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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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LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"3745.00","actualQuantity":"3745","unit":"KGS","unitRateFc":"10.6","totalValueFC":"40111","currency":"USD","unitRateINR":"894.1","date":"03-Jun-2024","totalValueINR":"3348441.95","totalValueInUsd":"40111","indian_port":"JNPT","hs_no":"29181510","bill_no":"3797518","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HAMBURG","supplierAddress":"AM HAFEN 18 DE-68526 Ladenburg, ,GermanySDNF Germany","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720722600,"product":"POTASSIUM CITRATE USP (TRIPOTASSIUM CITRATE M1201)","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"JUNGBUNZLAUER INTERNATIONAL AG","supplierCountry":"GERMANY","foreign_port":"ROTTERDAM","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"KGS","unitRateFc":"10.6","totalValueFC":"53544.6","currency":"USD","unitRateINR":"895.2","date":"12-Jul-2024","totalValueINR":"4475850","totalValueInUsd":"53544.6","indian_port":"JNPT","hs_no":"29181510","bill_no":"4468500","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"AM HAFEN 18 DE-68526 Ladenburg, ,GermanySDNF Germany","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722018600,"product":"TRI-POTASSIUM CITRATE MONOHYDRATE EMPROVE ESSENTIAL PH EUR,BP,USP,FCC,E 332 4PCS X 5KG (PHARMA GRADE)","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK GROUP","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"6167.5","totalValueFC":"1479.3","currency":"INR","unitRateINR":"6182.9","date":"27-Jul-2024","totalValueINR":"123657.49","totalValueInUsd":"1479.3","indian_port":"Bombay Air","hs_no":"29181590","bill_no":"4733816","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 25064293 Darmstadt Germany (BENEFICIARY MERCKFINANCIAL SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722623400,"product":"TRI-POTASSIUM CITRATE MONOHYDRATE EMPROVE ESSENTIAL PH EUR,BP,USP,FCC,E 332 11PCS X 5KG (PHARMA GRADE)","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK GROUP","customerCountry":"INDIA","quantity":"55.00","actualQuantity":"55","unit":"KGS","unitRateFc":"6167.5","totalValueFC":"4054.2","currency":"INR","unitRateINR":"6182.9","date":"03-Aug-2024","totalValueINR":"340058.11","totalValueInUsd":"4054.2","indian_port":"Bombay Air","hs_no":"29181590","bill_no":"4861687","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 25064293 Darmstadt Germany (BENEFICIARY MERCKFINANCIAL SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723833000,"product":"TRI-POTASSIUM CITRATE MONOHYDRATE EMPROVE ESSENTIAL PH EUR,BP,USP,FCC,E 332 11PCS X 5KG (PHARMA GRADE)","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK GROUP","customerCountry":"INDIA","quantity":"55.00","actualQuantity":"55","unit":"KGS","unitRateFc":"6167.5","totalValueFC":"4054.2","currency":"INR","unitRateINR":"6182.9","date":"17-Aug-2024","totalValueINR":"340058.11","totalValueInUsd":"4054.2","indian_port":"Bombay Air","hs_no":"29181590","bill_no":"5100898","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 25064293 Darmstadt Germany (BENEFICIARY MERCKFINANCIAL SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724610600,"product":"TRI-POTASSIUM CITRATE MONOHYDRATE EMPROVE ESSENTIAL PH EUR,BP,USP,FCC,E 332 4PCS X 5KG (PHARMA GRADE)","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK GROUP","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"6167.5","totalValueFC":"1474.2","currency":"INR","unitRateINR":"6182.9","date":"26-Aug-2024","totalValueINR":"123657.49","totalValueInUsd":"1474.2","indian_port":"Bombay Air","hs_no":"29181590","bill_no":"5251260","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 25064293 Darmstadt Germany (BENEFICIARY MERCKFINANCIAL SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724697000,"product":"TRIPOTASSIUM CITRATE MONOHYDRATE","address":"PLOT NO.26,2ND CROSS,JIGANI","city":"BANGALORE","supplier":"GIVAUDAN INTERNATIONAL SA","supplierCountry":"ISRAEL","foreign_port":"ANTWERPEN","customer":"GIVAUDAN INDIA PRIVATE ","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"5.7","totalValueFC":"571.7","currency":"USD","unitRateINR":"479.6","date":"27-Aug-2024","totalValueINR":"47955.78","totalValueInUsd":"571.7","indian_port":"JNPT","hs_no":"29181590","bill_no":"5272942","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"ANTWERPEN","supplierAddress":"CHEMIN DE LA PARFUMERIE 5CH-1214 VERNIERSDNF SWITZERLAND","customerAddress":"PLOT NO.26,2ND CROSS,JIGANI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"POTASSIUM CITRATE USP (TRIPOTASSIUM CITRATE M1201)","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"JUNGBUNZLAUER INTERNATIONAL AG","supplierCountry":"GERMANY","foreign_port":"ANTWERPEN","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"10.6","totalValueFC":"107164.9","currency":"USD","unitRateINR":"900.5","date":"25-Oct-2024","totalValueINR":"9004700","totalValueInUsd":"107164.9","indian_port":"JNPT","hs_no":"29181510","bill_no":"6318234","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"ANTWERPEN","supplierAddress":"AM HAFEN 18 DE-68526 Ladenburg, , Germany SDNF Germany","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"}]
    18-Jan-2021
    15-Nov-2024
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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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    ABOUT THIS PAGE

    Potassium Citrate Manufacturers

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

    Potassium Citrate Suppliers

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

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

    Potassium Citrate USDMF

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

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

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

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

    Potassium Citrate CEP

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

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

    Potassium Citrate WC

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

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

    Potassium Citrate 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 Potassium Citrate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Potassium Citrate GMP

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

    Potassium Citrate CoA

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

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

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