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Chemistry

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Also known as: 7558-80-7, Sodium dihydrogen phosphate, Sodium phosphate monobasic, Sodium dihydrogenorthophosphate, Sodium acid phosphate, Sodium primary phosphate
Molecular Formula
H2NaO4P
Molecular Weight
119.977  g/mol
InChI Key
AJPJDKMHJJGVTQ-UHFFFAOYSA-M
FDA UNII
KH7I04HPUU

Monosodium Phosphate
Sodium phosphate is a saline laxative that is thought to work by increasing fluid in the small intestine. It usually results in a bowel movement after 30 minutes to 6 hours.
1 2D Structure

Monosodium Phosphate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;dihydrogen phosphate
2.1.2 InChI
InChI=1S/Na.H3O4P/c;1-5(2,3)4/h;(H3,1,2,3,4)/q+1;/p-1
2.1.3 InChI Key
AJPJDKMHJJGVTQ-UHFFFAOYSA-M
2.1.4 Canonical SMILES
OP(=O)(O)[O-].[Na+]
2.2 Other Identifiers
2.2.1 UNII
KH7I04HPUU
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Dibasic Sodium Phosphate, Anhydrous

2. Disodium Acid Phosphate

3. Disodium Hydrogen Phosphate

4. Disodium Hydrogen Phosphate Anhydrous

5. Monosodium Dihydrogen Phosphate

6. Neutral Sodium Hydrogen Phosphate

7. Phosphoric Acid, Disodium Salt

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

9. Phosphoric Acid, Disodium Salt, Anhydrous

10. Phosphoric Acid, Disodium Salt, Dodecahydrate

11. Phosphoric Acid, Disodium Salt, Heptahydrate

12. Phosphoric Acid, Monosodium Salt

13. Phosphoric Acid, Monosodium Salt, Anhydrous

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

15. Phosphoric Acid, Sodium Salt

16. Phosphoric Acid, Trisodium Salt

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

18. Phosphoric Acid, Trisodium Salt , Dodecahydrate

19. Sodium Biphosphate

20. Sodium Dihydrogen Orthophosphate

21. Sodium Dihydrogen Phosphate

22. Sodium Hydrophosphate

23. Sodium Phosphate

24. Sodium Phosphate Monobasic Anhydrous

25. Sodium Phosphate, Dibasic

26. Sodium Phosphate, Dibasic (anhydrous)

27. Sodium Phosphate, Disodium Salt

28. Sodium Phosphate, Monobasic

29. Sodium Phosphate, Monobasic Anhydrous

30. Sodium Phosphate, Tribasic

31. Sodium Phosphate, Tribasic, Dodecahydrate

32. Trisodium Phosphate

33. Trisodium Phosphate Dodecahydrate

2.3.2 Depositor-Supplied Synonyms

1. 7558-80-7

2. Sodium Dihydrogen Phosphate

3. Sodium Phosphate Monobasic

4. Sodium Dihydrogenorthophosphate

5. Sodium Acid Phosphate

6. Sodium Primary Phosphate

7. Monosodium Dihydrogen Orthophosphate

8. Monosodium Monophosphate

9. Sodium Dihydrogenphosphate

10. Monosodium Phosphate, Anhydrous

11. Sodium Phosphate Monobasic Anhydrous

12. Monobasic Sodium Phosphate

13. Acid Sodium Phosphate

14. Monosodium Orthophosphate

15. Sodium Dihydrogen Orthophosphate

16. Monosodium Dihydrogen Phosphate

17. Sodium Dihydrogen Phosphate, Anhydrous

18. Sodium Phosphate (na(h2po4))

19. Sodium;dihydrogen Phosphate

20. Sodium Biphosphate, Anhydrous

21. Sodium Orthophosphate Monobasic

22. Nah2po4

23. Sodium Phosphate,monobasic

24. Kh7i04hpuu

25. Sodium Phosphate, Monobasic Anhydrous

26. Ins No.339(i)

27. Chebi:37585

28. Sodium Phosphate, Monobasic, Anhydrous

29. Monosodium Dihydrogen Monophosphate

30. Ins-339(i)

31. Mfcd00003527

32. Sodium Phosphate Monobasic (anhydrate)

