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Histamine | CAS No: 51-45-6 | GMP-certified suppliers
A medication that supports diagnostic evaluation of gastric acid secretory function for specialized gastric function testing across key regulated markets.
Therapeutic categories
Primary indications
- Histamine phosphate is indicated as a diagnostic aid for the evaluation of gastric acid secretory function
Product Snapshot
- Histamine is supplied as a small‑molecule active in injectable and topical formulations
- It is used primarily as a diagnostic aid for assessing gastric acid secretory function
- It has approved and investigational status across the US, Canada, and EU markets
Clinical Overview
Pharmacologically, histamine belongs to the 2‑arylethylamine class and interacts with four G‑protein–coupled receptor subtypes. Activation of H1 receptors produces smooth muscle contraction in bronchial and intestinal tissues and contributes to vasodilation, increased capillary permeability, and edema formation. H2 receptor activation drives gastric acid secretion and mediates relaxation of certain smooth muscle beds while contributing to systemic vasodilation. H3 receptors modulate central and peripheral neurotransmitter release, while H4 receptors influence immune cell chemotaxis.
Key ADME characteristics reflect its role as an endogenous mediator. Histamine is rapidly metabolized by diamine oxidase and histamine N‑methyltransferase, with short systemic persistence and limited distribution due to rapid enzymatic degradation. Exogenous administration in diagnostic contexts results in brief but measurable increases in gastric secretory output.
Safety considerations center on predictable receptor-mediated physiological responses. Vasodilation, flushing, hypotension, bronchoconstriction, abdominal cramping, and headache may occur depending on dose and route. Use requires caution in patients with asthma, cardiovascular instability, peptic ulcer disease, or conditions sensitive to increased gastric acidity. Severe reactions are uncommon at controlled diagnostic doses but may occur with rapid systemic exposure.
Histamine-based preparations are used in specialized gastric function tests rather than routine therapeutic settings. Branded diagnostic formulations may vary by region, but their use is typically restricted to controlled clinical environments.
For API procurement, suppliers should provide material with verified identity, purity, and impurity profiles suitable for diagnostic use. Control of degradation products, adherence to pharmacopoeial specifications, and appropriate handling to prevent oxidation are important for maintaining analytical and clinical reliability.
Identification & chemistry
| Generic name | Histamine |
|---|---|
| Molecule type | Small molecule |
| CAS | 51-45-6 |
| UNII | 820484N8I3 |
| DrugBank ID | DB05381 |
Pharmacology
| Summary | Histamine phosphate acts on H1, H2, H3, and H4 receptors to modulate vascular tone, smooth muscle activity, glandular secretion, neurotransmitter release, and immune cell chemotaxis. Its primary pharmacodynamic effect is stimulation of gastric parietal and chief cells, increasing gastric acid output. In diagnostic use, this predictable activation of gastric secretory pathways supports assessment of gastric acid production. |
|---|---|
| Mechanism of action | Histamine acts directly on the blood vessels to dilate arteries and capillaries; this action is mediated by both H 1- and H 2-receptors. Capillary dilatation may produce flushing of the face, a decrease in systemic blood pressure, and gastric gland secretion, causing an increased secretion of gastric juice of high acidity. Increased capillary permeability accompanies capillary dilatation, producing an outward passage of plasma protein and fluid into the extracellular spaces, an increase in lymph flow and protein content, and the formation of edema. In addition, histamine has a direct stimulant action on smooth muscle, producing contraction if H 1-receptors are activated, or mostly relaxation if H 2-receptors are activated. Also in humans, the stimulant effect of histamine may cause contraction of the intestinal muscle. However, little effect is noticed on the uterus, bladder, or gallbladder. Histamine has some stimulant effect on duodenal, salivary, pancreatic, bronchial, and lacrimal glands. Histamine also can bind to H3 and H4 receptors which are involved in the CNS/PNS neurotransmitter release and immune system chemotaxis, respectively. |
| Pharmacodynamics | Histamine stimulates gastric gland secretion, causing an increased secretion of gastric juice of high acidity. This action is probably due mainly to a direct action on parietal and chief gland cells. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Histamine H1 receptor | Humans | agonist |
| Histamine H2 receptor | Humans | agonist |
| Histamine H3 receptor | Humans | agonist |
ADME / PK
| Absorption | Readily absorbed after parenteral administration. |
|---|---|
| Metabolism | Primarily hepatic. Histamine is rapidly metabolized by methylation and oxidation. Methylation involves ring methylation and catalyzation by the enzyme histamine-N-methyltransferase, producing N-methylhistamine, which is mostly converted to N-methyl imidazole acetic acid. 2 to 3% excreted as free histamine, 4 to 8% as N-methylhistamine, 42 to 47% as N-methyl imidazole acetic acid, 9 to 11% as imidazole acetic acid, and 16 to 23% as imidazole acetic acid riboside. |
Formulation & handling
- High aqueous solubility and low logP support simple aqueous solutions for intradermal, percutaneous, or subcutaneous use, with pH control to maintain amine stability.
- Topical formulations can leverage its hydrophilicity but may require penetration enhancers depending on desired local activity.
- The primary amine structure is prone to oxidation and degradation, so oxygen‑limiting packaging and antioxidant control may be required during handling and storage.
