Bulk Pharmaceutical API Sources for guanidine hydrochloride

Bulk Pharmaceutical API Sources for guanidine hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		G3272_SIGMA
Sigma-Aldrich		G4505_SIGMA
Sigma-Aldrich		G4630_SIGMA
Sigma-Aldrich		G7153_SIGMA
Sigma-Aldrich		G9284_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for: Guanidine Hydrochloride

Last updated: August 21, 2025

Introduction

Guanidine hydrochloride, a potent organic compound, finds varied applications in pharmaceuticals, biochemistry, and industrial chemistry. Known for its strong basicity and ability to denature proteins, it is employed as a chaotropic agent in nucleic acid research, a pharmaceutical intermediate, and in laboratory reagents. As demand for guanidine hydrochloride increases, sourcing reliable, high-quality bulk APIs becomes critical for manufacturers and researchers. This article provides an in-depth analysis of global suppliers, manufacturing pathways, certification standards, and procurement considerations relevant to guanidine hydrochloride as an active pharmaceutical ingredient (API).

Understanding Guanidine Hydrochloride as an API

Guanidine hydrochloride (molecular formula: CH5ClN3) is a highly soluble crystalline compound characterized by its strong basicity and ability to disrupt protein structures. Its applications in the pharmaceutical sector primarily involve biochemical research and laboratory diagnostics rather than direct therapeutic use. Nonetheless, in pharmaceutical manufacturing—particularly in synthesizing intermediates and compounds for drug development—guanidine hydrochloride functions as an essential chemical precursor or reagent.

While not a typical API for oral or injectable drugs, guanidine hydrochloride is classified within APIs used in laboratory manufacturing and bioprocesses. Consequently, sourcing suppliers are often chemical manufacturers with expertise in producing high-grade, pharmaceutical-grade guanidine hydrochloride complying with Good Manufacturing Practices (GMP).

Global Suppliers and Manufacturer Landscape

Leading Manufacturers of Guanidine Hydrochloride

1. Sigma-Aldrich (Merck Group)
   A prominent supplier of laboratory chemicals, Sigma-Aldrich offers pharmaceutical-grade guanidine hydrochloride suitable for research purposes. Their products meet rigorous purity standards (≥99%) and are available in various quantities, from small vials to bulk quantities. Their extensive distribution network ensures global availability.

2. Thermo Fisher Scientific
   As a key player in chemical reagents, Thermo Fisher supplies guanidine hydrochloride, primarily for laboratory and R&D applications. They provide pharmaceutical-grade compounded products adhering to industry standards.

3. Tokyo Chemical Industry (TCI)
   TCI offers high-purity guanidine hydrochloride for research and manufacturing applications. Their consistent quality and global distribution channels position them as a reliable source.

4. Alfa Aesar (Part of Thermo Fisher Scientific)
   Known for specialty chemicals, Alfa Aesar supplies pharmaceutical-grade guanidine hydrochloride, emphasizing purity and compliance with regulatory standards.

5. BASF and Merck (MilliporeSigma)
   Major chemical companies such as BASF and MilliporeSigma produce chemicals suitable as starting materials or intermediates in drug development, including guanidine derivatives.

Regional Suppliers and Emerging Players

• Squire Chemical Industries (India): An emerging supplier of bulk guanidine hydrochloride, mainly serving the Asia-Pacific market, with an emphasis on quality and cost efficiency.

• JRS Pharma (Germany): Specializes in specialty chemicals, including laboratory reagents, with a focus on pharmaceutical compliance.

• Laboratorios Britanico (Latin America): Offers customized chemical synthesis and bulk APIs, including guanidine hydrochloride, targeting regional pharmaceutical industries.

Sources of Pharmaceutical-Grade Guanidine Hydrochloride

For pharmaceutical manufacturing, quality standards such as USP, EP, or JP compliance are non-negotiable. Suppliers who offer GMP-certified guanidine hydrochloride or those with extensive quality documentation and traceability include:

• Merck KGaA (Germany)
• Sigma-Aldrich (Merck)
• Thermo Fisher Scientific
• Alfa Aesar (Thermo Fisher)

These suppliers often provide Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and regulatory compliance documentation.

Manufacturing Pathways and Quality Considerations

Manufacturing Processes

Guanidine hydrochloride is produced via different synthetic routes, including:

• Reaction of Cyanoguanidine with Hydrochloric Acid: The most common method where cyanoguanidine reacts with hydrochloric acid to yield guanidine hydrochloride with high purity.

• Oxidative or Reductive Approaches: Less common, used in specialized syntheses for derivatives or intermediates.

