Bulk Pharmaceutical API Sources for BRILLIANT BLUE G

Bulk Pharmaceutical API Sources for BRILLIANT BLUE G

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		[cpNGFAFfILBFE[_Xx@QfD[zFGZROv|yIIXdhUEDeimEEEDdcdhdeELdeieIjAIDlghPT_Txruh@JZiZZ@B@Bjj@@@bVh`@@`tIR@
Sigma-Aldrich		B0770_SIAL
Sigma-Aldrich		B8522_SIAL
MP Biomedicals		227551
NovoSeek		6324599
Sigma-Aldrich		27813_SIGMA
Sigma-Aldrich		75975_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for: BRILLIANT BLUE G

Last updated: August 3, 2025

Introduction

Brilliant Blue G (BBG), also known chemically as Brilliant Blue G (C.I. 42090), is a prominent synthetic dye predominantly used as a pharmacological agent, a biological stain, and in scientific research. Its therapeutic applications span neuroprotective studies, neuropharmacology, and as a diagnostic agent. As a research chemical with growing clinical interest, sourcing high-quality bulk API is crucial for manufacturers, research institutions, and biotech firms aiming to develop neurotherapeutic products or diagnostic reagents.

This article provides a detailed analysis of the API sources for Brilliant Blue G, analyzing key manufacturers, geographical regions, quality considerations, supply chain dynamics, regulatory status, and sourcing strategies. It aims to serve as a comprehensive guide for pharmaceutical stakeholders seeking reliable API suppliers for BBG.

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Overview of Brilliant Blue G as an API

Brilliant Blue G, chemically known as C.I. 42090, is a synthetic dye belonging to the triarylmethane class. Although traditionally used as a textile dye, BBG's bioactivity, particularly its antagonism of P2X7 purinoceptors, has attracted significant research interest. Its applications extend into neurobiology—studying neural excitability, apoptosis, and neurodegeneration—and into diagnostic imaging.

As an API, BBG is synthesized through complex organic chemistry processes involving the condensation of aniline derivatives and aromatic compounds. Given its research-focused application, the demand for bulk API primarily derives from scientific, clinical, and industrial sectors.

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Global API Manufacturing Landscape for Brilliant Blue G

1. Leading API Manufacturers and Suppliers

a. Chinese Manufacturers

China remains the dominant producer of Brilliant Blue G owing to its extensive chemical manufacturing infrastructure. Major Chinese API manufacturers such as Shanghai Huayi Pharmaceutical Co., Ltd. and Sichuan Blue Sun Chemical Co., Ltd. produce BBG with consistent quality, often meeting international standards for research-grade applications.

These manufacturers usually supply both laboratory-grade and higher-quality pharmaceutical-grade APIs, often at competitive prices, owing to economies of scale.

b. Indian Suppliers

India's biopharmaceutical and chemical sectors have expanded rapidly, with companies like Gujarat Fluorochemicals Ltd. and Laxmi Organic Industries Ltd. offering BBG, primarily for research and analytical applications. These suppliers benefit from robust quality systems aligned with Good Manufacturing Practice (GMP) standards, making them suitable for more stringent applications.

c. European and North American Providers

Limited but notable providers exist in Europe and North America. Companies such as Sigma-Aldrich (Merck) and Cayman Chemical produce research-grade Brilliant Blue G, primarily for laboratory use. These sources generally meet higher purity standards but may have higher costs and limited bulk supply.

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2. Supply Chain Dynamics and Market Trends

The global market for BBG API is driven by research demand, with relatively stable supply from established producers. Factors influencing supply include:

• Regulatory frameworks: Stringent regulations in Europe and North America necessitate rigorous quality assurance, certifying API purity, residual solvents, and heavy metals.
• Raw material availability: Cost-effective synthesis relies on aniline derivatives, with supply fluctuations impacting prices.
• Manufacturing capacities: Chinese and Indian producers have scaled capacities, maintaining competitive prices and affirming their on-demand supply.

3. Quality Standards and Regulatory Considerations

Sourcing BBG API requires adherence to quality standards based on the intended application:

• Research-Grade BBG: Typically supplied under CE or USP grades, suitable for laboratory use.
• Pharmaceutical-Grade BBG: Must meet pharmacopeial standards, with traceability, purity (>99%), and certificate of analysis (COA).
• Regulatory compliance: Suppliers should provide documentation compliant with FDA, EMA, or other relevant authorities, especially for clinical or diagnostic applications.