33. Sodium Phosphate Monobasic (anhydrous)

34. 89140-32-9

35. E-339(i)

36. Phosphoric Acid, Monosodium Salt, Anhydrous

37. Monosorb Xp-4

38. Phosphoric Acid, Sodium Salt

39. Primary Sodium Phosphate

40. Mfcd00146206

41. Sodium Biphosphate Anhydrous

42. Monosodium Hydrogen Phosphate

43. Sodium Phosphate (nah2po4)

44. Sodium Orthophosphate, Primary

45. Sodium Dihydrogen Monophosphate

46. Hsdb 738

47. Einecs 231-449-2

48. Unii-kh7i04hpuu

49. Sodium Dihydrogen Phosphate (1:2:1)

50. Sodium Monobasic Phosphate (nah2po4)

51. Sodium Dihydrogen Phosphate (nah2po4)

52. Phosphosoda

53. Buromin

54. Clicolon

55. Armite

56. Instant Calgon

57. Sodiumdihydrogenphosphate-16o4

58. Turrixin St

59. Hy-phos

60. Hemisodium Phosphate

61. Sodium Phosphate Monobasic, Anhydrous

62. Sodium Phosphate Glass

63. Sodiumdihydrogenphosphate

64. Sodium Dihydrogenphoshate

65. Sodium Dihydrogenphospate

66. Sodium Dihydrogenphosphat

67. Sodiumdihydrogen Phosphate

68. Natriumdihydrogen-phosphate

69. Sodium Dihydrogen-phosphate

70. Sodium Phosphate Mono-basic

71. Ec 231-449-2

72. Unii-se337svy37

73. Sodium Salt Of Phosphoric Acid

74. Inkp 100

75. Inkp-100

76. Se337svy37

77. Dtxsid7035222

78. Sodium Phosphate Monobasic Solution

79. Sodium Phosphate, Monobasic (usp)

80. Anhydrous Monobasic Sodium Phosphate

81. Einecs 231-558-5

82. Sodium Dihydrogenphosphate (granular)

83. Phosphoric Acid, Sodium Salt (1:?)

84. Phosphoric Acid, Sodium Salt (1:1)

85. Akos024433265

86. At32901

87. Db09449

88. Sodium Phosphate Monobasic [hsdb]

89. Sodium Phosphate Monobasic, Ar, >=98%

90. Sodium Phosphate Monobasic, Lr, >=97%

91. Sodium Phosphate, Monobasic [mi]

92. E339

93. Sodium Phosphate,monobasic [vandf]

94. Phosphate, 0.2m Buffer Solution, Ph 4.4

95. Phosphate, 0.2m Buffer Solution, Ph 6.8

96. Phosphate, 0.2m Buffer Solution, Ph 7.0

97. Phosphate, 0.2m Buffer Solution, Ph 7.2

98. Phosphate, 0.2m Buffer Solution, Ph 7.4

99. Phosphate, 0.2m Buffer Solution, Ph 7.5

100. Phosphate, 0.2m Buffer Solution, Ph 7.6

101. Phosphate, 0.5m Buffer Solution, Ph 6.5

102. Phosphate, 0.5m Buffer Solution, Ph 7.0

103. Phosphate, 0.5m Buffer Solution, Ph 7.2

104. Phosphate, 0.5m Buffer Solution, Ph 7.4

105. Phosphate, 0.5m Buffer Solution, Ph 8.0

106. Phosphate, 0.5m Buffer Solution, Ph 8.5

107. Phosphate, 0.5m Buffer Solution, Ph 9.0

108. B7779

109. Ft-0698935

110. Sodium Phosphate Monobasic, For Hplc, 99%

111. D04400

112. Sodium Phosphate Monobasic, Bioxtra, >=99.0%

113. Q415877

114. Sodium Phosphate Monobasic, Usp, 98.0-103.0%

115. Sodium Phosphate, 0.2m Buffer Solution, Ph 7.0

116. Sodium Phosphate, 0.2m Buffer Solution, Ph 7.2

117. Sodium Phosphate, 0.2m Buffer Solution, Ph 7.4

118. Sodium Phosphate, 0.2m Buffer Solution, Ph 7.5

119. Sodium Phosphate, 0.2m Buffer Solution, Ph 7.6

120. Sodium Phosphate, 0.2m Buffer Solution, Ph 8.0

121. Sodium Phosphate, 0.2m Buffer Solution, Ph 8.5

122. Sodium Phosphate, 0.2m Buffer Solution, Ph 9.0

123. Sodium Phosphate, 0.2m Buffer Solution, Ph 9.5

124. Sodium Phosphate, 0.5m Buffer Solution, Ph 7.0

125. Sodium Phosphate, 0.5m Buffer Solution, Ph 7.5

126. Sodium Phosphate, 0.5m Buffer Solution, Ph 7.6

127. Sodium Phosphate, 0.5m Buffer Solution, Ph 8.0

