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Chemistry

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Also known as: Tripotassium citrate, 866-84-2, Kaliksir, 7778-49-6, Potassium citrate anhydrous, Litocit
Molecular Formula
C6H5K3O7
Molecular Weight
306.39  g/mol
InChI Key
QEEAPRPFLLJWCF-UHFFFAOYSA-K
FDA UNII
86R1NVR0HW

Potassium Citrate
A powder that dissolves in water, which is administered orally, and is used as a diuretic, expectorant, systemic alkalizer, and electrolyte replenisher.
Potassium citrate anhydrous is a Metabolic Alkalinizer. The mechanism of action of potassium citrate anhydrous is as an Alkalinizing Activity.
1 2D Structure

Potassium Citrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
tripotassium;2-hydroxypropane-1,2,3-tricarboxylate
2.1.2 InChI
InChI=1S/C6H8O7.3K/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*+1/p-3
2.1.3 InChI Key
QEEAPRPFLLJWCF-UHFFFAOYSA-K
2.1.4 Canonical SMILES
C(C(=O)[O-])C(CC(=O)[O-])(C(=O)[O-])O.[K+].[K+].[K+]
2.2 Other Identifiers
2.2.1 UNII
86R1NVR0HW
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Anhydrous, Potassium Citrate

2. Citrate, Potassium

3. Potassium Citrate Anhydrous

2.3.2 Depositor-Supplied Synonyms

1. Tripotassium Citrate

2. 866-84-2

3. Kaliksir

4. 7778-49-6

5. Potassium Citrate Anhydrous

6. Litocit

7. Potassiumcitrate

8. Citric Acid, Tripotassium Salt

9. 1,2,3-propanetricarboxylic Acid, 2-hydroxy-, Tripotassium Salt

10. Potassium Citrate Tribasic Solution

11. Tripotassium;2-hydroxypropane-1,2,3-tricarboxylate

12. 86r1nvr0hw

13. Chebi:64733

14. Tripotassium 2-hydroxypropane-1,2,3-tricarboxylate

15. Kalii Citras

16. Porekal

17. Kajos

18. Polycitra K

19. Urocit K

20. Seltz-k

21. K Citrate

22. Potassium Tribasic Citrate

23. Ins No.332(ii)

24. Ins-332(ii)

25. Tripotassium Citrate Anhydrous

26. Acalka

27. Ccris 6566

28. E-332(ii)

29. Hsdb 1248

30. Nsc-760107

31. Einecs 212-755-5

32. Unii-86r1nvr0hw

33. Potassium Citrate (anhydrous)

34. Einecs 231-905-0

35. Tri Potassium Citrate

36. Potassium Citrate (anh.)

37. Anhydrous Potassium Citrate

38. Ec 212-755-5

39. Tripotassium Citrate (anh.)

40. Anhydrous Tripotassium Citrate

41. Potassium Citrate [mi]

42. Chembl1200458

43. Dtxsid8027325

44. Tripotassium Citrate (anhydrous)

45. Potassium Citrate [who-dd]

46. Citric Acid Tripotassium Salt (anh.)

47. Akos015918285

48. Db09125

49. Citric Acid Tripotassium Salt (anhydrous)

50. E332

51. Potassium Citrate Anhydrous [hsdb]

52. Potassium Citrate Anhydrous [mart.]

53. Ft-0653076

54. Potassium 2-hydroxypropane-1,2,3-tricarboxylate

55. A841790

56. Q419921

57. Tripotassium 2-oxidanylpropane-1,2,3-tricarboxylate

58. 1,2,3-propanetricarboxylic Acid, 2-hydroxy-, Potassium Salt (1:?)

59. 1,2,3-propanetricarboxylic Acid, 2-hydroxy-, Potassium Salt (1:3)

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 306.39 g/mol
Molecular Formula C6H5K3O7
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count7
Rotatable Bond Count2
Exact Mass305.8946469 g/mol
Monoisotopic Mass305.8946469 g/mol
Topological Polar Surface Area141 Ų
Heavy Atom Count16
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 Count4
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NamePotassium citrate
PubMed HealthPotassium Citrate (By mouth)
Drug ClassesPotassium Supplement, Urinary Alkalinizer, Urinary Stone Agent
Drug LabelPotassium citrate USP is a citrate salt of potassium and has the chemical name 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tripotassium salt, monohydrate. Its molecular formula is K3C6H 5O7.H2O , and its structural formula is: M.W. 324.41Potassium c...
Active IngredientPotassium citrate
Dosage FormTablet, extended release
RouteOral
Strength5meq; 15meq; 10meq
Market StatusPrescription
CompanyCorepharma; Zydus Pharms Usa

2 of 4  
Drug NameUrocit-k
PubMed HealthPotassium Citrate (By mouth)
Drug ClassesPotassium Supplement, Urinary Alkalinizer, Urinary Stone Agent
Drug LabelUrocit-K is a citrate salt of potassium. Its empirical formula is K3C6H5O7 H2O, and it has the following chemical structure:Urocit-K yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassi...
Active IngredientPotassium citrate
Dosage FormTablet, extended release
RouteOral
Strength5meq; 15meq; 10meq
Market StatusPrescription
CompanyMission Pharma

