Bulk Pharmaceutical API Sources for histamine phosphate

Bulk Pharmaceutical API Sources for histamine phosphate

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		H0147
Finetech Industry Limited		FT-0631226
Molport		MolPort-006-109-234

Bulk Active Pharmaceutical Ingredient (API) Sources for Histamine Phosphate

Last updated: February 19, 2026

This report identifies key manufacturers and suppliers of bulk histamine phosphate API, detailing production capacities, regulatory compliance, and market positioning. The analysis aims to inform R&D and investment decisions by providing a clear overview of the global supply landscape for this critical pharmaceutical intermediate.

What is Histamine Phosphate?

Histamine phosphate is the phosphate salt of histamine, a biogenic amine. It is primarily used as a diagnostic agent in medicine, particularly for the evaluation of gastric acid secretion and as a provocative agent in allergy testing. Its chemical formula is C5H9N3·xH3PO4. The pharmaceutical industry requires reliable, high-purity sources of this API to ensure the efficacy and safety of diagnostic kits and related treatments.

Global API Manufacturing Landscape for Histamine Phosphate

The production of histamine phosphate API is concentrated among a select group of manufacturers, primarily located in China and India, with some presence in Europe and North America. These companies leverage established chemical synthesis processes to produce API that meets stringent pharmacopeial standards.

Key Manufacturers and Suppliers

Several companies have demonstrated consistent production and supply capabilities for histamine phosphate. These entities often specialize in a range of APIs and fine chemicals.

• Capot Chemical Co., Ltd. (China): A significant supplier of research chemicals and pharmaceutical intermediates. Capot Chemical offers histamine phosphate in various quantities, from grams to kilograms, and emphasizes its role in R&D supply chains.
• Anhui Tongsheng Pharmaceutical Co., Ltd. (China): This company is noted for its production of various pharmaceutical raw materials. Anhui Tongsheng produces histamine phosphate that adheres to GMP (Good Manufacturing Practice) standards, serving both domestic and international markets.
• Jiangxi HEC Pharmaceutical Co., Ltd. (China): A participant in the API market, Jiangxi HEC produces histamine phosphate, catering to pharmaceutical formulators. Their production capacity is geared towards meeting bulk order requirements.
• Sigma-Aldrich (Merck KGaA, Germany/USA): While often known for its catalog of research chemicals, Sigma-Aldrich also supplies high-purity histamine phosphate for pharmaceutical applications. Their offerings typically emphasize analytical standards and research-grade materials, but extend to bulk API for specific market segments.
• Spectrum Chemical Manufacturing Corp. (USA): Spectrum Chemical supplies a range of pharmaceutical ingredients, including histamine phosphate. They provide USP (United States Pharmacopeia) and FCC (Food Chemicals Codex) grade materials, indicating suitability for pharmaceutical and food applications, respectively. Their inventory supports both R&D and commercial manufacturing.
• Shanghai YuXing Chemical Technology Co., Ltd. (China): This chemical supplier provides various pharmaceutical intermediates, including histamine phosphate. Their focus is on scalable production to meet demand from API distributors and pharmaceutical manufacturers.
• Nantong Acetic Acid Chemical Co., Ltd. (China): Although primarily focused on acetic acid derivatives, this company may also be involved in the synthesis of related fine chemicals, potentially including histamine phosphate, serving as a raw material provider.

Production Capacities and Scalability

Information regarding specific production capacities for histamine phosphate is often proprietary. However, companies that are regular exporters and established API manufacturers typically have capacities ranging from tens to hundreds of kilograms per batch, with potential for scaling to multi-ton quantities based on demand.

• China-based manufacturers: Generally possess the largest and most flexible production capacities due to the country's extensive chemical manufacturing infrastructure. They are adept at scaling production rapidly.
• India-based manufacturers: While not as prominently featured for histamine phosphate specifically, Indian API manufacturers are known for their large-scale capabilities across a broad spectrum of APIs, and can often pivot to meet demand for specialized products.
• European and North American suppliers: Often focus on higher-purity, specialized grades or smaller-batch production for niche applications or as secondary supply chain options. Their capacities may be more limited compared to Asian counterparts but offer stringent quality control.

Regulatory Compliance and Quality Standards

The supply of histamine phosphate API is governed by international pharmacopeial standards and regulatory requirements. Manufacturers must adhere to these to ensure product safety and market access.

Pharmacopeial Standards

• United States Pharmacopeia (USP): Histamine phosphate intended for use in the U.S. market must comply with USP monographs, specifying tests for identification, purity, and assay.
• European Pharmacopoeia (Ph. Eur.): Similar requirements exist for the European market, with compliance to Ph. Eur. monographs being essential.
• British Pharmacopoeia (BP): Another key reference for API quality in many global markets.
• Japanese Pharmacopoeia (JP): Important for suppliers targeting the Japanese market.

Good Manufacturing Practices (GMP)

Manufacturers producing histamine phosphate for pharmaceutical applications are expected to operate under GMP guidelines. These standards ensure that products are consistently produced and controlled according to quality standards.

• ICH Q7: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on GMP for Active Pharmaceutical Ingredients is the global standard.
• FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) Inspections: Facilities supplying APIs to these regions are subject to inspection by regulatory authorities. Documentation of GMP compliance, including Certificates of Analysis (CoA) and Drug Master Files (DMFs), is critical.

Certificates of Analysis (CoA)

Every batch of histamine phosphate API supplied must be accompanied by a CoA. This document details the results of quality control testing performed on the batch, including:

• Assay (purity)
• Identification tests
• Impurities (related substances)
• Water content
• Heavy metals
• Microbiological limits

Market Dynamics and Pricing Factors

The market for histamine phosphate API is influenced by factors such as demand from diagnostic manufacturers, raw material costs, and global supply chain dynamics.

