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    Chemistry

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    Also known as: 7558-79-4, Disodium phosphate, Sodium phosphate dibasic, Disodium hydrogenorthophosphate, Dibasic sodium phosphate, Acetest
    Molecular Formula
    HNa2O4P
    Molecular Weight
    141.959  g/mol
    InChI Key
    BNIILDVGGAEEIG-UHFFFAOYSA-L
    FDA UNII
    22ADO53M6F
    Disodium Hydrogen Phosphate
    1 2D Structure

    Disodium Hydrogen Phosphate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    disodium;hydrogen phosphate
    2.1.2 InChI
    InChI=1S/2Na.H3O4P/c;;1-5(2,3)4/h;;(H3,1,2,3,4)/q2*+1;/p-2
    2.1.3 InChI Key
    BNIILDVGGAEEIG-UHFFFAOYSA-L
    2.1.4 Canonical SMILES
    OP(=O)([O-])[O-].[Na+].[Na+]
    2.2 Other Identifiers
    2.2.1 UNII
    22ADO53M6F
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Dibasic Sodium Phosphate, Anhydrous

    2. Disodium Acid Phosphate

    3. Disodium Hydrogen Phosphate Anhydrous

    4. Monosodium Dihydrogen Phosphate

    5. Neutral Sodium Hydrogen Phosphate

    6. Phosphoric Acid, Disodium Salt

    7. Phosphoric Acid, Disodium Salt, 32p-labeled

    8. Phosphoric Acid, Disodium Salt, Anhydrous

    9. Phosphoric Acid, Disodium Salt, Dodecahydrate

    10. Phosphoric Acid, Disodium Salt, Heptahydrate

    11. Phosphoric Acid, Monosodium Salt

    12. Phosphoric Acid, Monosodium Salt, Anhydrous

    13. Phosphoric Acid, Sodium (2:3) Salt

    14. Phosphoric Acid, Sodium Salt

    15. Phosphoric Acid, Trisodium Salt

    16. Phosphoric Acid, Trisodium Salt , 32p-labeled

    17. Phosphoric Acid, Trisodium Salt , Dodecahydrate

    18. Sodium Biphosphate

    19. Sodium Dihydrogen Orthophosphate

    20. Sodium Dihydrogen Phosphate

    21. Sodium Hydrophosphate

    22. Sodium Phosphate

    23. Sodium Phosphate Monobasic Anhydrous

    24. Sodium Phosphate, Dibasic

    25. Sodium Phosphate, Dibasic (anhydrous)

    26. Sodium Phosphate, Disodium Salt

    27. Sodium Phosphate, Monobasic

    28. Sodium Phosphate, Monobasic Anhydrous

    29. Sodium Phosphate, Tribasic

    30. Sodium Phosphate, Tribasic, Dodecahydrate

    31. Trisodium Phosphate

    32. Trisodium Phosphate Dodecahydrate

    2.3.2 Depositor-Supplied Synonyms

    1. 7558-79-4

    2. Disodium Phosphate

    3. Sodium Phosphate Dibasic

    4. Disodium Hydrogenorthophosphate

    5. Dibasic Sodium Phosphate

    6. Acetest

    7. Sodium Phosphate, Dibasic

    8. Disodium Acid Phosphate

    9. Disodium Hydrogenphosphate

    10. Soda Phosphate

    11. Phosphoric Acid, Disodium Salt

    12. Exsiccated Sodium Phosphate

    13. Disodium Orthophosphate

    14. Sodium Hydrogenphosphate

    15. Sodium Hydrogen Phosphate

    16. Sodium Monohydrogen Phosphate

    17. Fema No. 2398

    18. Secondary Sodium Phosphate

    19. Disodium;hydrogen Phosphate

    20. Disodium Acid Orthophosphate

    21. Sec-sodium Phosphate

    22. Disodium Phosphate, Anhydrous

    23. Disodium Monohydrogen Phosphate

    24. Disodium Hydrogen Phosphate, Anhydrous

    25. Hydrogen Disodium Phosphate

    26. Sodium Phosphate, Dibasic, Anhydrous

    27. Sodium Phosphate, Dibasic (anhydrous)

    28. Sodium Phosphate, Dibasic Anhydrous

    29. Sodium Phosphate Dibasic Anhydrous

    30. Na2hpo4

    31. Phosphoric Acid, Sodium Salt (1:2)

    32. Disodium Hydrogen Monophosphate

    33. 22ado53m6f

    34. Disodium Hydrogen Orthophosphate

    35. Ins No.339(ii)

    36. Dsp

    37. Chebi:34683

    38. Ins-339(ii)

