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    Chemistry

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    Also known as: Magnesiumhydroxide, Magnesium (as hydroxide), Chebi:6637, Ins no.528, 1909-42-8, Oxaine m
    Molecular Formula
    H2MgO2
    Molecular Weight
    58.320  g/mol
    InChI Key
    VTHJTEIRLNZDEV-UHFFFAOYSA-L
    FDA UNII
    NBZ3QY004S
    Magnesium Hydroxide
    An inorganic compound that occurs in nature as the mineral brucite. It acts as an antacid with cathartic effects.
    1 2D Structure

    Magnesium Hydroxide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    magnesium;dihydroxide
    2.1.2 InChI
    InChI=1S/Mg.2H2O/h;2*1H2/q+2;;/p-2
    2.1.3 InChI Key
    VTHJTEIRLNZDEV-UHFFFAOYSA-L
    2.1.4 Canonical SMILES
    [OH-].[OH-].[Mg+2]
    2.2 Other Identifiers
    2.2.1 UNII
    NBZ3QY004S
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Acetamide, 2,2'-((2-hydroxyethyl)imino)bis-(n-(1,1-dimethyl-2-phenylethyl))-n-methyl-, Mixture With Aluminum Hydroxide (al(oh)3) And Magnesium Hydroxide (mg(oh)2)

    2. Acetamide, 2,2'-((2-hydroxyethyl)imino)bis-(n-(1,1-dimethyl-2-phenylethyl))-n-methyl-, Mixture With Aluminum Hydroxide And Magnesium Hydroxide

    3. Oxaine M

    4. Brucite

    5. Hydrate, Magnesium

    6. Hydroxide, Magnesium

    7. Magnesium Hydrate

    8. Magnesium Hydroxide

    9. Magnesium Hydroxide (mg(oh)4)

    2.3.2 Depositor-Supplied Synonyms

    1. Magnesiumhydroxide

    2. Magnesium (as Hydroxide)

    3. Chebi:6637

    4. Ins No.528

    5. 1909-42-8

    6. Oxaine M

    7. Ins-528

    8. E-528

    9. Magnesium Hydrate

    10. Magnesium Hydroxide Suspension

    11. 1317-43-7

    12. Magnesium Hydroxide (gilumag)

    13. Phenol,2-[4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-(2-buten-1-yloxy)-

    14. Magnesium Hydroxide [jan]

    15. Magnesiumhydroxid

    16. Magnesii Hydroxidum

    17. Magnesium-hydroxide

    18. Magnesium(2+) Hydroxide

    19. Magnesium Hydroxide Powder

    20. Mg(oh)2

    21. Chembl1200718

    22. Dtxsid4049662

    23. Magnesium Hydroxide [ii]

    24. Magnesium Hydroxide [mi]

    25. Magnesium Hydroxide [fcc]

    26. Magnesium Hydroxide 100g

    27. Magnesium Hydroxide [hsdb]

    28. Magnesium Hydroxide [inci]

    29. Magnesium Hydroxide [vandf]

    30. Magnesium Hydroxide [mart.]

    31. Magnesium Hydroxide Gilumag D211

    32. Magnesium Hydroxide Gilumag D212

    33. Magnesium Hydroxide Gilumag D213

    34. Magnesium Hydroxide Gilumag D214

    35. Magnesium Hydroxide Gilumag D611

    36. Magnesium Hydroxide Gilumag D661

    37. Magnesium Hydroxide Gilumag D671

    38. Magnesium Hydroxide [usp-rs]

    39. Magnesium Hydroxide [who-dd]

    40. Akos015904092

    41. Db09104

    42. Magnesium Hydroxide [ep Impurity]

    43. Magnesium Hydroxide [orange Book]

    44. E528

    45. Magnesium Hydroxide [ep Monograph]

    46. Magnesii Hydroxidum [who-ip Latin]

    47. Magnesium Hydroxide [usp Monograph]

    48. Ft-0628085

    49. Ft-0693469

    50. C07876

    51. Pharmaceutical Grade Magnesium Hydroxide Hd ~ Usp

    52. Q407548

    53. J-005906

    54. Pepcid Complete Component Magnesium Hydroxide

    55. Magnesium Hydroxide Component Of Pepcid Complete

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 58.320 g/mol
    Molecular Formula H2MgO2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count2
    Rotatable Bond Count0
    Exact Mass57.9905210 g/mol
    Monoisotopic Mass57.9905210 g/mol
    Topological Polar Surface Area2 Ų
    Heavy Atom Count3
    Formal Charge0
    Complexity0
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Indication

    Magnesium hydroxide can be used as an antacid or a laxative depending on the administered dose. As an antacid, it is used for the temporary relief of heartburn, upset stomach, sour stomach or acid indigestion. As a laxative, it is used for the relief of occasional constipation by promoting bowel movements for 30 minutes and up to 6 hours.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    As an antacid, magnesium hydroxide suspension neutralizes gastric acid by reacting with hydrochloric acid in the stomach to form magnesium chloride and water. It is practically insoluble in water and does not have any effect until it reacts with the hydrochloric acid in the stomach. There, it decreases the direct acid irritant effect and increases the pH in the stomach leading to inactivation of pepsin. Magnesium hydroxide enhances the integrity of the mucosal barrier of the stomach as well as improving the tone of both the gastric and esophageal sphincters. As a laxative, the magnesium hydroxide works by increasing the osmotic effect in the intestinal tract and drawing water in. This creates distension of the colon which results in an increase in peristaltic movement and bowel evacuation.