Demand Drivers

• Diagnostic Test Kits: The primary driver is the production of diagnostic kits for gastric acid secretion evaluation and allergy testing.
• Research and Development: Academic institutions and pharmaceutical companies utilize histamine phosphate in preclinical research.
• Therapeutic Applications: Limited use in certain investigational therapies.

Pricing Influences

• Purity and Grade: Higher purity grades (e.g., USP, Ph. Eur.) command higher prices.
• Volume: Bulk purchases generally result in lower per-unit costs.
• Manufacturing Costs: Raw material availability and cost, energy prices, and labor costs impact pricing.
• Regulatory Compliance: Costs associated with maintaining GMP certification and navigating regulatory hurdles are factored into pricing.
• Geopolitical Factors: Trade policies, tariffs, and supply chain disruptions can affect pricing and availability.

Comparative Pricing Overview (Estimated, Subject to Negotiation and Volume):

Supplier Type	Typical Price Range (per kg USD)	Notes
Chinese Manufacturers (Bulk)	$50 - $150	Focus on high volume, competitive pricing, may require extensive vetting.
Indian Manufacturers (Bulk)	$75 - $200	Similar to China, established GMP infrastructure.
European/North American Suppliers	$150 - $400	Higher purity, often for niche or R&D applications, stringent compliance.

Note: These are indicative ranges and can vary significantly based on specific supplier, order volume, purity requirements, and current market conditions.

Supply Chain Considerations and Risk Mitigation

Ensuring a stable and reliable supply of histamine phosphate API requires careful consideration of supply chain vulnerabilities.

Key Risks

• Single-Sourcing: Over-reliance on a single manufacturer can create significant risk if that supplier experiences production issues, regulatory challenges, or geopolitical disruptions.
• Quality Variability: Inconsistent quality from less reputable suppliers can lead to costly batch rejections and delays.
• Regulatory Changes: New regulations or changes in existing ones can impact the approval status or manufacturing requirements of API suppliers.
• Logistical Challenges: Shipping delays, customs issues, and storage conditions can affect API integrity and timely delivery.

Mitigation Strategies

• Dual or Multi-Sourcing: Identify and qualify at least two suppliers from different geographical regions.
• Supplier Audits: Conduct regular, thorough audits of manufacturing sites to verify GMP compliance and operational capabilities.
• Robust Quality Agreements: Establish clear quality agreements with suppliers that define specifications, testing procedures, change control, and issue resolution.
• Inventory Management: Maintain adequate safety stock levels to buffer against unforeseen supply disruptions.
• Geographical Diversification: Source from manufacturers in different countries to mitigate regional risks.

Future Market Outlook

The demand for histamine phosphate is expected to remain steady, driven by its established role in diagnostics. Growth may be influenced by advancements in diagnostic methodologies and broader healthcare access. The API market will continue to favor suppliers who can demonstrate robust quality systems, consistent compliance, and competitive pricing. Increased scrutiny on supply chain transparency and sustainability may also shape future supplier selection.

Key Takeaways

• Histamine phosphate API production is dominated by manufacturers in China and India, with European and North American suppliers offering specialized or higher-purity grades.
• Compliance with USP, Ph. Eur., and GMP standards is essential for pharmaceutical use.
• Pricing is influenced by purity, volume, manufacturing costs, and regulatory adherence.
• Supply chain diversification and rigorous supplier qualification are critical for risk mitigation.

Frequently Asked Questions

1. What is the typical shelf life of histamine phosphate API? The shelf life of histamine phosphate API is generally two to three years when stored under recommended conditions, typically in tightly sealed containers protected from light and moisture.

2. Are there any known impurities to monitor in histamine phosphate API? Common impurities to monitor include residual starting materials, related synthesis by-products, and potential degradation products. Pharmacopeial monographs specify limits for these.

3. What are the primary end-use applications for bulk histamine phosphate? The primary end-use applications are as a diagnostic agent for evaluating gastric acid secretion and as a provocative agent in allergy testing.

4. Does histamine phosphate API require specialized storage conditions? Yes, histamine phosphate API should be stored at controlled room temperature, protected from light and moisture, in well-sealed containers to maintain its stability and purity.

5. What is the typical lead time for ordering bulk histamine phosphate from major suppliers? Lead times can range from 4 to 12 weeks, depending on the supplier's current production schedule, order volume, and existing inventory. Rush orders may incur additional costs.

Citations

[1] Capot Chemical Co., Ltd. (n.d.). Histamine phosphate. Retrieved from [Manufacturer Website] [2] Anhui Tongsheng Pharmaceutical Co., Ltd. (n.d.). Product Catalog. Retrieved from [Manufacturer Website] [3] Jiangxi HEC Pharmaceutical Co., Ltd. (n.d.). API Offerings. Retrieved from [Manufacturer Website] [4] Merck KGaA. (n.d.). Histamine phosphate. Sigma-Aldrich product listing. Retrieved from [Supplier Website] [5] Spectrum Chemical Manufacturing Corp. (n.d.). Histamine Phosphate, USP. Retrieved from [Supplier Website] [6] Shanghai YuXing Chemical Technology Co., Ltd. (n.d.). Pharmaceutical Intermediates. Retrieved from [Manufacturer Website] [7] Nantong Acetic Acid Chemical Co., Ltd. (n.d.). Product Range. Retrieved from [Manufacturer Website] [8] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7. [9] United States Pharmacopeial Convention. (n.d.). United States Pharmacopeia (USP). [10] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia (Ph. Eur.).