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Chemistry

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Also known as: 33725-54-1, Iron (iii) maltol, Ferric maltol [inn], Ferric maltol [usan], St10, Ma10qyf1z0
Molecular Formula
C18H15FeO9
Molecular Weight
431.2  g/mol
InChI Key
AHPWLYJHTFAWKI-UHFFFAOYSA-K
FDA UNII
MA10QYF1Z0

Ferric Maltol
Ferric maltol is an iron(III) atom complexed with 3 maltol molecules to increase the bioavailability compared to iron(II), without depositing it in the duodenum as insoluble ferric hydroxide and phosphate. Ferric maltol has been described in literature since at least the late 1980s as a potential treatment for iron deficiency. Ferric maltol was granted FDA Approval on 25 July 2019.
1 2D Structure

Ferric Maltol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
iron(3+);2-methyl-4-oxopyran-3-olate
2.1.2 InChI
InChI=1S/3C6H6O3.Fe/c3*1-4-6(8)5(7)2-3-9-4;/h3*2-3,8H,1H3;/q;;;+3/p-3
2.1.3 InChI Key
AHPWLYJHTFAWKI-UHFFFAOYSA-K
2.1.4 Canonical SMILES
CC1=C(C(=O)C=CO1)[O-].CC1=C(C(=O)C=CO1)[O-].CC1=C(C(=O)C=CO1)[O-].[Fe+3]
2.2 Other Identifiers
2.2.1 UNII
MA10QYF1Z0
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Accrufer

2. Iron (iii) Maltol

3. Iron(3+) Tris(2-methyl-4-oxo-4h-pyran-3-olate)

2.3.2 Depositor-Supplied Synonyms

1. 33725-54-1

2. Iron (iii) Maltol

3. Ferric Maltol [inn]

4. Ferric Maltol [usan]

5. St10

6. Ma10qyf1z0

7. Iron(3+);2-methyl-4-oxopyran-3-olate

8. Iron(iii) 2-methyl-4-oxo-4h-pyran-3-olate

9. St10-021

10. Iron Maltol

11. Feraccru (tn)

12. Unii-ma10qyf1z0

13. Ferric Maltol [mi]

14. Ferric Maltol (usan/inn)

15. Ferric Maltol [usan:inn]

16. Ferric Maltol [who-dd]

17. St-10

18. Ferric Maltol [orange Book]

19. Who 9974

20. Db15598

21. Iron(iii)2-methyl-4-oxo-4h-pyran-3-olate

22. D10833

23. E83926

24. Q27283748

25. Iron, Tris(3-hydroxy-2-methyl-4h-pyran-4-onato-o3,o4)-

26. Iron, Tris(3-(hydroxy-.kappa.o)-2-methyl-4h-pyran-4-onato-.kappa.o4)-

27. Tris(3-(hydroxy-.kappa.o)-2-methyl-4h-pyran-4-onato-.kappa.o4)iron(iii)

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 431.2 g/mol
Molecular Formula C18H15FeO9
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count9
Rotatable Bond Count0
Exact Mass431.006543 g/mol
Monoisotopic Mass431.006543 g/mol
Topological Polar Surface Area148 Ų
Heavy Atom Count28
Formal Charge0
Complexity200
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count4
4 Drug and Medication Information
4.1 Drug Indication

Ferric maltol is indicated to treat iron deficiency in adults.


Feraccru is indicated in adults for the treatment of iron deficiency.


Treatment of iron deficiency


5 Pharmacology and Biochemistry
5.1 Pharmacology

Ferric maltol is used to provide supplemental iron to patients with an iron deficiency. It has a wide therapeutic index as patients generally take 30mg twice daily, while concentrations of 20mg/kg may produce toxicity. Patients should be counselled regarding the risk of inflammatory bowel disease flares, iron overload, and accidental ingestion in children.


5.2 MeSH Pharmacological Classification

Hematinics

Agents which improve the quality of the blood, increasing the hemoglobin level and the number of erythrocytes. They are used in the treatment of anemias. (See all compounds classified as Hematinics.)