    39. Dibasic Sodium Phosphate Anhydrous

    40. Dibasic Sodium Phosphate, Anhydrous

    41. E-339(ii)

    42. Mfcd00003496

    43. Phosphoric Acid, Disodium Salt, Anhydrous

    44. Phosphate Of Soda

    45. Monohydrogen Sodium Phosphate

    46. Caswell No. 778

    47. Disodium Hydrophosphate

    48. Fema Number 2398

    49. Fleet Enema

    50. Natriumphosphat [german]

    51. Sodium Phosphate (nahpo4)

    52. Sodium Phosphate, Exsiccated

    53. Ccris 5931

    54. Hsdb 376

    55. Sodium Orthophosphate, Secondary

    56. Sodium Acid Phosphate, Anhydrous

    57. Einecs 231-448-7

    58. Potassium Phosphate Monobasic/sodium Phosphate Dibasic

    59. Epa Pesticide Chemical Code 076403

    60. Sodium Monohydrogen Phosphate (2:1:1)

    61. Unii-22ado53m6f

    62. Disodium Phospahte

    63. Sodiumphosphatedibasic

    64. Disodiumhydrogenphosphate

    65. Sodium Hydrogen-phosphate

    66. Disodium Hydrogen-phosphate

    67. Buffer Salt, Ph 6.87

    68. Buffer Salt, Ph 7.42

    69. Ec 231-448-7

    70. Sorensen's Sodium Phosphate

    71. Di-sodium Hydrogen Phosphate

    72. Phosphoric Acid Disodium Salt

    73. Sodium Hydrogen Orthophosphate

    74. Sodium Phosphate, Unspecified

    75. Sodium Phosphate [fhfi]

    76. Dtxsid1026039

    77. Disodium Phosphate [hsdb]

    78. Disodium Phosphate [inci]

    79. Sodium Phosphate,dibasic,anhydrous

    80. Bcp13559

    81. Sodium Hydrogen Phosphate, Anhydrous

    82. Sodium Phosphate Dibasic, Acs Grade

    83. Disodium Hydrogen Phosphate Submicron

    84. Disodium Phosphate (fragrance Grade)

    85. Akos015902440

    86. Akos015950661

    87. Disodium Phosphate (industrial Grade)

    88. Ccg-266159

    89. Db14502

    90. Sodium Phosphate, Dibasic [mi]

    91. Disodium Phosphate [ep Monograph]

    92. Sodium Phosphate Dibasic [who-dd]

    93. Sodium Phosphate Dibasic, Biochemical Grade

    94. B7293

    95. Ft-0625321

    96. Sodium Phosphate Dibasic, Trace Metals Grade

    97. A937532

    98. Q418448

    99. Sodium Phosphate, Dibasic, Anhydrous [ii]

    100. Sodium Phosphate,dibasic,anhydrous [vandf]

    101. Phosphoric-32p Acid,disodium Salt (8ci,9ci)

    102. Disodium Hydrogen Orthophosphate;sodium Hydrogen Phosphate

    103. Sodium Phosphate, Dibasic Anhydrous [orange Book]

    104. Sodium Phosphate, Dibasic, Anhydrous [orange Book]

    105. Visicol Component Sodium Phosphate, Dibasic Anhydrous

    106. Osmoprep Component Sodium Phosphate, Dibasic Anhydrous

    107. Sodium Phosphate, Dibasic Anhydrous Component Of Visicol

    108. Sodium Phosphate, Dibasic Anhydrous Component Of Osmoprep

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 141.959 g/mol
    Molecular Formula HNa2O4P
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count0
    Exact Mass141.94078407 g/mol
    Monoisotopic Mass141.94078407 g/mol
    Topological Polar Surface Area83.4 Ų
    Heavy Atom Count7
    Formal Charge0
    Complexity46.5
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    Cathartics

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

    Sodium Phosphates Injection, USP, ... is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for Sodium Phosphates (Sodium Phosphate) Injection (June 2006). Available from, as of March 20, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=1758

    Visicol tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for VISICOL (sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous) tablet (November 2008). Available from, as of March 20, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=1758

