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Magnesium gluconate | CAS No: 59625-89-7 | GMP-certified suppliers
A medication that prevents and treats magnesium deficiency to support normal cellular, muscular, neurological, bone, and cardiovascular functions in patients with chronic magnesium loss.
Therapeutic categories
Acids, AcyclicAgents that produce neuromuscular block (indirect)Alimentary Tract and MetabolismCarbohydratesHydroxy AcidsMagnesium Compounds
Generic name
Magnesium gluconate
Molecule type
small molecule
CAS number
59625-89-7
DrugBank ID
DB13749
Approval status
Approved drug, Investigational drug
ATC code
A12CC03
Primary indications
- Magnesium gluconate is a mineral supplement which is used to prevent and treat low levels of magnesium
- Magnesium is very important for the normal physiologic functioning of cells, nerves, muscles, bones, and the heart
- Generally, a well-balanced diet provides the necessary amounts of magnesium for homeostasis
- However, certain conditions causing chronic magnesium deficiency may decrease levels of magnesium
Product Snapshot
- Magnesium gluconate is available as oral tablets, capsules, solutions, and intravenous formulations
- It is primarily indicated as a mineral supplement for preventing and treating magnesium deficiency caused by various conditions
- This API is approved and marketed in key regulatory regions including the US and Canada
Clinical Overview
Magnesium gluconate is a magnesium salt of gluconic acid used primarily as a mineral supplement to prevent and treat magnesium deficiency. Magnesium is a vital mineral involved in numerous physiological processes, including the normal functioning of cells, nerves, muscles, bones, and the cardiovascular system. While magnesium is commonly present in various foods and pharmaceutical products such as antacids and laxatives, supplementation may be necessary in cases of chronic deficiency resulting from conditions like diuretic use, poor diet, alcoholism, gastrointestinal malabsorption, severe diarrhea or vomiting, and poorly controlled diabetes.
Pharmacologically, magnesium acts as a cofactor for over 300 enzymatic systems involved in critical biochemical reactions, including energy production through oxidative phosphorylation and glycolysis, protein synthesis, carbohydrate metabolism, and regulation of blood glucose and blood pressure. Magnesium gluconate specifically has demonstrated higher oral bioavailability compared to other magnesium salts, leading to more efficient absorption and lower incidence of gastrointestinal side effects such as diarrhea.
The mechanism of action of magnesium gluconate involves restoring deficient circulating magnesium levels. Magnesium competes with calcium for membrane-binding sites and facilitates calcium sequestration within the sarcoplasmic reticulum, thereby maintaining low intracellular free calcium concentrations essential for cellular function. It also influences electrical membrane properties and ion transport processes important in nerve impulse conduction, muscle contraction, and cardiac rhythm regulation. Additionally, magnesium supports structural bone development and is involved in nucleic acid (DNA, RNA) synthesis and antioxidant activities.
Clinical investigations have explored the use of magnesium gluconate in pregnancy-related conditions, including prevention of pregnancy-induced hypertension and reduction of premature uterine contractions. Supplementation during pregnancy may contribute to improved fetal growth parameters and decreased risk of pre-eclampsia, although such uses remain investigational.
From a safety perspective, magnesium gluconate is generally well-tolerated with fewer gastrointestinal adverse effects compared to other magnesium salts. Nonetheless, caution is advised in patients with renal impairment or those receiving concomitant therapies affecting magnesium homeostasis.
For pharmaceutical development and regulatory compliance, sourcing of magnesium gluconate active pharmaceutical ingredient (API) should ensure adherence to pharmacopeial standards with respect to purity, assay, and absence of toxic elemental impurities. Consistent quality and reliable supply chains are critical for maintaining the efficacy and safety profiles of formulations containing this API.
Pharmacologically, magnesium acts as a cofactor for over 300 enzymatic systems involved in critical biochemical reactions, including energy production through oxidative phosphorylation and glycolysis, protein synthesis, carbohydrate metabolism, and regulation of blood glucose and blood pressure. Magnesium gluconate specifically has demonstrated higher oral bioavailability compared to other magnesium salts, leading to more efficient absorption and lower incidence of gastrointestinal side effects such as diarrhea.
The mechanism of action of magnesium gluconate involves restoring deficient circulating magnesium levels. Magnesium competes with calcium for membrane-binding sites and facilitates calcium sequestration within the sarcoplasmic reticulum, thereby maintaining low intracellular free calcium concentrations essential for cellular function. It also influences electrical membrane properties and ion transport processes important in nerve impulse conduction, muscle contraction, and cardiac rhythm regulation. Additionally, magnesium supports structural bone development and is involved in nucleic acid (DNA, RNA) synthesis and antioxidant activities.
Clinical investigations have explored the use of magnesium gluconate in pregnancy-related conditions, including prevention of pregnancy-induced hypertension and reduction of premature uterine contractions. Supplementation during pregnancy may contribute to improved fetal growth parameters and decreased risk of pre-eclampsia, although such uses remain investigational.