3 of 4  
Drug NamePotassium citrate
PubMed HealthPotassium Citrate (By mouth)
Drug ClassesPotassium Supplement, Urinary Alkalinizer, Urinary Stone Agent
Drug LabelPotassium citrate USP is a citrate salt of potassium and has the chemical name 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tripotassium salt, monohydrate. Its molecular formula is K3C6H 5O7.H2O , and its structural formula is: M.W. 324.41Potassium c...
Active IngredientPotassium citrate
Dosage FormTablet, extended release
RouteOral
Strength5meq; 15meq; 10meq
Market StatusPrescription
CompanyCorepharma; Zydus Pharms Usa

4 of 4  
Drug NameUrocit-k
PubMed HealthPotassium Citrate (By mouth)
Drug ClassesPotassium Supplement, Urinary Alkalinizer, Urinary Stone Agent
Drug LabelUrocit-K is a citrate salt of potassium. Its empirical formula is K3C6H5O7 H2O, and it has the following chemical structure:Urocit-K yellowish to tan, oral wax-matrix tablets, contain 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassi...
Active IngredientPotassium citrate
Dosage FormTablet, extended release
RouteOral
Strength5meq; 15meq; 10meq
Market StatusPrescription
CompanyMission Pharma

4.2 Therapeutic Uses

Diuretics; Expectorants

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


THE...CITRATE...OF POTASSIUM.../IS/ ADMIN ORALLY. ... 40 MEQ OF POTASSIUM IS PROVIDED BY APPROX...4.3 G OF POTASSIUM CITRATE.

American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 40:12


A SYSTEMIC & URINARY ALKALIZER & FOR THE EFFECTS OF THE POTASSIUM ION. IT HAS ALSO BEEN USED AS AN EXPECTORANT & A DIURETIC. DOSE- USUAL, 1 G. ...USED IN DOSE OF 1-2 G EVERY FEW HR, DILUTED WITH AT LEAST 1/2 GLASSFUL OF WATER OR FRUIT JUICE.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 801


COMPOSITION CONTAINS POTASSIUM CITRATE.

GAGIU F; PREPN FOR TREATMENT OF URIC LITHIASIS; ROMANIAN PATENT NUMBER 57645 09/12/74


MEDICATION (VET): DIURETIC AGENT

The Merck Index. 9th ed. Rahway, New Jersey: Merck & Co., Inc., 1976., p. 990


4.3 Drug Indication

For the management of renal tubular acidosis, hypocitraturic calcium oxalate nephrolithiasis, and uric acid lithiasis with or without calcium stones.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Potassium citrate induces changes in the urine which renders urine less susceptible to the formation of crystals and stones from salts e.g. calcium oxalate, calcium phosphate and uric acid. Increased citrate levels in the urine will make complexation with calcium which decrease the calcium ion activity and decrease the chance for the formation of calcium phosphate crystals. Citrate also inhibits the spontaneous nucleation of calcium oxalate and calcium phosphate.


5.2 MeSH Pharmacological Classification

Diuretics

Agents that promote the excretion of urine through their effects on kidney function. (See all compounds classified as Diuretics.)


Expectorants

Agents that increase mucous excretion. Mucolytic agents, that is drugs that liquefy mucous secretions, are also included here. (See all compounds classified as Expectorants.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
POTASSIUM CITRATE ANHYDROUS
5.3.2 FDA UNII
86R1NVR0HW
5.3.3 Pharmacological Classes
Anti-coagulant [EPC]; Calcium Chelating Activity [MoA]; Calculi Dissolution Agent [EPC]; Decreased Coagulation Factor Activity [PE]; Acidifying Activity [MoA]
5.4 ATC Code

A - Alimentary tract and metabolism

A12 - Mineral supplements

A12B - Potassium

A12BA - Potassium

A12BA02 - Potassium citrate


5.5 Absorption, Distribution and Excretion

Route of Elimination

Urinary; less than 5% unchanged.


5.6 Metabolism/Metabolites

Potassium Citrate is absorbed and the citrate is metabolised to bicarbonate.


5.7 Mechanism of Action

After oral administration of potassium citrate, its metabolism yields alkaline load. Potassium Citrate therapy appears to increase urinary citrate mainly by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate. In addition to raising urinary pH and citrate, Potassium Citrate increases urinary potassium by approximately the amount contained in the medication. In some patients, Potassium Citrate causes a transient reduction in urinary calcium.


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05-Jan-2021
28-Jan-2025
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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10ME...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MEQ

USFDA APPLICATION NUMBER - 19071

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15ME...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MEQ

USFDA APPLICATION NUMBER - 19071

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MEQ

USFDA APPLICATION NUMBER - 19071

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

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

API | Excipient name

Potassium Citrate

Synonyms

Tripotassium citrate, 866-84-2, Kaliksir, 7778-49-6, Potassium citrate anhydrous, Litocit

Cas Number

866-84-2

Unique Ingredient Identifier (UNII)

86R1NVR0HW

About Potassium Citrate

A powder that dissolves in water, which is administered orally, and is used as a diuretic, expectorant, systemic alkalizer, and electrolyte replenisher.

Litocit Manufacturers

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

Litocit Suppliers

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

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

Litocit USDMF

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

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

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

Litocit 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 Litocit Drug Master File in Japan (Litocit JDMF) empowers Litocit 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 Litocit JDMF during the approval evaluation for pharmaceutical products. At the time of Litocit 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 Litocit suppliers with JDMF on PharmaCompass.

Litocit CEP

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

A Litocit CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Litocit 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 Litocit suppliers with CEP (COS) on PharmaCompass.

Litocit WC

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

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

Litocit 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 Litocit as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Litocit GMP

Litocit 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 Litocit 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 Litocit GMP manufacturer or Litocit GMP API supplier for your needs.

Litocit CoA

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

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

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