Procurement Report: L-Histidine (CAS 71-00-1)

Product Category: Amino Acid / Pharmaceutical & Food Grade Chemical CAS Number: 71-00-1 Chemical Name: L-Histidine (L-2-Amino-3-(1H-imidazol-5-yl)propanoic acid)

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1. Technical Specifications and Performance Metrics

L-Histidine is a semi-essential, basic amino acid characterized by an imidazole side chain, which provides unique buffering capabilities near physiological pH. For procurement purposes, the following technical parameters define the standard product specifications:

• Purity Standards:
  • Bio/Pharma Grade: Typically ≥99.5% (NT) for analytical and research applications.
  • Pharmacopoeia Grade: Must meet specific monograph requirements for Ph. Eur., USP, ChP, and JP.
  • Impurity Limits: Heavy metals (typically <10 ppm), Loss on Drying (<0.5%), and Residue on Ignition (<0.1%) are standard constraints for high-grade procurement.
• Physical Properties:
  • Appearance: White to off-white crystalline powder.
  • Solubility: Highly soluble in water; practically insoluble in organic solvents like ethanol and ether.
  • LogP: -1.27 (indicating high hydrophilicity).
  • Stability: Stable under standard storage conditions but incompatible with strong oxidizing agents.
• Performance Metrics:
  • Buffering Capacity: Effective in the pH range of 6.0–7.5, making it critical for biological systems.
  • Chelation: Capable of chelating metal ions (e.g., copper, zinc), a key factor in its application in metal-binding formulations.

Procurement Recommendation: When sourcing L-Histidine, explicitly request a Certificate of Analysis (CoA) that validates the ≥99.5% purity threshold and confirms the absence of heavy metals. For applications requiring metal chelation, verify the specific metal-binding capacity data in the technical data sheet (TDS).

2. Industry Compliance and Quality Assurance

L-Histidine is a highly regulated substance due to its dual status as a pharmaceutical ingredient and a food additive. Compliance is non-negotiable for B2B procurement.

• Regulatory Status:
  • FDA: Listed under 21 CFR 172.320 (Amino acids) as a direct food additive.
  • JECFA: Assigned JECFA Number 1431, indicating global safety evaluation.
  • UNII: 4QD397987E (Unique Ingredient Identifier).
• Pharmacopoeial Compliance:
  • Products must adhere to monographs from USP (United States Pharmacopeia), Ph. Eur. (European Pharmacopoeia), ChP (Chinese Pharmacopoeia), and JP (Japanese Pharmacopoeia).
  • Reference Standards: For quality control, procurement of USP/EP Reference Standards (e.g., 25 mg or 200 mg vials) is recommended for internal calibration.
• Cosmetic Regulations:
  • Recognized for skin conditioning, antistatic, and humectant functions in cosmetic formulations.

Procurement Recommendation: Prioritize suppliers who can provide full traceability documentation and CoAs aligned with the specific pharmacopoeia required by your end-market (e.g., USP for US markets, Ph. Eur. for EU). Avoid suppliers who cannot confirm JECFA compliance if the product is intended for global food distribution.

3. Cost Efficiency and Integration Capabilities

The cost of L-Histidine varies significantly based on purity grade, packaging size, and regulatory compliance level.

• Pricing Structure (Estimated B2B Ranges):
  • Analytical/Reference Standard: $250 – $550 per unit (25 mg – 200 mg).
  • Laboratory Grade (25g): ~$80 – $100.
  • Pharmacopoeia Grade (0.5 kg – 1 kg): $600 – $1,100 per kg.
  • Bulk Industrial Grade: Note: Exact bulk pricing is not in source data; typical B2B ranges for food/pharma grade bulk (50kg+) often range from $15–$30/kg depending on market volatility.
• Packaging Options:
  • Small scale: 25 mg, 25 g, 200 mg (vials).
  • Medium scale: 0.5 kg, 1 kg (bags/bottles).
  • Bulk scale: 25 kg, 50 kg drums (typically custom quote).
• Integration Capabilities:
  • Chemical Compatibility: Compatible with standard aqueous processing. Incompatible with strong oxidizers; storage tanks must be free of oxidizing residues.
  • Logistics: Stable solid; requires standard dry storage. No special temperature control needed unless specified for long-term stability (>2 years).

Procurement Recommendation: For R&D departments, purchasing smaller quantities of "BioUltra" or "Reference Standard" grades is cost-effective for validation. For production, negotiate contracts for Pharmacopoeia-grade (EMPROVE EXPERT or equivalent) in 1kg or larger increments to reduce per-unit costs. Always factor in the cost of reference standards for in-house QC testing.

4. Typical Use Cases

L-Histidine is versatile across multiple industries due to its buffering and metal-chelating properties.

• Pharmaceuticals & Biotechnology:
  • Buffering Agent: Essential in cell culture media and protein formulation buffers to maintain physiological pH.
  • Nutritional Supplement: Used in parenteral nutrition and amino acid infusions for patients with metabolic disorders.
  • Chelation Therapy: Utilized in formulations to bind excess copper or zinc.
• Food & Beverage:
  • Fortification: Added to infant formulas and sports drinks as an essential amino acid.
  • Preservative/Flavor: Used to enhance flavor profiles and extend shelf life in specific food matrices.
• Cosmetics & Personal Care:
  • Skin Conditioning: Acts as a humectant to retain moisture.
  • Antistatic: Used in hair care products to reduce static electricity.
• Analytical Chemistry:
  • Calibration: Used as a primary standard for HPLC and titration methods.