128. Sodium Phosphate, 0.5m Buffer Solution, Ph 8.5

129. Sodium Phosphate, 0.5m Buffer Solution, Ph 9.0

130. Sodium Phosphate, 0.5m Buffer Solution, Ph 9.5

131. Sodium Phosphate, Monobasic, Anhydrous [ii]

132. 2-methyl-3-(pyridin-4-ylmethyl)quinazolin-4(3h)-one

133. Sodium Phosphate Monobasic, Reagentplus(r), >=99.0%

134. Sodium Phosphate Monobasic (anhydrous) [who-dd]

135. Sodium Phosphate Monobasic, 99.999% Trace Metals Basis

136. Sodium Phosphate Monobasic Solution, Bioultra, 5 M In H2o

137. Sodium Phosphate Monobasic, Vetec(tm) Reagent Grade, 99%

138. Sodium Phosphate, Monobasic Anhydrous [orange Book]

139. Sodium Phosphate, Monobasic, Anhydrous [orange Book]

140. Sodium Phosphate Monobasic, Saj First Grade, 98.0-101.0%

141. Sodium Phosphate Monobasic, Saj Special Grade, 99.0-101.0%

142. Sodium Phosphate Monobasic, Purum P.a., Anhydrous, >=99.0% (t)

143. Sodium Phosphate Monobasic, Meets Usp Testing Specifications, Anhydrous

144. Sodium Phosphate Monobasic, Anhydrous, Free-flowing, Redi-dri(tm), >=99.0%

145. Sodium Phosphate Monobasic, Bioreagent, For Molecular Biology, Anhydrous, >=98%

146. Sodium Phosphate Monobasic, Biotechnology Performance Certified, Cell Culture Tested

147. Sodium Phosphate Monobasic Molecular Biology Grade, Suitable For Cell Culture, Insect Cell Culture, And Plant Cell Culture

148. Sodium Phosphate Monobasic, Bioperformance Certified, Suitable For Cell Culture, Suitable For Insect Cell Culture, Suitable For Plant Cell Culture, >=99.0% (titration)

2.4 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 119.977 g/mol
Molecular Formula H2NaO4P
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count0
Exact Mass119.95883982 g/mol
Monoisotopic Mass119.95883982 g/mol
Topological Polar Surface Area80.6 Ų
Heavy Atom Count6
Formal Charge0
Complexity61.9
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Therapeutic Uses

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; sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous/

NIH; DailyMed. Current Medication Information for VISICOL (sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous) tablet (December, 2010). Available from, as of October 3, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57ccd52e-5b13-4b39-8aa0-ebecc49a7db4


To determine whether phosphate supplementation, started soon after birth in adequate quantity, would prevent rickets in very low birth weight infants with prenatal deficiency of phosphate, 40 neonates were given an initial dose of 50 mg/day of phosphate administered as a mixture of 189 g of sodium phosphate dibasic (disodium hydrogen phosphate) and 82 g of sodium phosphate monobasic (sodium dihydrogen phosphate) made up to 2 liters with single strength chloroform water or placebo (single strength chloroform water). Supplementation was increased to 37.5 mg every 12 hr if the plasma phosphate concentration remained less than 1.5 mmol/L after one wk. Results showed that no infant receiving phosphate supplements had radiological evidence of rickets whereas bone changes were apparent in 42% of the control group. It was concluded that prenatal deficiency of phosphate, due to placental insufficiency, can be corrected by phosphate supplementation, thereby preventing rickets of prematurity.

