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Ofichem Edetate Calcium Disodium

Synopsis

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8

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2

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5

South Africa

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Chemistry

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Also known as: 139-33-3, Edta disodium salt, Disodium edetate, Edta disodium, Titriplex iii, Disodium edta

Molecular Formula

C₁₀H₁₄N₂Na₂O₈

Molecular Weight

336.21 g/mol

InChI Key

ZGTMUACCHSMWAC-UHFFFAOYSA-L

Edetate Calcium Disodium

A chelating agent that sequesters a variety of polyvalent cations such as CALCIUM. It is used in pharmaceutical manufacturing and as a food additive.

1 2D Structure

Edetate Calcium Disodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

disodium;2-[2-[carboxylatomethyl(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetate

2.1.2 InChI

InChI=1S/C10H16N2O8.2Na/c13-7(14)3-11(4-8(15)16)1-2-12(5-9(17)18)6-10(19)20;;/h1-6H2,(H,13,14)(H,15,16)(H,17,18)(H,19,20);;/q;2*+1/p-2

2.1.3 InChI Key

ZGTMUACCHSMWAC-UHFFFAOYSA-L

2.1.4 Canonical SMILES

C(CN(CC(=O)O)CC(=O)[O-])N(CC(=O)O)CC(=O)[O-].[Na+].[Na+]

