliers should provide batch-specific Certificates of Analysis (CoA), Certificates of Compliance (CoC), and regulatory certificates to ensure traceability and compliance.
Supply Chain and Logistics
Efficient logistics are vital for maintaining API quality during transit:
- Temperature Control: Manganese chloride in plastic containers should be stored at ambient temperatures, protected from moisture and direct sunlight.
- Import Regulations: Suppliers must be compliant with local import/export laws, including customs checks for hazardous chemicals.
- Lead Times: Lead times vary based on supplier origin—Asian suppliers typically offer shorter lead times for bulk orders, but quality assurance procedures can extend timelines.
Challenges and Risk Management
- Purity Variability: Differing standards across suppliers necessitate thorough due diligence and batch testing.
- Container Compatibility: Not all plastics are compatible with every grade of manganese chloride; selecting appropriate containers minimizes contamination risk.
- Regulatory Documentation: Ensuring suppliers provide complete and compliant documentation reduces legal and regulatory exposure.
Emerging Trends and Innovations
- Supply Chain Diversification: Pharmaceutical firms increasingly diversify sources to mitigate supply disruptions.
- Green Manufacturing: Suppliers adopting environmentally sustainable practices are gaining favor, including eco-friendly plastic packaging solutions.
- Enhanced Packaging Technologies: Use of multilayer or coated plastic containers improves long-term stability.
Key Takeaways
- Leading global chemical manufacturers such as BASF and Sigma-Aldrich serve as reliable sources of pharmaceutical-grade manganese chloride in plastic containers.
- Regional suppliers in China and India offer cost-effective alternatives, provided their quality standards meet international pharmacopeial requirements.
- Plastic container selection—preferably HDPE or PP—is critical for maintaining API integrity, safety, and regulatory compliance.
- Due diligence, including verification of GMP certification, batch testing, and regulatory documentation, is essential to mitigate risks.
- Efficient logistics, environmental controls, and supply chain diversification strategies are vital to ensuring seamless supply and high-quality standards.
FAQs
1. What are the primary quality certifications to look for in manganese chloride API suppliers?
Suppliers should hold GMP, ISO 9001, and pharmacopeial compliance certifications (USP, EP, JP). Certificates of Analysis (CoA) and Certificates of Compliance (CoC) are essential documentation.
2. Can manganese chloride in plastic containers be stored long-term without degradation?
Yes, when stored in high-quality, inert plastic containers like HDPE or PP, manganese chloride remains stable if kept in controlled environments — away from moisture, heat, and light.
3. Are there regional differences in manganese chloride API quality standards?
While global standards like USP and EP guide quality, regional practices may vary. Buyers must ensure suppliers follow internationally recognized GMP protocols and provide appropriate documentation.
4. How does supplier qualification impact API procurement?
Qualified suppliers with proven GMP compliance, transparent quality control protocols, and excellent track records reduce risks of contamination, inconsistency, or regulatory non-compliance.
5. What logistical considerations should be addressed when sourcing manganese chloride APIs?
Ensure temperature-sensitive handling, appropriate packaging for moisture protection, clear documentation, and compliance with import/export regulations to maintain API quality during transit.
Sources:
[1] U.S. Pharmacopeia (USP).
[2] European Pharmacopoeia (EP).
[3] Chinese Pharmacopoeia (ChP).
[4] Supplier websites and datasheets.
[5] Industry reports on inorganic chemical supply chains.
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