From a safety perspective, magnesium gluconate is generally well-tolerated with fewer gastrointestinal adverse effects compared to other magnesium salts. Nonetheless, caution is advised in patients with renal impairment or those receiving concomitant therapies affecting magnesium homeostasis.
For pharmaceutical development and regulatory compliance, sourcing of magnesium gluconate active pharmaceutical ingredient (API) should ensure adherence to pharmacopeial standards with respect to purity, assay, and absence of toxic elemental impurities. Consistent quality and reliable supply chains are critical for maintaining the efficacy and safety profiles of formulations containing this API.
Identification & chemistry
| Generic name | Magnesium gluconate |
|---|---|
| Molecule type | Small molecule |
| CAS | 59625-89-7 |
| UNII | T42NAD2KHC |
| DrugBank ID | DB13749 |
Pharmacology
| Summary | Magnesium gluconate serves as a magnesium supplement to restore deficient circulating magnesium levels essential for cellular homeostasis. Magnesium acts as a cofactor in over 300 enzymatic reactions involved in protein synthesis, energy metabolism, and nucleic acid synthesis, while modulating cellular ion transport and membrane electrical properties. Its pharmacodynamic effects support nerve conduction, muscle contraction, and cardiovascular function through regulation of intracellular calcium and potassium ion concentrations. |
|---|---|
| Mechanism of action | Replaces deficient circulating levels of magnesium . By competing with calcium for membrane binding sites and by stimulating calcium sequestration by sarcoplasmic reticulum, magnesium helps in the maintenance of a low resting intracellular free calcium ion concentration, which is essential in various cellular functions. The electrical properties of membranes and their permeability characteristics are also affected by magnesium . Magnesium is essential to many enzymatic reactions in the body, serving as a cofactor in protein synthesis and in carbohydrate metabolism . Magnesium contributes to the structural development of bone and is also essential in the synthesis of DNA, RNA, and the antioxidant glutathione. Magnesium also plays an important role in the active transport of calcium and potassium ions across cell membranes, a process which is important to nerve impulse conduction, muscle contraction, and normal heart rhythm . In addition to the above, magnesium is an essential mineral required for the regulation of body temperature, nucleic acid and protein synthesis, and in preserving nerve and muscle cell electrical potentials. Magnesium supplementation during pregnancy may help to reduce fetal growth restriction and pre-eclampsia, as well to increase birth weight . |
| Pharmacodynamics | Magnesium is a cofactor in over 300 enzyme systems that regulate a variety of biochemical reactions in the body, including protein synthesis, muscle and nerve function, blood glucose control, and blood pressure regulation. Magnesium is necessary for energy production, oxidative phosphorylation, and glycolysis . |
ADME / PK
| Absorption | A high-fat diet may decrease the amount of magnesium absorbed in the diet. Over-cooking food also may decrease the amount of magnesium absorbed from dietary sources . About 1/3 of magnesium is absorbed from the small intestine. The fraction of magnesium absorbed is inversely proportional to amount ingested . Oral absorption is estimated to be 15% to 30% . |
|---|---|
| Protein binding | Approximately 25-30% . Of the protein bound fraction, 60–70% is associated with albumin and the rest is bound to other globulins . |
| Route of elimination | Oral: Via urine (absorbed fraction); feces (unabsorbed fraction) . Phosphate depletion is associated with a significant increase in urinary magnesium excretion and may lead to hypomagnesemia. Hypercalcemia is associated with an increased urinary excretion of magnesium. The increase in magnesium excretion in hypercalcemia is greater than the increase in calcium excretion and is due to decreased reabsorption in the loop of Henle. Hypercalcaemia leads to a reduction in isotonic reabsorption in the proximal renal tubule causing greater delivery of sodium, water, calcium and magnesium to the loop of Henle. As a result of this increased flow to thick ascending loop of henle, calcium and magnesium transport may be inhibited. In addition, the high peritubular concentration of calcium directly inhibits the transport of both ions in this segment . Osmotic diuretics such as mannitol and glucose cause a marked increase in magnesium excretion. Loop diuretics induce hypermagnesuria, and the increase in magnesium excretion is greater than that of sodium or calcium suggesting that loop diuretics may directly inhibit magnesium transport . |
| Volume of distribution | About 60% of the magnesium is present in bone, of which 30% is exchangeable and functions as a reservoir to stabilize the serum concentration. About 20% is found in skeletal muscle, 19% in other soft tissues and less than 1% in the extracellular fluid. Skeletal muscle and liver contain between 7–9 mmol/Kg wet tissue; between 20–30% of this is readily exchangeable. In healthy adults, the total serum magnesium is in the range of 0.70 and 1.10 mmol/L. Approximately 20% of this is protein bound, 65% is ionized and the rest is combined with various anions such as phosphate and citrate . |
| Clearance | The kidney plays a major role in magnesium homeostasis and the maintenance of plasma magnesium concentration. Under normal circumstances, when 80% of the total plasma magnesium is ultrafiltrable, 84 mmol of magnesium is filtered daily and 95% of this amount it reabsorbed leaving about 3–5 mmol to be excreted in the urine . |
Formulation & handling
- Magnesium gluconate is a small molecule suitable for both oral and intravenous administration.