2.2 Synonyms

2.2.1 MeSH Synonyms

1. Acid, Edetic

2. Acid, Ethylenediaminetetraacetic

3. Acid, Ethylenedinitrilotetraacetic

4. Calcitetracemate, Disodium

5. Calcium Disodium Edetate

6. Calcium Disodium Versenate

7. Calcium Tetacine

8. Chelaton 3

9. Chromium Edta

10. Copper Edta

11. Coprin

12. Dicobalt Edta

13. Dinitrilotetraacetate, Disodium Ethylene

14. Dinitrilotetraacetate, Ethylene

15. Disodium Calcitetracemate

16. Disodium Edta

17. Disodium Ethylene Dinitrilotetraacetate

18. Disodium Versenate, Calcium

19. Distannous Edta

20. Edathamil

21. Edetate Disodium Calcium

22. Edetate, Calcium Disodium

23. Edetates

24. Edetic Acid

25. Edetic Acid, Calcium Salt

26. Edetic Acid, Calcium, Sodium Salt

27. Edetic Acid, Chromium Salt

28. Edetic Acid, Dipotassium Salt

29. Edetic Acid, Disodium Salt

30. Edetic Acid, Disodium Salt, Dihydrate

31. Edetic Acid, Disodium, Magnesium Salt

32. Edetic Acid, Disodium, Monopotassium Salt

33. Edetic Acid, Magnesium Salt

34. Edetic Acid, Monopotassium Salt

35. Edetic Acid, Monosodium Salt

36. Edetic Acid, Potassium Salt

37. Edetic Acid, Sodium Salt

38. Edta

39. Edta, Chromium

40. Edta, Copper

41. Edta, Dicobalt

42. Edta, Disodium

43. Edta, Distannous

44. Edta, Gallium

45. Edta, Magnesium Disodium

46. Edta, Potassium

47. Edta, Stannous

48. Ethylene Dinitrilotetraacetate

49. Ethylene Dinitrilotetraacetate, Disodium

50. Ethylenediaminetetraacetic Acid

51. Ethylenedinitrilotetraacetic Acid

52. Gallium Edta

53. Magnesium Disodium Edta

54. N,n'-1,2-ethanediylbis(n-(carboxymethyl)glycine)

55. Potassium Edta

56. Stannous Edta

57. Tetacine, Calcium

58. Tetracemate

59. Versenate

60. Versenate, Calcium Disodium

61. Versene

2.2.2 Depositor-Supplied Synonyms

1. 139-33-3

2. Edta Disodium Salt

3. Disodium Edetate

4. Edta Disodium

5. Titriplex Iii

6. Disodium Edta

7. Disodium Edta, Anhydrous

8. Cheladrate

9. Ethylenediaminetetraacetic Acid Disodium Salt

10. Disodium Versene

11. Endrate Disodium

12. Sodium Versenate

13. Disodium Salt Of Edta

14. Metaquest B

15. Kiresuto B

16. Chelaplex Iii

17. Complexon Iii

18. Diso-tate

19. Chelaton Iii

20. Versene Na

21. Triplex Iii

22. Chelaton 3

23. Disodium Versenate

24. Edathamil Disodium

25. Trilon Bd

26. Versene Na2

27. Disodium Sequestrene

28. Disodium Tetracemate

29. F 1 (complexon)

30. Disodium Ethylenediaminetetraacetate

31. Sequestrene Sodium 2

32. Ethylenediaminetetraacetic Acid, Disodium Salt

33. Disodium Edta Dihydrate

34. Perma Kleer Di Crystals

35. Edetic Acid Disodium Salt

36. Disodium Edetate Dihydrate

37. Disodium Dihydrogen Ethylenediaminetetraacetate

38. Disodium Ethylenediamine-n,n,n',n'-tetraacetate

39. Glycine, N,n'-1,2-ethanediylbis[n-(carboxymethyl)-, Disodium Salt

40. Edta-na2

41. Edta Disodium Salt (anhydrous)

42. Edetate Disodium Anhydrous

43. Perma Kleer 50 Crystals Disodium Salt

44. Disodium Ethylenediaminetetraacetic Acid

45. Ethylene Diamine Tetraacetic Acid, Disodium Salt

46. Disodium (ethylenedinitrilo)tetraacetate

47. Sodium Ethylenediaminetetraacetate

48. Cbc 50152966

49. Dr-16133

50. Ethylenediaminetetraacetate, Disodium Salt

51. Disodium Diacid Ethylenediaminetetraacetate

52. Mfcd00070672

53. Disodium (ethylenedinitrilo)tetraacetic Acid

54. Trilon B

55. Disodium Dihydrogen(ethylenedinitrilo)tetraacetate

56. Glycine, N,n'-1,2-ethanediylbis(n-(carboxymethyl)-, Disodium Salt

57. Endrate (tn)

58. Chelest B

59. Komplexon Iii

60. Clewat N

61. Disodium Edathamil

62. Zonon D

63. Dotite 2na

64. Selekton B 2

65. Tetracemate Disodium

66. Mavacid Ed 4

67. Na2-edta

68. Disodium Edetate Hydrate

69. Versonol 120

70. Chelest 200

71. Anhydrous Disodium Edetate

72. Veresene Disodium Salt

73. Edetate Disodium, Anhydrous

74. 8nlq36f6mm

75. Ethylenediaminetetraacetic Acid Disodium Salt Solution

76. Ethylenediaminetetraacetic Acid Disodium Salt, 0.050m Standardized Solution

77. Disodium 2-({2-[(carboxylatomethyl)(carboxymethyl)amino]ethyl}(carboxymethyl)amino)acetate