Quality Parameters for API Suppliers

Suppliers must adhere to strict quality standards:

• Purity: ≥99% for pharmaceutical applications
• Impurity Profile: Limited levels of residual solvents and by-products
• Particle Size Distribution: Depending on application, specific particle characteristics are required
• Stability and Packaging: Proper storage conditions to maintain potency and prevent degradation

Regulatory Standards

• USP Monograph: Defines purity and analytical testing methods for laboratory-grade guanidine hydrochloride.
• EP Standards: Pharmaceuticals guidelines applied in Europe for API testing and quality.
• GMP Certification: Essential for supply intended for manufacturing pharmaceuticals.

Procurement Considerations

Assessing Supplier Reliability

• Quality Certifications: GMP, ISO 9001, ISO 13485 (for pharmaceutical and medical device manufacture)
• Traceability: Comprehensive documentation of raw materials, synthesis, and QC data
• Regulatory Compliance: Access to Certificates of Analysis, Material Safety Data Sheets, and regulatory approvals
• Delivery and Lead Time: Capacity for bulk deliveries without compromising quality

Cost and Supply Chain Risks

Given guanidine hydrochloride’s niche status, price volatility may occur due to supply-demand dynamics, geopolitical factors, or raw material availability. Establishing strategic partnerships with multiple suppliers can mitigate supply chain disruptions.

Environmental and Safety Standards

Manufacturers should adhere to environmental regulations concerning waste management and emissions. Proper handling and storage protocols are essential to prevent hazards associated with highly soluble, caustic compounds.

Emerging Trends and Future Outlook

Increasing Demand in Biochemistry and Molecular Biology

The rise of biotechnological research, especially in nucleic acid manipulation and protein denaturation, heightens the demand for high-quality guanidine hydrochloride. This trend urges manufacturers to expand production capacities and reinforce quality standards.

Transition to Alternative Formulations

Research into less toxic or more environmentally friendly chaotropic agents may influence future API sourcing strategies. Nonetheless, guanidine hydrochloride remains fundamental due to its efficacy.

Regulatory Developments

Enhanced standards and validation protocols will drive suppliers toward higher compliance and transparency, influencing procurement decisions for pharmaceutical manufacturing.

Conclusion

Sourcing bulk guanidine hydrochloride as an API requires rigorous evaluation of supplier quality, regulatory compliance, manufacturing standards, and supply chain resilience. Major global chemical suppliers, alongside regionally focused producers, offer pharmaceutical-grade products that meet stringent application requirements. As demand evolves, industry players must prioritize quality assurance and regulatory adherence to maintain uninterrupted, compliant supply chains.

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Key Takeaways

• Quality Over Cost: Prioritize suppliers with GMP certification, comprehensive QC data, and regulatory compliance for pharmaceutical-grade guanidine hydrochloride.

• Supplier Diversification: Maintain relationships with multiple suppliers to mitigate risks associated with supply chain disruptions.

• Regulatory Monitoring: Stay informed about evolving standards (USP, EP, JP) to ensure ongoing compliance.

• Procurement Strategy: Evaluate raw material traceability, purity levels, packaging, and delivery capacity when sourcing large quantities.

• Future Dynamics: Recognize the increasing importance of high-purity quality and regulatory transparency in supplier selection amid expanding biotechnological applications.

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FAQs

1. Is guanidine hydrochloride considered an active pharmaceutical ingredient (API) for therapeutic drugs?
   Typically, no. Guanidine hydrochloride is mainly used as a reagent in research, biochemical, and manufacturing processes. It is classified as an API when used specifically as an industrial or pharmaceutical intermediate or reagent.

2. What quality standards should I look for when sourcing guanidine hydrochloride as an API?
   Look for suppliers providing GMP certification, analytical Grade (≥99% purity), Certificates of Analysis, and compliance with pharmacopeial standards such as USP, EP, or JP.

3. Which regions have the most reliable suppliers of guanidine hydrochloride?
   North America (e.g., Sigma-Aldrich, Thermo Fisher), Europe (MilliporeSigma, TCI), and Asia (Squire Chemical Industries, Shanghai Sinozyme) are prominent regions with established suppliers.

4. Can I source guanidine hydrochloride in bulk for industrial purposes?
   Yes. Major chemical suppliers offer bulk quantities in tonnage. Ensure the supplier’s manufacturing standards and quality documentation align with your application requirements.

5. Are there safety concerns associated with handling guanidine hydrochloride?
   Yes. It is highly soluble and caustic. Proper handling protocols, protective equipment, and storage conditions are essential to ensure safety during procurement and usage.

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References

1. United States Pharmacopeia (USP). Guanidine Hydrochloride Monograph. 2022.
2. European Pharmacopoeia (EP). Guanidine Hydrochloride Monograph. 2023.
3. Merck Group. Materials Data Sheet for Guanidine Hydrochloride. 2022.
4. Sigma-Aldrich. Product Catalog and Technical Data. 2023.
5. Squire Chemical Industries. Product Data Sheet. 2023.