- It exhibits high water solubility, facilitating formulation in aqueous solutions and parenteral products.
- As a stable sugar acid derivative, minimal special handling precautions are required beyond standard moisture and light protection.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) has passed patent expiration in both the US and Canada, supporting the availability of generic formulations and reflecting a mature market with established competition. Continued regulatory approvals maintain its presence across these regions. |
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| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Magnesium gluconate is supplied by multiple originator companies with branded products available primarily in the US and Canadian markets. The presence of various formulations, including tablets and liquid supplements, indicates a well-established supply landscape. Patent expiration status suggests existing generic competition alongside branded options. |
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Safety
| Toxicity | Oral LD50 is 9100 mg/kg in the rat . Excess magnesium from dietary sources does not pose a health risk in healthy individuals because the kidneys eliminate excess amounts of magnesium in the urine. On the other hand, high doses of magnesium from dietary supplements or medications often result in diarrhea that can be combined with nausea and abdominal cramping. Forms of magnesium most commonly reported to cause diarrhea include magnesium carbonate, chloride, gluconate, and oxide. Diarrheal and laxative effects of magnesium salts are due to the osmotic activity of unabsorbed salts in the intestine and colon and the stimulation of gastric motility . Hypermagnesaemia after oral ingestion is uncommon except in patients with renal impairment. Signs and symptoms of hypermagnesemia may include respiratory depression, loss of deep tendon reflexes due to neuromuscular blockade, nausea, vomiting, flushing, hypotension, drowsiness, bradycardia and muscle weakness. Very high doses of magnesium-containing laxatives and antacids (normally providing more than 5,000 mg/day magnesium) have been associated with the occurrence of magnesium toxicity, including fatal hypermagnesemia in a 28-month-old boy as well as an elderly man. Symptoms of magnesium toxicity, normally presenting at concentrations of 1.74–2.61 mmol/L, may include hypotension, nausea, vomiting, facial flushing, retention of urine, ileus, depression, and lethargy before progressing to muscle weakness, difficulty breathing, extreme hypotension, irregular heartbeat, and cardiac arrest. The risk of magnesium toxicity increases with compromised renal function or kidney failure because the ability to remove excess magnesium is reduced or lost . Treatment: In patients with normal renal function, IV fluids or furosemide may be administered to promote the excretion of magnesium. In patients with symptomatic hypermagnesaemia, slow IV injection of calcium gluconate can be administered to antagonize the cardiac and neuromuscular effects of magnesium . |
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High Level Warnings:
- Oral LD50 in rats is 9100 mg/kg, indicating low acute toxicity
- Excessive intake may cause gastrointestinal effects such as diarrhea, nausea, and abdominal cramping due to osmotic activity of unabsorbed salts
- Risk of hypermagnesemia and associated neuromuscular and cardiac symptoms increases in individuals with impaired renal function
Magnesium gluconate is a type of Electrolytes
Electrolytes are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) that play a vital role in maintaining the balance of essential ions in the body. These ions include sodium, potassium, calcium, magnesium, and chloride, among others. Electrolytes are responsible for maintaining proper hydration, regulating nerve and muscle function, and supporting various physiological processes.
In the pharmaceutical industry, electrolytes are widely utilized in the formulation of oral rehydration solutions, intravenous fluids, and dialysis solutions. These medications are employed to treat conditions such as dehydration, electrolyte imbalances, and renal dysfunction.
The availability of high-quality electrolyte APIs is of utmost importance to ensure the efficacy and safety of these pharmaceutical products. Pharmaceutical manufacturers rely on reputable suppliers who adhere to stringent quality control measures and comply with Good Manufacturing Practices (GMP) to produce electrolyte APIs of consistent quality.
To meet regulatory requirements, electrolyte APIs undergo rigorous testing to confirm their identity, purity, and potency. This includes analysis using advanced techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and atomic absorption spectroscopy (AAS).
In conclusion, electrolytes are a vital category of pharmaceutical APIs used to maintain the balance of essential ions in the body. They are extensively employed in various medications aimed at treating dehydration, electrolyte imbalances, and renal dysfunction. Pharmaceutical manufacturers prioritize the use of high-quality electrolyte APIs to ensure the safety and efficacy of their products, and adherence to stringent regulatory standards is crucial in their production and testing processes.
Magnesium gluconate API manufacturers & distributors
Compare qualified Magnesium gluconate API suppliers worldwide. We currently have 4 companies offering Magnesium gluconate API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Acta minerals | Producer | Netherlands | Netherlands | BSE/TSE, CoA, GMP, MSDS | 67 products |
| Dr. Paul Lohmann GmbH & C... | Producer | Germany | Germany | CoA, EDMF/ASMF, GMP, MSDS, USDMF | 49 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, GMP, MSDS | 174 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
When sending a request, specify which Magnesium gluconate 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 Magnesium gluconate 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.
