Find U.S.P. Magnesium Gluconate manufacturers, exporters & distributors on PharmaCompass

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Chemistry

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Also known as: 59625-89-7, Magnesium gluconate,dihydrate, Magnesium gluconate dihydrate, Magnesium d-gluconate (1:2) hydrate, Magnesium gluconicum, Magnesium gluconate, dihydrate
Molecular Formula
C12H26MgO16
Molecular Weight
450.63  g/mol
InChI Key
HJWFTNWQKDPLAS-SYAJEJNSSA-L
FDA UNII
T42NAD2KHC

U.S.P. Magnesium Gluconate
Magnesium gluconate is a magnesium salt of gluconate. It demonstrates the highest oral bioavailability of magnesium salts and is used as a mineral supplement. Magnesium is ubiquitous in the human body, and is naturally present in many foods, added to other food products, available as a dietary supplement and used as an ingredient in some medicines (such as antacids and laxatives). Although magnesium is available in the form of sulphates, lactate, hydroxide, oxide and chloride, only magnesium gluconate is recommended for magnesium supplementation as it appears to be better absorbed and causes less diarrha. This drug has been studied in the prevention of pregnancy-induced hypertension, and has displayed promising results. In addition, it has been studied for its effects on premature uterine contractions.
1 2D Structure

U.S.P. Magnesium Gluconate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
magnesium;(2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanoate;dihydrate
2.1.2 InChI
InChI=1S/2C6H12O7.Mg.2H2O/c2*7-1-2(8)3(9)4(10)5(11)6(12)13;;;/h2*2-5,7-11H,1H2,(H,12,13);;2*1H2/q;;+2;;/p-2/t2*2-,3-,4+,5-;;;/m11.../s1
2.1.3 InChI Key
HJWFTNWQKDPLAS-SYAJEJNSSA-L
2.1.4 Canonical SMILES
C(C(C(C(C(C(=O)[O-])O)O)O)O)O.C(C(C(C(C(C(=O)[O-])O)O)O)O)O.O.O.[Mg+2]
2.1.5 Isomeric SMILES
C([C@H]([C@H]([C@@H]([C@H](C(=O)[O-])O)O)O)O)O.C([C@H]([C@H]([C@@H]([C@H](C(=O)[O-])O)O)O)O)O.O.O.[Mg+2]
2.2 Other Identifiers
2.2.1 UNII
T42NAD2KHC
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Boron Gluconate