    Although sodium and/or potassium phosphates have been used in the treatment of hypercalcemia, USP medical advisory panels do not recommend this use since these medications have been replaced by safer and more effective agents. /Phosphates/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2453

    For more Therapeutic Uses (Complete) data for DISODIUM HYDROGEN PHOSPHATE (14 total), please visit the HSDB record page.

    4.2 Drug Warning

    /BOXED WARNING/ There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long-term dialysis. While some cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and possibly nonsteroidal anti-inflammatory drugs (NSAIDs)).

    US Natl Inst Health; DailyMed. Current Medication Information for Osmoprep (sodium phosphate, monobasic, monohydrate, sodium phosphate, dibasic anhydrous) tablet (Updated: March 2013). Available from, as of April 24, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b46c0b17-c49b-4791-913f-3e6e1fdbe88e

    FDA has become aware of reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products (OSP) for bowel cleansing prior to colonoscopy or other procedures. These products include the prescription products, Visicol and OsmoPrep, and OSPs available over-the-counter without a prescription as laxatives (e.g., Fleet Phospho-soda). In some cases when used for bowel cleansing, these serious adverse events have occurred in patients without identifiable factors that would put them at risk for developing acute kidney injury. We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSPs or they did not drink sufficient fluids after ingesting OSP. Acute phosphate nephropathy is a form of acute kidney injury that is associated with deposits of calcium-phosphate crystals in the renal tubules that may result in permanent renal function impairment. Acute phosphate nephropathy is a rare, serious adverse event that has been associated with the use of OSPs. The occurrence of these events was previously described in an Information for Healthcare Professionals sheet and an FDA Science Paper issued in May 2006. Additional cases of acute phosphate nephropathy have been reported to FDA and described in the literature since these were issued. Individuals who appear to have an increased risk of acute phosphate nephropathy following the use of OSPs include persons: who are over age 55; who are hypovolemic or have decreased intravascular volume; who have baseline kidney disease, bowel obstruction, or active colitis; and who are using medications that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]). As a result of new safety information received, FDA is requiring the manufacturer of Visicol and OsmoPrep, the two OSPs available by prescription only, to add a Boxed Warning to the labeling for these products. FDA is also requiring that the manufacturer develop and implement a risk evaluation and mitigation strategy (REMS), which will include a Medication Guide, to ensure that the benefits of these products outweigh the risk of acute phosphate nephropathy, and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with use of these products.

    FDA/CDER; FDA Alert: Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription) (12/11/2008). Available from: https://www.fda.gov/cder/drug/infopage/OSP_solution/default.htm as of March 20,2009.

    This phosphate should not be confused with tribasic sodium phosphate which is very alkaline and has caustic action.