78. Chebi:64734

79. Acetic Acid, (ethylenedinitrilo)tetra-, Disodium Salt

80. Nsc-2760

81. Ccris 3658

82. E.d.t.a. Disodique [french]

83. F 1 (van)

84. E.d.t.a. Disodique

85. Nsc-759604

86. Nsc 2760

87. Einecs 205-358-3

88. Unii-8nlq36f6mm

89. Ethylenediamine Tetraacetic Acid Disodium Salt

90. Dinatrium Ethylendiamintetraacetat [czech]

91. Ai3-18049

92. Ethylenebis(iminodiacetic Acid) Disodium Salt

93. Dinatrium Ethylendiamintetraacetat

94. Hsdb 8013

95. Disodium 2-((2-((carboxylatomethyl)(carboxymethyl)amino)ethyl)(carboxymethyl)amino)acetate

96. (ethylenedinitrilo)-tetraacetic Acid Disodium Salt

97. Na2edta

98. 0.5m Sodium Edta

99. Disodium Edetate (tn)

100. Na2.edta

101. N,n'-1,2-ethanediylbis(n-(carboxymethyl)glycine) Disodium Salt

102. Ec 205-358-3

103. Edta Disodium Salt Anhydrous

104. Chembl1749

105. Dtxsid9027073

106. Disodium N,n'-1,2-ethanediylbis(n-(carboxymethyl)glycine)

107. Disodium Ethylenediamine-tetraacetate

108. Db14600

109. Sb40706

110. E386

111. Ethylenediaminetetracetic Acid Disodium Salt

112. Db-042467

113. Ethylenediaminetetra-acetic Acid Disodium Salt

114. D03945

115. P17519

116. J-007267

117. J-521348

118. Q4532977

119. Glycine, N,n'-1,2-ethanediylbis(n-(carboxymethyl)-, Sodium Salt (1:2)

120. (ethylenedinitrilo)tetraacetic Acid Disodium Salt, Edta Disodium Salt, Edta-na2

121. Disodium;2-[2-[carboxylatomethyl(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetate

122. Ethylenediaminetetraacetic Acid Disodium Salt, 0.100n (0.050m) Standardized Solution

123. Ethylenediaminetetraacetic Acid Disodium Salt, 0.115n (0.0575m) Standardized Solution

124. Ethylenediaminetetraacetic Acid Disodium Salt, 0.200n (0.1m) Standardized Solution

125. Disodium 2-({2-[(carboxylatomethyl)(carboxymethyl)amino]ethyl(carboxymethyl)amino)acetate

2.3 Create Date

2005-03-27

3 Chemical and Physical Properties

Molecular Formula	C₁₀H₁₄N₂Na₂O₈
Molecular Weight	336.21 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	10
Rotatable Bond Count	9
Exact Mass	336.05455397 g/mol
Monoisotopic Mass	336.05455397 g/mol
Topological Polar Surface Area	161 Å²
Heavy Atom Count	22
Formal Charge	0
Complexity	336
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	3

4 Drug and Medication Information

4.1 Therapeutic Uses

Anticoagulants; Chelating Agents; Food Additives

National Library of Medicine's Medical Subject Headings online file (MeSH, 2009)

Endrate (Edetate Disodium Injection, USP) is indicated in selected patients for the emergency treatment of hypercalcemia and for the control of ventricular arrhythmias associated with digitalis toxicity. /Included in US product label/

US Natl Inst Health; DailyMed. Current Medication Information for Endrate (edetate disodium, anhydrous) injection, solution (May 2006). Available from, as of February 16, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=290c3e9c-c0c6-440a-1a9c-46e3e2b07a77

Disodium edentate is also used therapeutically as an anticoagulant as it will chelate calcium and prevent the coagulation of blood in vitro. Concentrations of 0.1% w/v are used in small volumes for hematological testing and 0.3% w/v in transfusions.

Rowe, R.C., Sheskey, P.J., Quinn, M.E.; (Eds.), Handbook of Pharmaceutical Excipients 6th edition Pharmaceutical Press, London, England 2009, p. 243

Disodium EDTA is used occasionally to terminate the effects of injected calcium, to antagonize digitalis toxicity, or to suppress tachyarrhythmias. /Former/

Cosmetic Ingredient Expert Review Panel; Final Final Report on the Safety Assessment of EDTA, Calcium, Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA. International Journal of Toxicology 21 (S2): 95-142 (2002)

For more Therapeutic Uses (Complete) data for Disodium EDTA (8 total), please visit the HSDB record page.

4.2 Drug Warning

/BOXED WARNING/ The use of this drug in any particular patient is recommended only when the severity of the clinical condition justifies the aggressive measures associated with this type of therapy.

