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    Chemistry

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    Also known as: Iron(iii) citrate, Iron citrate, 3522-50-7, Zerenex, 6043-74-9, 28633-45-6
    Molecular Formula
    C6H5FeO7
    Molecular Weight
    244.94  g/mol
    InChI Key
    NPFOYSMITVOQOS-UHFFFAOYSA-K
    FDA UNII
    63G354M39Z
    Ferric Citrate
    1 2D Structure

    Ferric Citrate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-hydroxypropane-1,2,3-tricarboxylate;iron(3+)
    2.1.2 InChI
    InChI=1S/C6H8O7.Fe/c7-3(8)1-6(13,5(11)12)2-4(9)10;/h13H,1-2H2,(H,7,8)(H,9,10)(H,11,12);/q;+3/p-3
    2.1.3 InChI Key
    NPFOYSMITVOQOS-UHFFFAOYSA-K
    2.1.4 Canonical SMILES
    C(C(=O)[O-])C(CC(=O)[O-])(C(=O)[O-])O.[Fe+3]
    2.2 Other Identifiers
    2.2.1 UNII
    63G354M39Z
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Ferric Citrate Anhydrous

    2. Ferric Citrate Dihydrate

    3. Ferric Citrate Hydrate

    4. Ferric Citrate Iron(+3) Salt

    5. Ferric Citrate Trihydrate

    6. Ferric Citrate, 59fe-labeled Cpd

    7. Ferric Citrate, Iron Salt, 59fe-labeled Cpd

    8. Ferric-citric Acid

    9. Iron(iii) Citrate

    10. Jtt-751

    11. Zerenex

    2.3.2 Depositor-Supplied Synonyms

    1. Iron(iii) Citrate

    2. Iron Citrate

    3. 3522-50-7

    4. Zerenex

    5. 6043-74-9

    6. 28633-45-6

    7. Citric Acid, Iron(3+) Salt

    8. Ferrum Citricum

    9. Ferriccitrate

    10. Iron(iii) Citrate Tribasic

    11. 1,2,3-propanetricarboxylic Acid, 2-hydroxy-, Iron(3+) Salt (1:1)

    12. Ferric Citrate Anhydrous

    13. Krx-0502

    14. Iron(iii)citrate

    15. Iron Citrate, Fec6h5o7

    16. Auryxia

    17. Iron(3+) Citrate

    18. 63g354m39z

    19. 2338-05-8

    20. Iron, (hydrogen Citrato(3-))-

    21. Citric Acid, Iron(3+) Salt (1:1)

    22. Ferrous Citrate

    23. Iron(iii) 2-hydroxypropane-1,2,3-tricarboxylate

    24. 2-hydroxy-1,2,3-propanetricarboxylic Acid Iron Salt

    25. Ferric Citrate [usan]

    26. Ferric Citrate Tetrahydrate

    27. Jtt-751

    28. Ferric Citrate (van)

    29. 2-hydroxypropane-1,2,3-tricarboxylate;iron(3+)

    30. Nsc-112227

    31. Fexeric

    32. Iron(3+) 2-hydroxypropane-1,2,3-tricarboxylate

    33. Unii-63g354m39z

    34. Jtt 751

    35. Fe(iii)-citrate Complex (1:1)

    36. Einecs 222-536-6

    37. Einecs 249-117-0

    38. Iron(iii)-citrate

    39. Iron (iii) Citrate

    40. Nsc 112227

    41. Citric Acid, Iron Salt

    42. 1185-57-5

    43. Citric Acid,iron(3+)salt

    44. Ferric Citrate [mi]

    45. Schembl42945

    46. Ferric Citrate [fcc]

    47. 2-hydroxypropane-1,2,3-tricarboxylate; Iron(3+)

