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1. Ferric Citrate
2. Ferric Citrate Anhydrous
3. Ferric Citrate Dihydrate
4. Ferric Citrate Hydrate
5. Ferric Citrate Iron(+3) Salt
6. Ferric Citrate Trihydrate
7. Ferric Citrate, 59fe-labeled Cpd
8. Ferric Citrate, Iron Salt, 59fe-labeled Cpd
9. Ferric-citric Acid
10. Iron(iii) Citrate
11. Jtt-751
12. Zerenex
1. Tetraferric Tricitrate Decahydrate
2. Ferric Citrate Hydrate
3. Ferric Citrate [usan]
4. Krx-0502
5. Db14520
6. Iron (as Ferric Citrate) [vandf]
7. Q91187k011
8. Q22075864
9. 1,2,3-propanetricarboxylic Acid, 2-hydroxy-, Iron(3+) Salt, Hydrate (4:3:10)
| Molecular Weight | 967.8 g/mol |
|---|---|
| Molecular Formula | C18H32Fe4O31 |
| Hydrogen Bond Donor Count | 10 |
| Hydrogen Bond Acceptor Count | 31 |
| Rotatable Bond Count | 6 |
| Exact Mass | 967.83250 g/mol |
| Monoisotopic Mass | 967.83250 g/mol |
| Topological Polar Surface Area | 440 Ų |
| Heavy Atom Count | 53 |
| Formal Charge | 0 |
| Complexity | 211 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 17 |
Tetraferric tricitrate decahydrate is indicated to control serum phosphorous in adults with chronic kidney disease who require dialysis. Tetraferric tricitrate decahydrate is also indicated to treat iron deficiency anemia in adults with chronic kidney disease who are not on dialysis.
Tetraferric tricitrate decahydrate is an iron containing product indicated to treat iron deficiency anemia and hyperphosphatemia. It has a wide therapeutic index, as doses can be varied significantly between patients. Tetraferric tricitrate decahydrate has a long duration of action in the treatment of iron deficiency anemia, due to the slow loss of iron from the body, and a moderate duration of action in the treatment of hyperphosphatemia, due to its action being dependant on residence time in the gastrointestinal tract. Patients should be counselled regarding the risk of iron overload.
Absorption
Ferric iron has been shown to have inferior bioavailability to ferrous iron preparations. Tetraferric tricitrate decahydrate has 19% the bioavailability of ferrous ascorbate.
Route of Elimination
Unabsorbed oral Tetraferric tricitrate decahydrate is eliminated in the feces. The absorbed iron from Tetraferric tricitrate decahydrate is generally not eliminated from the body by any route other than blood loss and exfoliation of epithelial cells.
Clearance
Data regarding the clearance of iron is not readily available. However, iron loss due to exfoliation of epithelial cells is approximately 1mg/day.
Ferric cation is converted to ferrous iron by duodenal cytochrome B reductase. The heavy chain ferritin may also convert ferric iron to ferrous iron
Ferric (Fe3+) iron is absorbed from the gastrointestinal tract by divalent metal transporter-1, and reduced to ferrous (Fe2+) iron by ferrireductase and cytochrome b reductase 1. Ferrous iron is stored intracellularly in ferritin and transported into the blood by ferroportin 1. Transport by ferroportin 1 is coupled with oxidation to ferric iron by hephaestin or ceruloplasmin. Ferric iron in plasma is bound to transferrin, which carries iron to other cells. Iron is transported to mitochondria for the synthesis of heme or iron-sulfur clusters, which are integral parts of several metalloproteins like hemoglobin. Ferric iron can also bind to phosphate in the gastrointestinal tract, which precipitates as the insoluble ferric phosphate. Ferric phosphate remains unabsorbed and is eliminated in the feces. Decreased phosphate absorption gradually lowers phosphate levels in the blood.
ABOUT THIS PAGE
A ferric citrate anhydrous manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ferric citrate anhydrous, including repackagers and relabelers. The FDA regulates ferric citrate anhydrous manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ferric citrate anhydrous API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A ferric citrate anhydrous supplier is an individual or a company that provides ferric citrate anhydrous active pharmaceutical ingredient (API) or ferric citrate anhydrous finished formulations upon request. The ferric citrate anhydrous suppliers may include ferric citrate anhydrous API manufacturers, exporters, distributors and traders.
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 citrate anhydrous as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ferric citrate anhydrous API and other APIs are published in this directory by the FDA.
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 citrate anhydrous 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.
The NDC directory also contains data on finished compounded human drug products that contain ferric citrate anhydrous and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ferric citrate anhydrous NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ferric citrate anhydrous suppliers with NDC on PharmaCompass.
ferric citrate anhydrous 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 anhydrous 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 anhydrous GMP manufacturer or ferric citrate anhydrous GMP API supplier for your needs.
A ferric citrate anhydrous CoA (Certificate of Analysis) is a formal document that attests to ferric citrate anhydrous's compliance with ferric citrate anhydrous specifications and serves as a tool for batch-level quality control.
ferric citrate anhydrous CoA mostly includes findings from lab analyses of a specific batch. For each ferric citrate anhydrous 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 anhydrous may be tested according to a variety of international standards, such as European Pharmacopoeia (ferric citrate anhydrous EP), ferric citrate anhydrous JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ferric citrate anhydrous USP).
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