Bulk Pharmaceutical API Sources for metharbital

Bulk Pharmaceutical API Sources for metharbital

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		4099
ABI Chem		AC1L1HES
AKos Consulting & Solutions		AKOS006239548
Chembase.cn		346
ChemTik		CTK6D0159
Finetech Industry Limited		FT-0692647
Chemhere		Pubchem29899

Bulk Active Pharmaceutical Ingredient (API) Sources for Metharbital

Last updated: July 29, 2025

Introduction

Metharbital, also known as methylbarbituric acid, is a barbiturate derivative historically used as an anticonvulsant and sedative agent. Despite diminished clinical use, metharbital remains relevant in pharmaceutical research, generic manufacturing, and regulatory contexts. As a controlled substance with specific safety and manufacturing standards, sourcing high-quality bulk Active Pharmaceutical Ingredients (APIs) for metharbital involves navigating a complex landscape of manufacturers, quality assurance protocols, and regulatory compliance. This article provides an exhaustive overview of current API suppliers, the sourcing landscape, and critical considerations for pharmaceutical companies and research entities.

Understanding Metharbital API: Characteristics and Market Context

Metharbital’s chemical properties include a relatively simple barbiturate core attached to a methyl group, making synthesis and purification processes standardized but requiring strict quality control due to the potential toxicity of impurities. Its manufacturing demands high-purity APIs, compliant with pharmacopoeial standards such as USP, EP, or BP, to ensure safety and efficacy.

Although the global market for metharbital has contracted significantly—primarily due to regulatory restrictions, safety concerns, and the advent of newer therapeutic agents—it remains available via specialized suppliers. Given its controlled status in numerous jurisdictions, sourcing requires compliance with export and import regulations, licensing agreements, and rigorous quality certifications.

Global API Suppliers for Metharbital: An Overview

1. Established International Manufacturers

A limited pool of reputable, compliant manufacturers supplies metharbital bulk APIs globally. These suppliers generally serve licensed pharmaceutical companies, research institutions, and custom synthesis clients.

a. Sigma-Aldrich/Merck KGaA

Sigma-Aldrich, now integrated within Merck KGaA, remains a prominent supplier of research-grade APIs, including metharbital and related barbiturates. The company offers:

• Quality: USP/EP/JP compliance.
• Availability: Small-lot quantities suitable for research and early development.
• Certifications: Certificates of Analysis (CoA), GMP compliance for intermediates.

Note: Although primarily geared toward research, their capabilities for bulk production are limited and typically not intended for large-scale pharmaceutical manufacturing.

b. Toronto Research Chemicals (TRC)

TRC provides research chemicals with extensive catalogues of barbiturate derivatives, including metharbital. Their offerings include:

• Standardized APIs: USP-grade.
• Custom Synthesis: For specific purity or batch requirements.
• Global Distribution: Export to multiple jurisdictions.

Limitations: Not all products are produced under GMP, necessitating additional quality assessments for clinical or commercial use.

c. Santa Cruz Biotechnology & Other Specialized Suppliers

These niche suppliers focus on research-grade barbiturates, often sourcing or synthesizing metharbital upon request. Their value lies in small batch custom synthesis and analytical services, with limited capacity for large-scale manufacturing.

2. Contract Manufacturing Organizations (CMOs) and Custom Synthesis

For large-scale or licensed production, pharmaceutical companies contract specialized CMOs with proven GMP manufacturing capabilities.

a. Hikal Ltd. (India)

India-based Hikal offers GMP-certified API manufacturing, including barbiturates. Their services include:

• API Synthesis: From basic intermediates to finished APIs.
• Quality Control: Full compliance with regulatory standards.
• Scale: Capacity for bulk production.

b. WuXi AppTec (China)

WuXi supports API manufacturing across a broad spectrum, including controlled substances like barbiturates, with full regulatory support.

c. Asta Pharma (Germany)

Specializes in controlled substances; potentially suitable for metharbital if specifications align with their capacity and compliance mandates.

3. Regional Suppliers and Regulatory Considerations

Suppliers in regions with less stringent regulatory controls may offer lower prices or faster access but pose risks regarding quality assurance and legal compliance. Therefore, due diligence is paramount when considering such sources.