PMID:1969066 Holland PC et al; Lancet 335: 697-701 (1990)


The objective of this study was to determine the safety and efficacy of 0.15 mmol/kg phosphorus (PHOS), administered intravenously as sodium or potassium phosphate over 120 minutes, in the treatment of adults suffering from severe hypophosphatemia. Severe hypophosphatemia was defined as a serum PHOS concentration of /LE/ 1.5 mg/dL. Exclusion criteria were renal impairment and hypercalcemia. Patient assessments included mental status, heart rate, and blood pressure. The timing of post-infusion serum PHOS sampling was at physician discretion. Six men and four women were enrolled in the study. During the study period, the only parenteral PHOS administered was the study dose. There were no patient adverse events associated with PHOS administration. One patient who received potassium phosphates had an elevated post-infusion serum potassium (5.2 mEq). Serum PHOS increased above the study criteria for severe hypophosphatemia in all ten patients, although nine patients received concomitant oral PHOS supplements. The dosing of intravenous sodium or potassium phosphate in the treatment of patients with severe hypophosphatemia is empiric. Historical evidence of toxicity has caused dosing recommendations to be low and slow. These data demonstrate the safety of a moderate PHOS dose when administered over two hours to adults, as measured by patient mental status, vital signs, and blood chemistry analysis.

Rice TL, Alaniz C; ASHP Midyear Clinical Meeting 26: PCR-13 (1991)


Sixty patients were randomly divided into three groups of 20 each. Each group was submitted to a bowel preparation with one of the following solutions: 10% manitol, sodium picosulfate or sodium phosphate. The parameters evaluated were: taste, tolerance, associated side effects and quality of cleansing. Postural blood pressure and pulse rate as well as serum sodium, potassium, calcium and phosphate were compared. ... Sodium phosphate and 10% manitol solutions provided superior results in terms of colon cleansing compared to sodium picosulfate solution...

PMID:18516457 Miki P Jr et al; Acta Cir Bras 23 (Supp 1): 108-11 (2008)


For more Therapeutic Uses (Complete) data for SODIUM DIHYDROGEN PHOSPHATE (9 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]).

NIH; DailyMed. Current Medication Information for VISICOL (sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous) tablet (December, 2010). Available from, as of October 3, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57ccd52e-5b13-4b39-8aa0-ebecc49a7db4


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. /Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous/

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, as of January 28, 2014: https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126084.htm


Sodium phosphate and 10% mannitol solutions provided superior results in terms of colon cleansing compared to sodium picosulfate solution. All serum electrolytes evaluated were significantly altered in the three groups, without important clinical signs. High levels of serum phosphate were the most striking alteration in patients prepared with sodium phosphate solution, again with no clinical signs. Variations related to blood pressure and pulse rate suggested contraction of intravascular volume, with no clinical effects.

PMID:18516457 Miki P Jr et al; Acta Cir Bras 23 (Supp 1): 108-11 (2008)


Fifteen male subjects received 50 mL of commerical laxative containing 24 g of sodium biphosphate (sodium phosphate monobasic) and 6 g of sodium phosphate (sodium phosphate dibasic; I) (7 g of elemental phosphorus) administered with 500 mL of water and 11 patients received 300 mL of magnesium citrate (II) containing 3.2 g of elemental magnesium. Patients ranged in age from 26 to 86 yr. Serum magnesium, calcium, phosphorus, total protein, and albumin were determined before and at various intervals up to 16 hr after administration of the laxative and prior to radiological study. The administration of I in conventional doses to normal subjects prior to barium enema resulted in a striking increase in serum phosphorus levels followed by a decline in serum calcium levels in all subjects. Changes were highly significant when compared with control subjects who were prepared for the same procedure with II. Levels of serum potassium also decreased significantly but not serum sodium, chloride, bicarbonate, or magnesium. It would seem wise to caution against the use of phosphate containing laxatives in the presence of severe renal insufficiency, hypocalcemia, or convulsive disorders. In patients who are receiving frequent, repetitive dosages because of difficulty in cleansing the bowel for radiological procedures, serum calcium should be closely monitored. /Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous/

PMID:666471 Wiberg JJ et al; Arch Intern Med 138: 1114-6 (1978)


For more Drug Warnings (Complete) data for SODIUM DIHYDROGEN PHOSPHATE (39 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.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

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


5.2 Absorption, Distribution and Excretion

Absorption

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


... Phosphates are slowly and incompletely absorbed ... . /Dibasic and monobasic sodium phosphate/

Gosselin, R.E., R.P. Smith, H.C. Hodge. Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams and Wilkins, 1984., p. II-120


Intravenously infused phosphorus not taken up by the tissues is excreted almost entirely in the urine. Plasma phosphorus is believed to be filterable by the renal glomeruli, and the major portion of filtered phosphorus (greater than 80%) is actively reabsorbed by the tubules. Many modifying influences tend to alter the amount excreted in the urine.

