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Histidine | CAS No: 71-00-1 | GMP-certified suppliers
A medication that may support immune modulation and antioxidant activity, primarily investigated for adjunctive use in rheumatoid arthritis treatment.
Therapeutic categories
Primary indications
- The actions of supplemental L-histidine are entirely unclear
- It may have some immunomodulatory as well as antioxidant activity
- L-histidine may be indicated for use in some with rheumatoid arthritis
- It is not indicated for treatment of anemia or uremia or for lowering serum cholesterol
Product Snapshot
- Histidine is available in multiple formulation types including oral tablets, injectable solutions, emulsions, and topical pastes
- It is primarily investigated for potential immunomodulatory and antioxidant activities, with some therapeutic consideration in rheumatoid arthritis
- Histidine products are marketed as investigational or nutraceutical in Canada and the US, without formal regulatory approval for specific medical claims
Clinical Overview
Clinically, supplemental L-histidine’s therapeutic role remains unclear, though it has been investigated for potential immunomodulatory and antioxidant effects. It has been explored as a supportive agent in rheumatoid arthritis due to observed decreases in serum free histidine in affected patients. Despite historical use, histidine is not indicated for anemia, uremia, or cholesterol lowering.
Pharmacodynamically, histidine is abundant in hemoglobin and contributes to various biological functions. Deficiency states have been associated with auditory impairment. Its metabolism involves decarboxylation to histamine, a biologically active amine implicated in immune regulation and inflammatory responses. Histamine acts on H2 receptors found on suppressor T cells and phagocytes, modulating reactive oxygen species (ROS) production and potentially influencing immune cell activity.
Mechanistically, while the precise actions of supplemental L-histidine are speculative, its metal-chelating ability for copper, iron, and zinc suggests a role in mitigating oxidative stress via interference with the Fenton reaction, a source of ROS. Histamine derived from histidine can down-regulate ROS formation in monocytes and promote suppressor T cell function, mechanisms under investigation for conditions such as rheumatoid arthritis, certain cancers, and viral infections.
Pharmacokinetic details are limited, though histidine is absorbed via standard amino acid transport pathways and participates in nitrogen metabolism. Safety profiles of histidine indicate low toxicity within nutritional ranges. However, clinical use as a supplement should consider possible immunological effects. Histidine is categorized as an investigational compound and is also used as a nutraceutical.
From an API sourcing perspective, quality control must ensure purity consistent with amino acid monographs to avoid contamination with structurally related compounds. Pharmaceutical-grade histidine requires rigorous characterization including chiral purity and residual solvents, aligning with regulatory standards for excipients or active ingredients in human-use formulations. Reliable suppliers should provide documentation to support these quality attributes.
Identification & chemistry
| Generic name | Histidine |
|---|---|
| Molecule type | Small molecule |
| CAS | 71-00-1 |
| UNII | 4QD397987E |
| DrugBank ID | DB00117 |
Pharmacology
| Summary | L-histidine serves as a precursor to histamine, which can modulate immune responses by activating suppressor T cells via H2 receptors and reducing reactive oxygen species production in phagocytes. Its chelation of transition metals may also mitigate oxidative tissue damage. These pharmacodynamic properties underlie its potential immunomodulatory and antioxidant effects, particularly in conditions such as rheumatoid arthritis. |
|---|---|
| Mechanism of action | Since the actions of supplemental L-histidine are unclear, any postulated mechanism is entirely speculative. However, some facts are known about L-histidine and some of its metabolites, such as histamine and trans-urocanic acid, which suggest that supplemental L-histidine may one day be shown to have immunomodulatory and/or antioxidant activities. Low free histidine has been found in the serum of some rheumatoid arthritis patients. Serum concentrations of other amino acids have been found to be normal in these patients. L-histidine is an excellent chelating agent for such metals as copper, iron and zinc. Copper and iron participate in a reaction (Fenton reaction) that generates potent reactive oxygen species that could be destructive to tissues, including joints. L-histidine is the obligate precursor of histamine, which is produced via the decarboxylation of the amino acid. In experimental animals, tissue histamine levels increase as the amount of dietary L-histidine increases. It is likely that this would be the case in humans as well. Histamine is known to possess immunomodulatory and antioxidant activity. Suppressor T cells have H2 receptors, and histamine activates them. Promotion of suppressor T cell activity could be beneficial in rheumatoid arthritis. Further, histamine has been shown to down-regulate the production of reactive oxygen species in phagocytic cells, such as monocytes, by binding to the H2 receptors on these cells. Decreased reactive oxygen species production by phagocytes could play antioxidant, anti-inflammatory and immunomodulatory roles in such diseases as rheumatoid arthritis. This latter mechanism is the rationale for the use of histamine itself in several clinical trials studying histamine for the treatment of certain types of cancer and viral diseases. In these trials, down-regulation by histamine of reactive oxygen species formation appears to inhibit the suppression of natural killer (NK) cells and cytotoxic T lymphocytes, allowing these cells to be more effective in attacking cancer cells and virally infected cells. |
| Pharmacodynamics | Is found abundantly in hemoglobin; has been used in the treatment of rheumatoid arthritis, allergic diseases, ulcers and anemia. A deficiency can cause poor hearing. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Histidine decarboxylase | Humans | |
| Histidine--tRNA ligase, cytoplasmic | Humans | |
| Sodium-coupled neutral amino acid transporter 3 | Humans |
ADME / PK
| Absorption | Absorbed from the small intestine via an active transport mechanism requiring the presence of sodium. |
|---|
Formulation & handling
- Histidine is formulated for both oral and parenteral administration, including intravenous and intraperitoneal routes.