Regulatory status
| Lifecycle | Patent protection is approaching or has recently lapsed across the US, Canada, and the EU, indicating progression toward a mature competitive landscape. As generics enter these regions following expiry, the API is expected to transition into a later lifecycle phase with increasing market commoditization. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Histamine supply is anchored by a single identified originator‑level manufacturer, with several secondary packagers supporting downstream distribution. Branded and compounded histamine products appear in the US, Canada, and parts of the EU, indicating broad market availability. Existing patent expiry means that any relevant exclusivities have lapsed, allowing current or potential generic competition in applicable formulations. |
|---|
Safety
| Toxicity | LD<sub>50</sub>=807 mg/kg (mouse, oral). Side effects can lead to hypertension, hypotension, headache, dizziness, nervousness and tachycardia. Large overdoses can lead to seizures. |
|---|
- Oral LD50 in mice is approximately 807 mg/kg, indicating moderate acute toxicity and the need for controlled handling in laboratory or manufacturing settings
- Exposure may elicit cardiovascular and neurologic effects such as blood pressure fluctuations, tachycardia, headache, dizziness, or nervous system excitation
- Significant overexposure can provoke seizure activity, warranting measures to prevent accidental high‑dose contact during processing
Histamine dihydrochloride is a type of Vasodilators
Vasodilators are a crucial subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a significant role in the management of various cardiovascular conditions. These medications work by widening the blood vessels, promoting increased blood flow and reducing peripheral resistance.
Vasodilators are commonly prescribed to treat hypertension (high blood pressure), angina (chest pain), and heart failure. They are designed to relax and dilate the smooth muscle cells in the walls of blood vessels, leading to improved circulation and reduced strain on the heart.
One widely used class of vasodilators is calcium channel blockers, which prevent calcium from entering the muscle cells of blood vessels. This action inhibits muscle contraction, resulting in widened arteries and enhanced blood flow. Another class is nitric oxide (NO) donors, which release NO, a potent vasodilator, to promote relaxation of vascular smooth muscles.
The therapeutic benefits of vasodilators extend beyond cardiovascular disorders. Some vasodilators, such as minoxidil, have been repurposed for treating male pattern baldness. These medications stimulate hair growth by dilating blood vessels around hair follicles, enhancing nutrient and oxygen delivery.
As with any pharmaceutical API, vasodilators must meet strict quality standards and regulatory guidelines to ensure safety and efficacy. Manufacturers employ sophisticated production processes and stringent quality control measures to guarantee the purity, potency, and stability of these APIs.
In conclusion, vasodilators are a vital subcategory of pharmaceutical APIs used to manage cardiovascular conditions. By expanding blood vessels and enhancing blood flow, vasodilators contribute to improved patient outcomes and play a critical role in the treatment of hypertension, angina, heart failure, and even hair loss.
Histamine dihydrochloride (Vasodilators), classified under Antihypertensive agents
Antihypertensive agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat high blood pressure, also known as hypertension. These medications are designed to lower blood pressure and reduce the risk of associated cardiovascular complications.
Antihypertensive agents function by targeting various mechanisms involved in blood pressure regulation. Some common classes of antihypertensive agents include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers (CCBs), and diuretics.
ACE inhibitors work by inhibiting the enzyme responsible for converting angiotensin I to angiotensin II, a hormone that constricts blood vessels. ARBs, on the other hand, block the receptors to which angiotensin II binds, thereby preventing its vasoconstrictive effects.
Beta-blockers reduce blood pressure by blocking the effects of adrenaline and noradrenaline, which are responsible for increasing heart rate and constricting blood vessels. CCBs inhibit calcium from entering the smooth muscles of blood vessels, resulting in relaxation and vasodilation. Diuretics promote the elimination of excess fluid and sodium from the body, reducing blood volume and thereby lowering blood pressure.
Antihypertensive agents are typically prescribed based on the individual patient's condition and specific needs. They can be used alone or in combination to achieve optimal blood pressure control. It is important to note that antihypertensive agents should be taken regularly as prescribed by a healthcare professional and may require periodic monitoring to ensure their effectiveness and manage any potential side effects.
In summary, antihypertensive agents play a vital role in the management of hypertension by targeting various mechanisms involved in blood pressure regulation. These medications offer significant benefits in reducing the risk of cardiovascular complications associated with high blood pressure.
Histamine dihydrochloride API manufacturers & distributors
Compare qualified Histamine dihydrochloride API suppliers worldwide. We currently have 6 companies offering Histamine dihydrochloride API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| ChemCon GmbH | Producer | Germany | Germany | CoA, GMP, MSDS | 36 products |
| Jubilant Pharmova | Producer | India | India | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF | 52 products |
| Justesa Imagen | Producer | Spain | Spain | CoA, GMP | 15 products |
| Laboratorium Ofichem B.V. | Producer | Netherlands | Netherlands | BSE/TSE, CoA, EDMF/ASMF, FDA, GDP, GMP, ISO9001, MSDS, USDMF | 14 products |
| LEBSA | Producer | Spain | Spain | BSE/TSE, CEP, CoA, Other, EDMF/ASMF, GMP, Other, Other, ISO9001, MSDS | 18 products |
| Pharm Rx Chemical Corp | Distributor | United States | Unknown | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
When sending a request, specify which Histamine dihydrochloride 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.).
Use the list above to find high-quality Histamine dihydrochloride API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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Technical
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Regulatory
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