Procurement Recommendation: Match the grade to the application. Do not use "BioUltra" grade for large-scale food fortification unless cost is not a primary constraint; instead, specify "Food Grade" or "Pharmacopoeia Grade" for bulk applications. For cosmetic formulations, ensure the supplier confirms the "Skin Conditioning" and "Humectant" functional claims in the product description.

5. Long-Term Planning Considerations

• Market Trends & Demand Signals:
  • Growth Drivers: Increasing demand for high-purity amino acids in biopharmaceutical manufacturing (especially cell and gene therapy) is driving demand for USP/EP grade L-Histidine.
  • Regulatory Tightening: Stricter FDA and EU regulations on amino acid purity and heavy metal content may increase the cost of non-compliant suppliers.
  • Supply Chain Stability: L-Histidine is a stable commodity, but supply can be affected by agricultural harvest cycles (if derived from fermentation) and geopolitical factors affecting chemical logistics.
• Durability & Shelf Life:
  • The substance is stable under normal conditions. However, procurement planning should account for potential degradation if exposed to moisture or strong oxidizers.
  • Recommended shelf life for bulk stock: 24–36 months in sealed, dry conditions.
• Sustainability:
  • Fermentation-based production is the dominant method. Procurement strategies should prioritize suppliers with documented sustainable fermentation practices to meet ESG goals.

Procurement Recommendation: Establish long-term contracts with suppliers who hold multiple pharmacopoeial certifications (USP, Ph. Eur., ChP) to mitigate regulatory risk. Monitor the "Reference Standard" market prices as an indicator of high-end demand trends. Plan inventory buffers for 6–12 months to account for potential supply chain disruptions in the biopharma sector.

6. Special Product Recommendations

The following table compares available product types based on the provided search context to assist in selecting the right procurement path.

| Product Type | Best-Fit Buyer | Key Specs | Risk Check | Procurement Advice | | :--- | :--- | :--- | :--- :--- | | EP/USP Reference Standard | Quality Control Labs, R&D | 25 mg – 200 mg; Certified Reference Material | High Cost per gram; Small volume | Purchase only when validating analytical methods; essential for regulatory audits. | | BioUltra Grade (≥99.5%) | Research Laboratories | 25g; ≥99.5% (NT); High Purity | Moderate Cost; Limited bulk availability | Ideal for small-batch synthesis and non-GMP research; verify lot-to-lot consistency. | | Pharmacopoeia Grade (EMPROVE) | Pharma Manufacturers, Bulk Buyers | 0.5 kg – 1 kg; Ph. Eur., ChP, JP, USP compliant | Higher MOQ; Complex Compliance | Best for production scaling; ensures regulatory acceptance in multiple regions. | | Generic Food Grade | Food Processors | Bulk (50kg+); JECFA 1431 compliant | Variable Purity; Lower Cost | Verify heavy metal limits strictly; suitable for fortification but not for injectables. |

Procurement Recommendation: For immediate needs in analytical validation, procure the Reference Standard from a reputable supplier like Sigma-Aldrich to ensure data integrity. For production scaling, the Pharmacopoeia Grade (0.5kg/1kg) offers the best balance of compliance and cost-efficiency. Avoid generic grades for pharmaceutical applications.

7. Frequently Asked Questions (FAQ)

Q1: What is the CAS number for L-Histidine? A: The CAS number is 71-00-1. This is the unique identifier used globally for procurement and regulatory tracking.

Q2: Is L-Histidine safe for use in food and cosmetics? A: Yes. It is listed in FDA 21 CFR 172.320 as a direct food additive and is recognized by JECFA (Number 1431). In cosmetics, it functions as a skin conditioning, antistatic, and humectant agent.

Q3: What is the difference between "BioUltra" and "Pharmacopoeia" grade? A: "BioUltra" (e.g., ≥99.5%) is typically intended for research and analytical use with high purity but may not meet the full monograph requirements for human consumption. "Pharmacopoeia" grade (USP, Ph. Eur., etc.) is certified for use in pharmaceuticals and food, meeting strict limits for impurities and heavy metals.

Q4: How stable is L-Histidine during storage? A: It is chemically stable under standard conditions. However, it is incompatible with strong oxidizing agents. It should be stored in a cool, dry place away from oxidizers to maintain integrity.

Q5: What are the typical packaging sizes available? A: Available sizes range from small analytical vials (25 mg, 200 mg) to laboratory bottles (25 g) and bulk containers (0.5 kg, 1 kg). Larger bulk quantities (e.g., 25 kg drums) are typically available via custom quote.

Q6: Can L-Histidine be used as a buffer in cell culture? A: Yes. Due to its imidazole side chain, it is an excellent buffering agent in the physiological pH range (6.0–7.5) and is commonly used in cell culture media.

Q7: What is the typical lead time for bulk orders? A: While exact lead times vary by supplier, standard B2B lead times for Pharmacopoeia grade in 1kg quantities are typically 1–3 weeks. Bulk orders (50kg+) may require 4–8 weeks depending on manufacturer capacity.

Q8: Are there specific heavy metal limits I should check? A: Yes. For Pharmacopoeia grades, heavy metal limits are typically <10 ppm. Always request a CoA to verify the specific heavy metal analysis for your batch.