    48. Ferric Citrate [inci]

    49. Ferrum Citricum [hpus]

    50. Ccris 6843

    51. Dtxsid0037657

    52. Ferric Citrate [who-dd]

    53. Iron(iii) Citrate;iron Citrate

    54. Hy-n1428c

    55. 1,2,3-propanetricarboxylic Acid, 2-hydroxy-, Iron(3+) Salt

    56. Bcp30645

    57. Ferric Citrate [orange Book]

    58. Akos015918266

    59. Db09162

    60. Db-119245

    61. Cs-0030977

    62. Ft-0626407

    63. Ft-0627304

    64. Ft-0652224

    65. Iron 2-hydroxy-1,2,3-propanetricarboxylate

    66. A832727

    67. Iron(3+); 2-oxidanylpropane-1,2,3-tricarboxylate

    68. Q15628111

    69. 1,2,3-propanetricarboxylic Acid, 2-hydroxy-, Iron Salt (1:?)

    70. 1,2,3-propanetricarboxylic Acid, 2-hydroxy-, Iron(2+) Salt (2:3)

    2.4 Create Date
    2005-07-19
    3 Chemical and Physical Properties
    Molecular Weight 244.94 g/mol
    Molecular Formula C6H5FeO7
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count2
    Exact Mass244.938463 g/mol
    Monoisotopic Mass244.938463 g/mol
    Topological Polar Surface Area141 Ų
    Heavy Atom Count14
    Formal Charge0
    Complexity211
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameFerric citrate
    PubMed HealthFerric Citrate (Oral route)
    Drug ClassesPhosphate Binder
    Drug LabelFerric Citrate is known chemically as iron (+3), x (1, 2, 3-propanetricarboxylic acid, 2 hydroxy-), y (H2O)Ferric Citrate 210 mg ferric iron tablets, equivalent to 1g ferric citrate, are film-coated, peach-colored, and oval-shaped tablets embossed wi...
    Active IngredientFerric citrate
    Dosage FormTablet
    RouteOral
    Strength210mg
    Market StatusPrescription
    CompanyKeryx Biopharma

    2 of 2  
    Drug NameFerric citrate
    PubMed HealthFerric Citrate (Oral route)
    Drug ClassesPhosphate Binder
    Drug LabelFerric Citrate is known chemically as iron (+3), x (1, 2, 3-propanetricarboxylic acid, 2 hydroxy-), y (H2O)Ferric Citrate 210 mg ferric iron tablets, equivalent to 1g ferric citrate, are film-coated, peach-colored, and oval-shaped tablets embossed wi...
    Active IngredientFerric citrate
    Dosage FormTablet
    RouteOral
    Strength210mg
    Market StatusPrescription
    CompanyKeryx Biopharma

    4.2 Therapeutic Uses

    Source of iron in treating iron-deficiency anemias. It is less constipating than inorg forms of iron. It is free from astringent & irritant properties. However, ferric ion is less well absorbed than ferrous ion, so that its supposed advantages are outweighed by its lesser efficacy, and it is considered to be an obsolete preparation. In the forms presently marketed, a unit dose provides only the recommended daily allowance of iron (15 mg). /former use/

    Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 777

    VET: Used in prevention & treatment of anemias. Oral biololgy availabilities in rats and chicks have been reported as 107 and 115% respectively, compared to ferrous sulfate. Counteracts oral poisonous effects of gossypol (in cottonseed meal) in poultry trials. Used in wide variety of oral and parenteral hematinics.

    Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 216

    Hematinic

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 90

    VET: In iron deficiency anemia.

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 90

    For more Therapeutic Uses (Complete) data for FERRIC AMMONIUM CITRATE (6 total), please visit the HSDB record page.

    Hematinic

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 716

    The in vitro and in vivo availability of iron from total parenteral nutrition solutions to which ferrous citrate has been added was investigated. In vitro experiments showed that 74% of the added iron was available to transferrin. In 7 patients in whom in vivo availability was tested by red cell incorporation, the mean availability was 81%. It was concluded that ferrous citrate is a safe and effective means of iron supplementation in patients on TPN therapy.

    Sayers MH et al. JPEN J Parenter Enteral Nutr 7 (2): 117-20 (1983)

    4.3 Drug Indication

    Fexeric is indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD).