5.3 FDA Pharmacological Classification
5.3.1 Pharmacological Classes
Parenteral Iron Replacement [EPC]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]; Iron [CS]
5.4 ATC Code

B03AB


B - Blood and blood forming organs

B03 - Antianemic preparations

B03A - Iron preparations

B03AB - Iron trivalent, oral preparations

B03AB10 - Ferric maltol


5.5 Absorption, Distribution and Excretion

Absorption

Ferric maltol dissociates in the gastrointestinal tract, leading to a Tmax of 1.5-3.0 hours for iron concentrations. Mean serum iron increases by 146mol/L in iron deficient patients following a single dose. a 60mg dose is approximately 14% bioavailable. 60 minutes after injection of radiolabelled ferric maltol, 11+2% of the dose is present in the bone marrow, 181% is present in the liver, and 2.61% is in the urine. Maltol has an AUC of 0.022-0.205h\*g/mL and maltol glucuronide has an AUC of 9.83-30.9h\*g/mL.


Route of Elimination

39.8-60% of an oral dose of ferric maltol is excreted in the urine as a glucuronide conjugate. Iron and ferric maltol are not excreted in the urine and unabsorbed ferric maltol is eliminated in the feces.


Volume of Distribution

Data regarding the volume of distribution of ferric maltol is not readily available.


Clearance

Data regarding the clearance of ferric maltol is not readily available.


5.6 Metabolism/Metabolites

_In vitro_, ferric maltol metabolism is predominantly glucuronidation of maltol by UGT1A6 and sulfation.


5.7 Biological Half-Life

Maltol has a half life of 0.7h.


5.8 Mechanism of Action

Ferric maltol dissociates as the iron atom is donated to unknown iron uptake mechanisms, possibly beta 3 integrin or divalent metal transporter 1, in the ileum and duodenum. Once the iron is in circulation, it then associates with transferrin and ferritin.


API Reference Price

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15-Feb-2021
10-Dec-2024
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ABOUT THIS PAGE

Looking for 33725-54-1 / Ferric Maltol API manufacturers, exporters & distributors?

Ferric Maltol manufacturers, exporters & distributors 1

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

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ferric Maltol manufacturer or Ferric Maltol supplier.

PharmaCompass also assists you with knowing the Ferric Maltol API Price utilized in the formulation of products. Ferric Maltol API Price is not always fixed or binding as the Ferric Maltol Price is obtained through a variety of data sources. The Ferric Maltol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Ferric Maltol

Synonyms

33725-54-1, Iron (iii) maltol, Ferric maltol [inn], Ferric maltol [usan], St10, Ma10qyf1z0

Cas Number

33725-54-1

Unique Ingredient Identifier (UNII)

MA10QYF1Z0

About Ferric Maltol

Ferric maltol is an iron(III) atom complexed with 3 maltol molecules to increase the bioavailability compared to iron(II), without depositing it in the duodenum as insoluble ferric hydroxide and phosphate. Ferric maltol has been described in literature since at least the late 1980s as a potential treatment for iron deficiency. Ferric maltol was granted FDA Approval on 25 July 2019.

Ferric Maltol Manufacturers

A Ferric Maltol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferric Maltol, including repackagers and relabelers. The FDA regulates Ferric Maltol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferric Maltol 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 Ferric Maltol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ferric Maltol Suppliers

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

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

Ferric Maltol 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 Ferric Maltol as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ferric Maltol 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 Ferric Maltol 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 Ferric Maltol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ferric Maltol NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Ferric Maltol suppliers with NDC on PharmaCompass.

Ferric Maltol GMP

Ferric Maltol 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 Ferric Maltol 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 Ferric Maltol GMP manufacturer or Ferric Maltol GMP API supplier for your needs.

Ferric Maltol CoA

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

Ferric Maltol CoA mostly includes findings from lab analyses of a specific batch. For each Ferric Maltol 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.

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