    Osol, A. (ed.). Remington's Pharmaceutical Sciences. 16th ed. Easton, Pennsylvania: Mack Publishing Co., 1980., p. 745

    Oral administration is safer, but careful monitoring of serum electrolyte levels and renal function is necessary. Nausea, vomiting, and diarrhea may occur and may be dose dependent. Concomitant use of antacids containing aluminum and/or magnesium should be avoided, because they may bind phosphate and prevent it absorption (calcium antacids also may bind phosphate, and it is assumed that these agents are not given to hypercalcemic patients). /Monobasic or dibasic sodium or potassium phosphate/

    American Medical Association, Department of Drugs. Drug Evaluations. 6th ed. Chicago, Ill: American Medical Association, 1986., p. 897

    For more Drug Warnings (Complete) data for DISODIUM HYDROGEN PHOSPHATE (57 total), please visit the HSDB record page.

    4.3 Minimum/Potential Fatal Human Dose

    The estimated fatal dose of sodium phosphates is 50 g.

    Dreisbach, R.H. Handbook of Poisoning. 12th ed. Norwalk, CT: Appleton and Lange, 1987., p. 212

    4.4 Drug Indication

    Used to treat constipation or to clean the bowel before a colonoscopy.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Sodium phosphate inceases fecal water content to increase mobility through the large intestine.

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Increased Large Intestinal Motility [PE]
    5.3 Absorption, Distribution and Excretion

    Absorption

    Tmax for phosphate absorption with orally administered liquid sodium phosphate is 1-3h.

    ... Phosphates (dibasic and monobasic sodium phosphate) are slowly and incompletely absorbed. /Dibasic and Monobasic Sodium phosphate/

    Gosselin, R.E., H.C. Hodge, R.P. Smith, and M.N. Gleason. Clinical Toxicology of Commercial Products. 4th ed. Baltimore: Williams and Wilkins, 1976., p. II-83

    Net phosphorus absorption may occur in the small intestine in some species but is primarily a function of the colon in horses. /Phosphorus/

    Booth, N.H., L.E. McDonald (eds.). Veterinary Pharmacology and Therapeutics. 5th ed. Ames, Iowa: Iowa State University Press, 1982., p. 640

    Elimination: Renal (90%) and fecal (10%). /Phosphates/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2453

    Ingested phosphates are absorbed from the gastrointestinal tract. However, the presence of large amounts of calcium or aluminum may lead to formation of insoluble phosphate and reduce the net absorption. Vitamin D stimulates phosphate absorption. /Phosphates/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2453

    For more Absorption, Distribution and Excretion (Complete) data for DISODIUM HYDROGEN PHOSPHATE (9 total), please visit the HSDB record page.

    5.4 Mechanism of Action

    Sodium phosphate is thought to work by increasing the amount of solute present in the intestinal lumen thereby creating an osmotic gradient which draws water into the lumen.

    At the renal distal tubule, the secretion of hydrogen by the tubular cell in exchange for sodium in the tubular urine converts dibasic phosphate salts to monobasic phosphate salts. Therefore, large amounts of acid can be excreted without lowering the pH of the urine to a degree that would block hydrogen transport by a high concentration gradient between the tubular cell and luminal fluid. /Phosphates/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2453

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    ACS DOBFAR SPA

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    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    ACS DOBFAR SPA

    Italy

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10195

    Submission : 1993-04-13

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    Quality Chemicals

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Antibody Engineering
    Not Confirmed
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    Quality Chemicals

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Antibody Engineering
    Not Confirmed
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-233 - Rev 02

    Issue Date : 2023-10-23

    Type : Chemical

    Substance Number : 118

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SOLUTION;IRRIGATION - 0.154MG/ML;0.9...DOSAGE - SOLUTION;IRRIGATION - 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML

    USFDA APPLICATION NUMBER - 18469

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    DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML...DOSAGE - INJECTABLE;INJECTION - 3.68GM/1000ML;3.05GM/1000ML;0.314GM/1000ML ;3.09GM/1000ML;6.34GM/1000ML;0.187GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 207026

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    DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;3....DOSAGE - INJECTABLE;INJECTION - N/A/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;6.95GM/1000ML;0.187GM/1000ML (5000ML)

    USFDA APPLICATION NUMBER - 207026

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