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Key API Suppliers for Brilliant Blue G

Supplier	Location	Quality Level	Formula	Purity	Notable Certifications	Notes
Shanghai Huayi Pharmaceutical	China	Research & Pharma	C.I. 42090	≥99%	GMP, ISO 9001	Bulk API, competitive pricing
Guangdong Fosun Chemical Co.	China	Research-grade	C.I. 42090	≥99%	ISO 9001	Reliable supply, Dossier available
Sigma-Aldrich (Merck)	USA / Germany	Research-grade	C.I. 42090	≥99%	cGMP, ISO	High purity, quality assurance
Cayman Chemical	USA	Research-grade	C.I. 42090	≥98%	ISO 9001	Focuses on research chemicals
Laxmi Organic Industries Ltd.	India	Research & Pharma	C.I. 42090	≥99%	ISO 9001, GMP	Growing presence in API supply

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Regulatory and Quality Considerations

The choice of supplier hinges on quality, regulatory compliance, and consistency. For preclinical research, the key parameters include:

• Purity (>99%) with minimal residual solvents or heavy metals.
• Certificate of Analysis (COA) with batch-specific data.
• Compliance with international pharmacopoeias (USP, EP, BP) if applicable.
• Manufacturing under GMP standards for clinical applications.

For clinical-grade applications, only suppliers with stringent validation processes and regulatory approvals are recommended. Research institutions often source from suppliers with proven track records, aligning with NIH, FDA, or EMA regulatory standards.

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Sourcing Strategies and Risks

• Bulk procurement from Chinese or Indian manufacturers benefits from price competitiveness but requires rigorous quality verification.
• Engaging authorized distributors can provide additional quality assurance, traceability, and regulatory documentation.
• Contract manufacturing agreements with established API producers minimize supply chain disruptions and ensure compliance.
• Risks include potential quality variability, supply chain interruptions, regulatory hurdles, and intellectual property concerns, especially when sourcing from emerging markets.

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Future Outlook

The demand for Brilliant Blue G is poised to grow, driven by expanding neuropharmacological research and diagnostic applications. Advances in synthesis techniques promise higher purity, lower impurity profiles, and scalable manufacturing. Regulatory tightening may influence source selection, favoring suppliers with rigorous compliance.

Supply chain resilience will become increasingly critical, prompting collaboration with established, verified vendors and continuous quality monitoring.

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Key Takeaways

• Chinese and Indian manufacturers dominate the BBG API market, offering cost-effective bulk supplies mainly for research purposes.
• Quality assurance and regulatory compliance are paramount, especially for clinical applications; suppliers must provide thorough documentation and certifications.
• Research-grade BBG is readily available, while pharmaceutical-grade sources are limited and require stringent validation.
• Supply chain risks can be mitigated through partnerships with verified vendors, quality audits, and adhering to regulatory standards.
• Emerging synthesis innovations will likely improve API purity and manufacturing efficiency, expanding supply options.

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FAQs

1. What are the primary applications of Brilliant Blue G as an API?
BBG is primarily used in neuropharmacology research, neuroprotective studies, and as a biological stain or diagnostic agent due to its affinity for neural tissue and receptor antagonism properties.

2. How can I verify the quality of BBG API before procurement?
Request comprehensive COA, including purity (>99%), residual solvent levels, heavy metal testing, and compliance with pharmacopoeias. Confirm GMP certification and conduct supplier audits if necessary.

3. Which regions are best suited for sourcing pharmaceutical-grade BBG?
Europe and North America offer high-quality, regulatory-compliant BBG APIs, but at a higher cost. China and India provide bulk, research-grade APIs with competitive pricing—with due diligence in quality verification.

4. Are there alternatives to Brilliant Blue G for neuroprotection research?
Yes, other P2X7 receptor antagonists such as A-438079 and JNJ-47965567 are available, but BBG remains one of the most widely used due to its efficacy, availability, and cost-effectiveness.

5. What are the key considerations when choosing an API supplier for BBG?
Ensure supplier regulatory compliance, consistent batch quality, appropriate certifications, reliable supply chains, transparent documentation, and adherence to your specific purity requirements.

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References

1. Johnson, A., Smith, B., & Lee, C. (2022). "Supply Chain Dynamics for Synthetic Dyes in Pharmacology." Journal of Pharmaceutical Logistics, 15(3), 45-59.
2. World Health Organization. (2021). Guidelines on Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients.
3. Sigma-Aldrich. (2023). Product datasheet for Brilliant Blue G. Available at: [Sigma-Aldrich website].
4. Chinese Chemical Manufacturers Association. (2022). Annual Report on API Production & Export.
5. U.S. FDA. (2020). Guidance for Industry: API Quality Assurance.

Note: All cited sources are illustrative; consult current industry and regulatory publications for the latest data.