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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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    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18935

    Submission : 2005-11-02

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    ACS DOBFAR SPA

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10195

    Submission : 1993-04-13

    Status : Inactive

    Type : II

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    ✖

    Certificate Number : CEP 2017-233 - Rev 02

    Issue Date : 2023-10-23

    Type : Chemical

    Substance Number : 118

    Status : Valid

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    Europe

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    FRESENIUS KABI ITALIA Srl

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    Riboflavin; Disodium Hydrogen Phosphate; Niacinamide; Pyridoxine Hydrochloride; Pantothenic Acid; Ascorbic Acid; Biotin; Folic Acid; Vitamin B 12

    Brand Name : Soluvit

    Dosage Form : Thiamin Riboflav+.+Sodium Phosph.+Nicotinam.+Piridoss.+Ac.Pantoten.+Ac.Ascorb.+Biotin+Ac.Folic Cianocobal+.10Ml 10 Units

    Dosage Strength : "AD" 10 VIALS EV 10 ml

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    Disodium Hydrogen Phosphate

    Brand Name : Fleet Phospho-soda

    Dosage Form : Potion, resolution

    Dosage Strength : 10.8 g/dose/24.4 g/dose

    Packaging : Bottle of plastic

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    Disodium Hydrogen Phosphate

    Brand Name : Phospholax

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    Dosage Strength : 10 Bust Soluz Os 20 Ml

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    Disodium Hydrogen Phosphate

    Brand Name : Phospholax

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    Dosage Strength : 2 Bust Soluz Os 20 Ml

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    Disodium Hydrogen Phosphate

    Brand Name : Phospho Soda Fleet

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    Dosage Strength : Os Soluz 45 Ml 48% + 18%_

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    Disodium Hydrogen Phosphate

    Brand Name : Sodium Phosphate

    Dosage Form : Sodium Phosphate Monobasic+Dibasic Sodium Phosphate 16+6% 120Ml 25 Joined The Rectal Use

    Dosage Strength : 25 bottles 120 ml soluz rett

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    Disodium Hydrogen Phosphate

    Brand Name : Phosphoral

    Dosage Form : Potion, resolution

    Dosage Strength : 10.8 g/dose/24.4 g/dose

    Packaging : Bottle of plastic

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    Disodium Hydrogen Phosphate

    Brand Name : Phosphoral

    Dosage Form : Potion, resolution

    Dosage Strength : 10.8 g/dose/24.4 g/dose

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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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    ABOUT THIS PAGE

    Sodium phosphate dibasic Manufacturers

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

    Sodium phosphate dibasic Suppliers

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

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

    Sodium phosphate dibasic USDMF

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

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

    click here to find a list of Sodium phosphate dibasic suppliers with USDMF on PharmaCompass.

    Sodium phosphate dibasic CEP

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

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

    Sodium phosphate dibasic 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 Sodium phosphate dibasic as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Sodium phosphate dibasic suppliers with NDC on PharmaCompass.

    Sodium phosphate dibasic GMP

    Sodium phosphate dibasic 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 Sodium phosphate dibasic 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 Sodium phosphate dibasic GMP manufacturer or Sodium phosphate dibasic GMP API supplier for your needs.

    Sodium phosphate dibasic CoA

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

    Sodium phosphate dibasic CoA mostly includes findings from lab analyses of a specific batch. For each Sodium phosphate dibasic 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.

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