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


An open-label pharmacokinetic study of Visicol in healthy volunteers was performed to determine the concentration-time profile of serum inorganic phosphorus levels after Visicol administration. All subjects received a total of 60 grams of sodium phosphate with a total liquid volume of 3.6 quarts. Subjects received a 30 gram dose (20 tablets given as 3 tablets every 15 minutes with 8 ounces of clear liquids) beginning at 6 PM and then received a second 30 gram dose (20 tablets given as 3 tablets every 15 minutes with 8 ounces of clear liquids) the following morning beginning at 6 AM. Twenty-three healthy subjects (mean age 57 years old; 57% male and 43% female; and 65% Hispanic, 30% Caucasian, and 4% African-American) participated in this pharmacokinetic study. The serum phosphorus level rose from a mean (+/- standard deviation) baseline of 4.0 (+/- 0.7) mg/dL to 7.7 (+/- 1.6 mg/dL), at a median of 3 hours after the administration of the first 30 gram dose of Visicol tablets The serum phosphorus level rose to a mean of 8.4 (+/- 1.9) mg/dL, at a median of 4 hours after the administration of the second 30 gram dose of Visicol tablets. The serum phosphorus level remained above baseline for a median of 24 hours after the administration of the initial dose of Visicol tablets (range 16 to 48 hours).

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


5.3 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.


... /Promotes/ defecation by retaining water in the intestinal lumen through osmotic forces. ... May also act by stimulating release of cholecystokinin. /Sodium phosphate & sodium biphosphate (Fleet's enema & Fleet's Phospho-soda)/

Miller, R. R., and D. J. Greenblatt. Handbook of Drug Therapy. New York: Elsevier North Holland, 1979., p. 1055


Phosphorus in the form of organic and inorganic phosphate has a variety of important biochemical functions in the body and is involved in many significant metabolic and enzyme reactions in almost all organs and tissues. It exerts a modifying influence on the steady state of calcium levels, a buffering effect on acid-base equilibrium and a primary role in the renal excretion of hydrogen ion.

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


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BIO Partnering at JPM
Not Confirmed

03

BIO Partnering at JPM
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2023-12-20

Pay. Date : 2023-11-24

DMF Number : 38074

Submission : 2023-04-13

Status : Active

Type : II

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04

Sd Fine Chem Ltd

India

USDMF

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BIO Partnering at JPM
Not Confirmed

04

BIO Partnering at JPM
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 28856

Submission : 2014-11-20

Status : Active

Type : IV

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JDMF

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01

BIO Partnering at JPM
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BIO Partnering at JPM
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Japanese Pharmacopoeia Non-Drug Standard Dipotassium Phosphate (For manufacturing only)

Registration Number : 221MF10233

Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Higashi-Koraibashi 1-16

Initial Date of Registration : 2009-10-26

Latest Date of Registration : 2016-09-02

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API Reference Price

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[{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1657218600,"product":"MONOSODIUM PHOSPHATE DIHYDRATE","address":"15, LALWANI INDUSTRIAL ESTATE, 14, G D AMBEKAR ROAD, WADALA,","city":"MUMBAI. MAHARASHTRA","supplier":"VIRBAC","supplierCountry":"URUGUAY","foreign_port":"NA","customer":"CRESCENT LABS PVT ","customerCountry":"INDIA","quantity":"21.00","actualQuantity":"21","unit":"KGS","unitRateFc":"4.6","totalValueFC":"237.3","currency":"USD","unitRateINR":"898.5","date":"08-Jul-2022","totalValueINR":"18869.41","totalValueInUsd":"237.3","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"9462605","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"URUGAY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"15, LALWANI INDUSTRIAL ESTATE, 14, G D AMBEKAR ROAD, WADALA,"}]
08-Jul-2022
08-Jul-2022
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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ABOUT THIS PAGE

Monosodium Phosphate Manufacturers

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

Monosodium Phosphate Suppliers

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

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

Monosodium Phosphate USDMF

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

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

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

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

Monosodium Phosphate 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 Monosodium Phosphate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Monosodium Phosphate GMP

Monosodium Phosphate 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 Monosodium Phosphate 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 Monosodium Phosphate GMP manufacturer or Monosodium Phosphate GMP API supplier for your needs.

Monosodium Phosphate CoA

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

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

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