- As a small, highly water-soluble molecule with low logP, histidine is stable in aqueous solutions and suitable for injectable preparations.
- No significant peptide or biologic sensitivities are indicated, simplifying handling and storage considerations.
Regulatory status
| Lifecycle | The API's primary patents have expired in both the US and Canada, allowing for generic competition and established market availability in these regions. Market maturity is characterized by multiple authorized generic and brand-name products. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The Histidine supply landscape includes originator companies that supply branded amino acid injection products primarily in the US and Canadian markets. Multiple branded formulations are available, often combined with electrolytes and varying dextrose concentrations. Patent expirations appear to have allowed for generic competition, reflected in the presence of various packagers distributing similar formulations. |
|---|
Safety
| Toxicity | ORL-RAT LD<sub>50</sub> > 15000 mg/kg, IPR-RAT LD<sub>50</sub> > 8000 mg/kg, ORL-MUS LD<sub>50</sub> > 15000 mg/kg, IVN-MUS LD<sub>50</sub> > 2000 mg/kg; Mild gastrointestinal side effects. |
|---|
- Exhibits low acute toxicity with oral LD50 values exceeding 15,000 mg/kg in rats and mice
- Intravenous LD50 in mice is over 2,000 mg/kg, indicating a wide margin of safety in systemic exposure
- Mild gastrointestinal effects observed at high doses
L-Histidine is a type of Amino acids
Amino acids are an essential category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the pharmaceutical industry. These organic compounds are the building blocks of proteins and play a crucial role in various biological processes. With their increasing popularity and therapeutic potential, amino acids have become a focus of research and development in drug discovery.
Amino acids can be classified into two main categories: essential and non-essential. Essential amino acids cannot be synthesized by the body and must be obtained from dietary sources or through pharmaceutical supplementation. Non-essential amino acids, on the other hand, can be synthesized by the body itself.
Pharmaceutical-grade amino acids are produced through a variety of methods, including extraction from natural sources, fermentation, and chemical synthesis. They undergo rigorous quality control procedures to ensure purity, efficacy, and safety. The most common amino acids used as APIs include lysine, valine, leucine, isoleucine, phenylalanine, and methionine, among others.
Amino acids have diverse applications in the pharmaceutical industry. They are widely used as ingredients in parenteral nutrition formulations, where they provide essential nutrients to patients who cannot consume food orally. Additionally, amino acids are utilized in the development of protein-based drugs, such as monoclonal antibodies and recombinant proteins. These pharmaceutical proteins often require specific amino acid sequences to achieve desired therapeutic effects.
In conclusion, amino acids are a vital category of pharmaceutical APIs, playing a significant role in protein synthesis, nutrition, and the development of protein-based drugs. With their extensive applications and growing demand, amino acids continue to contribute to advancements in the pharmaceutical industry.
L-Histidine API manufacturers & distributors
Compare qualified L-Histidine API suppliers worldwide. We currently have 7 companies offering L-Histidine API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Ajinomoto | Producer | Japan | Unknown | CEP, CoA, FDA, GMP, USDMF | 24 products |
| Amino GmbH | Producer | Germany | Unknown | CEP, CoA, FDA, GMP | 17 products |
| Fujifilm Wako Pure Chemic... | Producer | Japan | Japan | BSE/TSE, CoA, GMP, MSDS | 55 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, GMP, ISO9001, USDMF | 157 products |
| Shanghai Kyowa A.A | Producer | China | Unknown | CEP, CoA, FDA, GMP, WC | 12 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS, USDMF | 757 products |
| Wuhan Amino Acid Bio-Chem... | Producer | China | China | CoA | 32 products |
When sending a request, specify which L-Histidine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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