    5 Pharmacology and Biochemistry
    5.1 FDA Pharmacological Classification
    5.1.1 Pharmacological Classes
    Parenteral Iron Replacement [EPC]; Phosphate Binder [EPC]; Phosphate Chelating Activity [MoA]; Iron [CS]
    5.2 ATC Code

    V03AE

    V - Various

    V03 - All other therapeutic products

    V03A - All other therapeutic products

    V03AE - Drugs for treatment of hyperkalemia and hyperphosphatemia

    V03AE08 - Ferric citrate

    5.3 Absorption, Distribution and Excretion

    The absorption and endogenous excretion of iron in man was studied by monitoring the fecal excretion of a stable iron isotope (58Fe). The study was carried out for 12 healthy volunteers who were divided into two groups. Group I received 58Fe-labeled ferric ammonium citrate (III) (58FeAC) equivalent to 6 mg of iron as a control, and group II received a combination of 500 mg of vitamin C and 58FeAC. A new formula was used to calculate the 58Fe absorption ratio reflecting the pool of iron in the intestinal cells, and the ratio was compared with that obtained from Janghorbani's formula, which has been used as one of the common methods. As a result, the 58Fe absorption ratio in group II was statistically significantly higher than that of group I (34.4 +/- 6.1% vs. 15.0 +/- 5.5%, M +/- SD) using Janghorbani's formula. The similar absorption ratio (34.1 +/- 6.0% vs. 14.8 +/- 5.5%) was also obtained by our new formula. Our results confirmed the previous findings that the availability of iron is stimulated by the supplementation of vitamin C. Both formulae agreed in the absorption of iron, indicating that the endogenous excretion of iron (caused by the desquamated cells) in the intestine does not disguise the iron absorption.

    PMID:1294703 Hashimoto F et al; J Nutr Sci Vitaminol (Tokyo) 38 (5): 435-49 (1992)

    The absorption of a commercial brand of small-particle reduced iron was evaluated in 10 normal subjects. For each subject, the hemoglobin incorporation method was used to measure the true absorption of 60 mg of iron from either ferrous sulfate or ferric ammonium citrate. The iron tolerance test (ITT) was also studied for these two compounds and for reduced iron. This procedure consisted of measuring the area under the curve of plasma iron elevations at specified times for 6 hours, or the peak plasma iron, corrected by the plasma iron disappearance rate obtained from measuring plasma iron at specified times for 4 hours after the slow intravenous injection of 0.4 mg of iron as ferric citrate. Only the ITT was used to measure the absorption of 60 mg of reduced iron. Reference dose iron ascorbate absorption was measured in each subject. The absorption of ferric ammonium citrate and reduced iron was expressed as percent of dose and also as absorption percent of that of ferrous sulfate. Mean % geometric "true absorptions" were 39.0 for reference dose, 10.4 for FeSO4 and 2.4 for ferric ammonium citrate. The later was 23% that of FeSO4. By ITT the mean geometric % absorptions were 7.9, 3.7 and 3.2 for FeSO4, ferric ammonium citrate and reduced iron respectively, or 47 and 41% of that of FeSO4. We propose that the true absorption of the commercial brand of reduced iron tested was 20% that of FeSO4 based on the relation between the ITT results of reduced iron and the ITT and true absorption values of ferric ammonium citrate in relation to FeSO4.

    PMID:11791474 Gonzalez H et al; Arch Latinoam Nutr 51 (3): 217-24 (2001)

    Gastrointestinal absorption of iron is adequate ... /yet/ ... lower from ferrous citrate ... /than ferrous sulfate, fumarate, gluconate, succinate, glutamate, and lactate/.

    Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1315

    This study demonstrated that anticholinergic agents decreased iron absorption in man and animals. Six normal males were given 10 Ci of 59Fe ferrous citrate dissolved in water containing 250 mg of ferrous sulfate after an overnight fast. Whole body counts were done 4 hours later and used as baseline studies. Sixty minutes before the administration of radioiron, the subjects received a dose of 62.5 mg of hexocyclium methosulfate (Tral). The dose was repeated 6 hours later. Four hours after ingestion of radioiron, whole body counting was done. Every 5 days thereafter, for 15 days, a plateau of body radioactivity was reached in all subjects. Percentage absorption was calculated from the final to initial counts, after correction. Similar experiments were done in rats with atropine sulfate. In both experiments, the anticholinergic agent produced a decrease in iron absorption. The effect of atropine persisted when the iron was delivered intragastrically, but not intraduodenally. Another set of experiments showed that iron absorption decreases when radioiron is intraduodenally given in deproteinized acid gastric juice, or in 0.1N HCl, but not when mixed with neutralized gastric juice.

    Orrego-Matte H et al; Am J Dige Dis 16 (9): 789-795 (1971)

    The uptake of ferrous citrate 59Fe was studied in pregnant rats with or without a 4-dimethylamino-stilben(DS)-induced sarcoma tumor. ... The embryo showed higher concentrations of 59Fe. ... Iron loading only affected the embryo liver. Tumors and the placenta showed a different incorporation of 59Fe.

    PMID:3857177 Anghileri LJ et al; Eur J Nucl Med 10 (5-6): 288-9 (1985)

    5.4 Mechanism of Action

    ... Iron loading by 24-hour incubation with 0.36 mmol/L ferric ammonium citrate resulted in a decrease in the activity of nicotinamide adenine dinucleotide (NADH)-cytochrome c oxidoreductase (complex I+III) to 35.3%+/-11.2% of the value in untreated controls; of succinate-cytochrome c oxidoreductase (complex II+III) to 57.4%+/-3.1%; and of succinate dehydrogenase to 63.5%+/-12.6% (p < 0.001 in all cases). The decrease in activity of other mitochondrial enzymes, including NADH-ferricyanide reductase, succinate ubiquinone oxidoreductase (complex II), cytochrome c oxidase (complex IV), and ubiquinol cytochrome c oxidoreductase (complex III), was less impressive and ranged from 71.5%+/-15.8% to 91.5%+/-14.6% of controls. That the observed loss of respiratory enzyme activity was a specific effect of iron toxicity was clearly demonstrated by the complete restoration of enzyme activities by in vitro iron chelation therapy. Sequential treatment with iron and doxorubicin caused a loss of complex I+III and complex II+III activity that was greater than that seen with either agent alone but was only partially correctable by DF treatment. Alterations in cellular adenosine triphosphate measurements paralleled very closely the changes observed in respiratory complex activity.

    PMID:9605112 Link G et al; J Lab Clin Med 131 (5): 466-74 (1998)

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    07-Mar-2023
    03-May-2025
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    ABOUT THIS PAGE

    Looking for 23383-11-1 / Ferric Citrate API manufacturers, exporters & distributors?

    Ferric Citrate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Ferric Citrate 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 Citrate manufacturer or Ferric Citrate supplier for your needs.

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

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

    API | Excipient name

    Ferric Citrate

    Synonyms

    Iron(iii) citrate, Iron citrate, 3522-50-7, Zerenex, 6043-74-9, 28633-45-6

    Cas Number

    23383-11-1

    Unique Ingredient Identifier (UNII)

    63G354M39Z

    Ferric Citrate Manufacturers

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

    Ferric Citrate Suppliers

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

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

    Ferric Citrate USDMF

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

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

    click here to find a list of Ferric Citrate suppliers with USDMF on PharmaCompass.

    Ferric Citrate JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Ferric Citrate Drug Master File in Japan (Ferric Citrate JDMF) empowers Ferric Citrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Ferric Citrate JDMF during the approval evaluation for pharmaceutical products. At the time of Ferric Citrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Ferric Citrate suppliers with JDMF on PharmaCompass.

    Ferric Citrate WC

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

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

    Ferric Citrate GMP

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

    Ferric Citrate CoA

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

    Ferric Citrate CoA mostly includes findings from lab analyses of a specific batch. For each Ferric Citrate 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 Citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ferric Citrate EP), Ferric Citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ferric Citrate 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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