    5.2 MeSH Pharmacological Classification

    Antacids

    Substances that counteract or neutralize acidity of the GASTROINTESTINAL TRACT. (See all compounds classified as Antacids.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]; Calculi Dissolution Agent [EPC]
    5.4 Absorption, Distribution and Excretion

    Absorption

    About 15%-50% of magnesium hydroxide is absorbed very slowly through the small intestine.

    Route of Elimination

    After oral administration, up to 50% of the magnesium hydroxide suspension may be absorbed as magnesium ions through the small intestines and then rapidly excreted in the urine through the kidneys. The unabsorbed drug is mainly excreted in the feces and saliva.

    Volume of Distribution

    The peak action and distribution of magnesium hydroxide are variable.

    Clearance

    Magnesium hydroxide is mainly excreted in the urine by the kidneys. Since the kidneys play a major role in its clearance, individuals with renal failure are at risk of hypermagnesemia with long term consumption as the appropriate amounts of magnesium may not be excreted.

    5.5 Metabolism/Metabolites

    Unless a patient is deficient in magnesium, very little is absorbed by the intestine. Overall, about 15%-50% of the magnesium hydroxide suspension is absorbed systemically. However, it does not undergo any metabolism as it is rapidly excreted in the urine.

    5.6 Biological Half-Life

    N/A

    5.7 Mechanism of Action

    The suspension of magnesium hydroxide is ingested and enters the stomach. According to the amount ingested, the magnesium hydroxide will either act as an antacid or a laxative. Through the ingestion of 0.5-1.5 grams (in adults) the magnesium hydroxide will act by simple acid neutralization in the stomach. The hydroxide ions from the magnesium hydroxide suspension will combine with the acidic H+ ions of the hydrochloric acid made by the stomachs parietal cells. This neutralization reaction will result in the formation of magnesium chloride and water. Through the ingestion of 2-5 grams (in adults) the magnesium hydroxide acts as a laxative in the colon. The majority of the suspension is not absorbed in the intestinal tract and will create an osmotic effect to draw water into the gut from surrounding tissues. With this increase of water in the intestines, the feces will soften and the intraluminal volume of the feces will increase. These effects still stimulate intestinal motility and induce the urge to defecate. Magnesium hydroxide will also release cholecystokinin (CKK) in the intestines which will accumulate water and electrolytes in the lumen and furthermore increase intestinal motility.

    API Reference Price

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    08-Apr-2021
    11-Oct-2023
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    ABOUT THIS PAGE

    Magnesium Hydroxide Manufacturers

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

    click here to find a list of Magnesium Hydroxide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Magnesium Hydroxide Suppliers

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

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

    Magnesium Hydroxide USDMF

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

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

    click here to find a list of Magnesium Hydroxide suppliers with USDMF on PharmaCompass.

    Magnesium Hydroxide KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Magnesium Hydroxide Drug Master File in Korea (Magnesium Hydroxide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Magnesium Hydroxide. The MFDS reviews the Magnesium Hydroxide KDMF as part of the drug registration process and uses the information provided in the Magnesium Hydroxide KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Magnesium Hydroxide KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Magnesium Hydroxide API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Magnesium Hydroxide suppliers with KDMF on PharmaCompass.

    Magnesium Hydroxide CEP

    A Magnesium Hydroxide CEP of the European Pharmacopoeia monograph is often referred to as a Magnesium Hydroxide Certificate of Suitability (COS). The purpose of a Magnesium Hydroxide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Magnesium Hydroxide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Magnesium Hydroxide to their clients by showing that a Magnesium Hydroxide CEP has been issued for it. The manufacturer submits a Magnesium Hydroxide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Magnesium Hydroxide CEP holder for the record. Additionally, the data presented in the Magnesium Hydroxide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Magnesium Hydroxide DMF.

    A Magnesium Hydroxide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Magnesium Hydroxide CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Magnesium Hydroxide suppliers with CEP (COS) on PharmaCompass.

    Magnesium Hydroxide WC

    A Magnesium Hydroxide written confirmation (Magnesium Hydroxide WC) is an official document issued by a regulatory agency to a Magnesium Hydroxide manufacturer, verifying that the manufacturing facility of a Magnesium Hydroxide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Magnesium Hydroxide APIs or Magnesium Hydroxide finished pharmaceutical products to another nation, regulatory agencies frequently require a Magnesium Hydroxide WC (written confirmation) as part of the regulatory process.

    click here to find a list of Magnesium Hydroxide suppliers with Written Confirmation (WC) on PharmaCompass.

    Magnesium Hydroxide NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Magnesium Hydroxide as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Magnesium Hydroxide API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Magnesium Hydroxide as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Magnesium Hydroxide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Magnesium Hydroxide NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Magnesium Hydroxide suppliers with NDC on PharmaCompass.

    Magnesium Hydroxide GMP

    Magnesium Hydroxide 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 Magnesium Hydroxide 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 Magnesium Hydroxide GMP manufacturer or Magnesium Hydroxide GMP API supplier for your needs.

    Magnesium Hydroxide CoA

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

    Magnesium Hydroxide CoA mostly includes findings from lab analyses of a specific batch. For each Magnesium Hydroxide 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.

    Magnesium Hydroxide may be tested according to a variety of international standards, such as European Pharmacopoeia (Magnesium Hydroxide EP), Magnesium Hydroxide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Magnesium Hydroxide 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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