2. D-gluconate

3. D-gluconic Acid

4. Dextronic Acid

5. Gluconate

6. Gluconic Acid

7. Gluconic Acid, (113)indium-labeled

8. Gluconic Acid, (14)c-labeled

9. Gluconic Acid, (159)dysprosium-labeled Salt

10. Gluconic Acid, (99)technecium (5+) Salt

11. Gluconic Acid, 1-(14)c-labeled

12. Gluconic Acid, 6-(14)c-labeled

13. Gluconic Acid, Aluminum (3:1) Salt

14. Gluconic Acid, Ammonium Salt

15. Gluconic Acid, Calcium Salt

16. Gluconic Acid, Cesium(+3) Salt

17. Gluconic Acid, Cobalt (2:1) Salt

18. Gluconic Acid, Copper Salt

19. Gluconic Acid, Fe(+2) Salt, Dihydrate

20. Gluconic Acid, Lanthanum(+3) Salt

21. Gluconic Acid, Magnesium (2:1) Salt

22. Gluconic Acid, Manganese (2:1) Salt

23. Gluconic Acid, Monolithium Salt

24. Gluconic Acid, Monopotassium Salt

25. Gluconic Acid, Monosodium Salt

26. Gluconic Acid, Potassium Salt

27. Gluconic Acid, Sodium Salt

28. Gluconic Acid, Strontium (2:1) Salt

29. Gluconic Acid, Tin(+2) Salt

30. Gluconic Acid, Zinc Salt

31. Lithium Gluconate

32. Magnerot

33. Maltonic Acid

34. Manganese Gluconate

35. Pentahydroxycaproic Acid

36. Sodium Gluconate

37. Zinc Gluconate

2.3.2 Depositor-Supplied Synonyms

1. 59625-89-7

2. Magnesium Gluconate,dihydrate

3. Magnesium Gluconate Dihydrate

4. Magnesium D-gluconate (1:2) Hydrate

5. Magnesium Gluconicum

6. Magnesium Gluconate, Dihydrate

7. Magnesium D-gluconate (1:2) Dihydrate

8. Magnesium (as Gluconate)

9. T42nad2khc

10. E-580(magnesium Gluconate)

11. Ins-580(magnesium Gluconate)

12. Ins No.580(magnesium Gluconate)

13. Magnesium Gluconate [usp]

14. D-gluconic Acid, Magnesium Salt (2:1), Hydrate

15. Unii-t42nad2khc

16. Magnesium Gluconate [ep]

17. Chembl3989640

18. Magnesium Gluconate [fcc]

19. Magnesium Gluconate [inci]

20. Magnesium Gluconate [vandf]

21. Magnesium Gluconate [mart.]

22. Db13749

23. Magnesium (as Gluconate) [vandf]

24. Magnesium Gluconate [ep Monograph]

25. Magnesium Gluconate [usp Monograph]

26. Magnesium Gluconate,dihydrate [vandf]

27. W-105312

28. Q27888486

29. Magnesium (2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanoate Dihydrate

30. Magnesium;(2r,3s,4r,5r)-2,3,4,5,6-pentahydroxyhexanoate;dihydrate

2.4 Create Date
2013-07-08
3 Chemical and Physical Properties
Molecular Weight 450.63 g/mol
Molecular Formula C12H26MgO16
Hydrogen Bond Donor Count12
Hydrogen Bond Acceptor Count16
Rotatable Bond Count8
Exact Mass450.1071264 g/mol
Monoisotopic Mass450.1071264 g/mol
Topological Polar Surface Area285 Ų
Heavy Atom Count29
Formal Charge0
Complexity165
Isotope Atom Count0
Defined Atom Stereocenter Count8
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count5
4 Drug and Medication Information
4.1 Drug Indication

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. These conditions include treatment with diuretics, a poor diet, alcoholism, or other medical conditions (e.g., severe diarrhea/vomiting, stomach/intestinal absorption problems, poorly controlled diabetes).


5 Pharmacology and Biochemistry
5.1 Pharmacology

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.


5.2 ATC Code

A - Alimentary tract and metabolism

A12 - Mineral supplements

A12C - Other mineral supplements

A12CC - Magnesium

A12CC03 - Magnesium gluconate


5.3 Absorption, Distribution and Excretion

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%.


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 79 mmol/Kg wet tissue; between 2030% 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 35 mmol to be excreted in the urine.


5.4 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.


ABOUT THIS PAGE

U.S.P. Magnesium Gluconate Manufacturers

A U.S.P. Magnesium Gluconate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of U.S.P. Magnesium Gluconate, including repackagers and relabelers. The FDA regulates U.S.P. Magnesium Gluconate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. U.S.P. Magnesium Gluconate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

U.S.P. Magnesium Gluconate Suppliers

A U.S.P. Magnesium Gluconate supplier is an individual or a company that provides U.S.P. Magnesium Gluconate active pharmaceutical ingredient (API) or U.S.P. Magnesium Gluconate finished formulations upon request. The U.S.P. Magnesium Gluconate suppliers may include U.S.P. Magnesium Gluconate API manufacturers, exporters, distributors and traders.

click here to find a list of U.S.P. Magnesium Gluconate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

U.S.P. Magnesium Gluconate USDMF

A U.S.P. Magnesium Gluconate DMF (Drug Master File) is a document detailing the whole manufacturing process of U.S.P. Magnesium Gluconate active pharmaceutical ingredient (API) in detail. Different forms of U.S.P. Magnesium Gluconate DMFs exist exist since differing nations have different regulations, such as U.S.P. Magnesium Gluconate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A U.S.P. Magnesium Gluconate DMF submitted to regulatory agencies in the US is known as a USDMF. U.S.P. Magnesium Gluconate USDMF includes data on U.S.P. Magnesium Gluconate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The U.S.P. Magnesium Gluconate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of U.S.P. Magnesium Gluconate suppliers with USDMF on PharmaCompass.

U.S.P. Magnesium Gluconate GMP

U.S.P. Magnesium Gluconate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of U.S.P. Magnesium Gluconate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right U.S.P. Magnesium Gluconate GMP manufacturer or U.S.P. Magnesium Gluconate GMP API supplier for your needs.

U.S.P. Magnesium Gluconate CoA

A U.S.P. Magnesium Gluconate CoA (Certificate of Analysis) is a formal document that attests to U.S.P. Magnesium Gluconate's compliance with U.S.P. Magnesium Gluconate specifications and serves as a tool for batch-level quality control.

U.S.P. Magnesium Gluconate CoA mostly includes findings from lab analyses of a specific batch. For each U.S.P. Magnesium Gluconate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

U.S.P. Magnesium Gluconate may be tested according to a variety of international standards, such as European Pharmacopoeia (U.S.P. Magnesium Gluconate EP), U.S.P. Magnesium Gluconate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (U.S.P. Magnesium Gluconate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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