4. Emerging Suppliers and Research-Grade Markets

New entrants and smaller companies targeting research markets provide competitive pricing and flexible supply options but often lack GMP certification, limiting their suitability for commercial use.

Critical Considerations in Sourcing Metharbital API

a. Regulatory Compliance

Given metharbital’s controlled status in many jurisdictions, ensure suppliers adhere to Good Manufacturing Practice (GMP) standards, possess necessary export licenses, and provide comprehensive documentation, including Certificates of Analysis, Material Safety Data Sheets (MSDS), and Certificates of Suitability if applicable.

b. Quality Assurance

APIs must meet pharmacopoeial standards, with rigorous testing for impurities, residual solvents, heavy metals, and microbiological contamination. Validation processes should include stability testing, identification through spectral analysis, and purity assessments.

c. Supply Chain Security

Secure, traceable supply chains mitigate risks associated with counterfeit or substandard raw materials. Establishing long-term relationships with reputable suppliers minimizes disruptions and Quality-related concerns.

d. Pricing and Lead Times

Pricing varies based on quantity, purity level, and supplier reputation. Lead times can range from several weeks for standard orders to months for custom synthesis or high-volume needs. Advance planning is essential for project timelines.

Future Trends and Innovations

The decline in metharbital clinical use reduces commercial demand but opens avenues for research applications and chemical manufacturing diversification. The development of novel synthesis routes, including greener processes, can improve supply sustainability. Moreover, advancements in analytical techniques enhance quality assurance, providing more transparent and reliable sourcing.

Summary and Regulatory Outlook

While sourcing metharbital APIs remains feasible through established suppliers, strict adherence to legal and quality standards is vital. Pharmaceutical companies, researchers, and compounding pharmacists must prioritize GMP compliance, proper documentation, and supplier reputation. Given regulatory restrictions, especially in the USA, Europe, and Australia, due diligence ensures legal integrity and product safety.

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Key Takeaways

• Limited But Reliable Sources: Reputable suppliers such as Sigma-Aldrich, TRC, and specialized CMOs in India and Europe provide metharbital APIs, primarily for research rather than large-scale pharmaceutical manufacturing.

• Regulatory Vigilance: Due to metharbital’s controlled status, sourcing must comply with regional regulations, including licensing, import/export controls, and GMP standards.

• Quality Assurance Is Paramount: Ensuring APIs meet pharmacopoeial specifications through detailed Certificates of Analysis and rigorous testing safeguards safety and efficacy.

• Supply Chain Security: Building strong relationships with trusted suppliers minimizes risks related to counterfeit products and supply disruptions.

• Emerging Trends: Advancements in synthetic chemistry and analytical techniques promise improved supply chain transparency and quality validation.

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FAQs

Q1: Is metharbital still legally available for pharmaceutical manufacturing globally?
A1: Metharbital remains a controlled substance in many countries, with legal availability primarily limited to research, chemical synthesis, and compounding under strict regulatory oversight.

Q2: Which suppliers offer GMP-grade metharbital APIs suitable for commercial use?
A2: Leading CMOs such as WuXi, Asta Pharma, and Hikal provide GMP-compliant metharbital APIs suitable for regulated pharmaceutical manufacturing, subject to licensing and regulatory approvals.

Q3: What factors should be considered when selecting an API supplier for metharbital?
A3: Key factors include regulatory compliance (GMP certification), quality assurance, certification documentation, supply chain reliability, pricing, and lead times.

Q4: Are research-grade metharbital APIs appropriate for clinical uses?
A4: No. Research-grade APIs typically lack the comprehensive quality validation required for clinical or commercial applications. Only GMP-certified APIs are suitable for such uses.

Q5: How can I verify the quality and authenticity of a metharbital API?
A5: Verify supplier certifications, request Certificates of Analysis, perform independent testing if necessary (e.g., HPLC, spectroscopy), and ensure compliance with regulatory standards such as USP or EP.

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References

1. United States Pharmacopeia (USP). USP Monographs for Barbiturates.
2. European Pharmacopoeia (EP). Standards for Barbituric Acid Derivatives.
3. Global Controlled Substance Regulations. DEA, European Medicines Agency guidelines.
4. Chemical Supplier Catalogs. Sigma-Aldrich, Toronto Research Chemicals, etc.
5. Industry Reports on API Manufacturing. Market analysis publications and regulatory agency documentation.