US Natl Inst Health; DailyMed. Current Medication Information for Endrate (edetate disodium, anhydrous) injection, solution (May 2006). Available from, as of February 16, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=290c3e9c-c0c6-440a-1a9c-46e3e2b07a77

Clinical studies of edetate disodium did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

US Natl Inst Health; DailyMed. Current Medication Information for Endrate (edetate disodium, anhydrous) injection, solution (May 2006). Available from, as of February 16, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=290c3e9c-c0c6-440a-1a9c-46e3e2b07a77

Fatal medication errors have occurred that involve confusion between edetate calcium disodium (calcium EDTA) and edetate disodium (no longer commercially available in the US). Children and adults have mistakenly received edetate disodium instead of edetate calcium disodium; at least 5 deaths have occurred as a result of inadvertent administration of edetate disodium. Although both edetate calcium disodium and edetate disodium are heavy metal antagonists, the 2 drugs were originally approved by the US Food and Drug Administration (FDA) for different uses and have different effects; edetate disodium was formerly FDA approved for use in selected patients for the emergency treatment of hypercalcemia or for the control of ventricular arrhythmias associated with cardiac glycoside toxicity. Use of edetate disodium may result in a substantial, and sometimes fatal, decrease in serum calcium concentrations. In June 2008, FDA withdrew its prior approval for edetate disodium because of safety concerns following a review of the risk-benefit profile of the drug. FDA stated that it was not considering additional action regarding edetate calcium disodium at that time; most of the fatalities following administration of an EDTA drug have involved medication errors in which edetate disodium was administered instead of edetate calcium disodium. FDA has not received reports of any fatalities resulting from the administration of edetate calcium disodium that involve a medication error.

American Society of Health-System Pharmacists 2011; Drug Information 2011. Bethesda, MD. 2011

Edetate Disodium Injection is contraindicated in anuric patients. It is not indicated for the treatment of generalized arteriosclerosis associated with advancing age.

US Natl Inst Health; DailyMed. Current Medication Information for Endrate (edetate disodium, anhydrous) injection, solution (May 2006). Available from, as of February 16, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=290c3e9c-c0c6-440a-1a9c-46e3e2b07a77

For more Drug Warnings (Complete) data for Disodium EDTA (22 total), please visit the HSDB record page.

4.3 Drug Indication

Edetate disodium is indicated for emergency treatment of hypercalcemia and digitalis toxicity associated ventricular arrhythmias.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Edetate disodium anhydrous is a polyvalent ion chelator that reduces blood concentrations of calcium or digitalis. It has a long duration of action as patients are generally given 1 daily dose. The therapeutic index is wide, as high doses are generally well tolerated. Patients should be counselled regarding the risk of postural hypotension, effects of myocardial contractility, hypokalemia, hypomagnesemia, and hypoglycemia.

5.2 MeSH Pharmacological Classification

Anticoagulants

Agents that prevent BLOOD CLOTTING. (See all compounds classified as Anticoagulants.)

Calcium Chelating Agents

Substances that bind to and sequester CALCIUM ions. (See all compounds classified as Calcium Chelating Agents.)

Food Additives

Substances used in the processing or storage of foods or animal feed including ANTIOXIDANTS; FOOD PRESERVATIVES; FOOD COLORING AGENTS; FLAVORING AGENTS; ANTI-INFECTIVE AGENTS; EXCIPIENTS and other similarly used substances. Many of the same substances are used as PHARMACEUTIC AIDS. (See all compounds classified as Food Additives.)

5.3 FDA Pharmacological Classification

5.3.1 Pharmacological Classes

Calcium Chelating Activity [MoA]; Decreased Coagulation Factor Activity [PE]; Lead Chelating Activity [MoA]; Lead Chelator [EPC]; Anti-coagulant [EPC]

5.4 Absorption, Distribution and Excretion

Route of Elimination

After intravenous administration, 95% of the dose is recovered in the urine after 24 hours. Oral administration in rats leads to 5.3% recovery in urine and 88.5% recovery in feces.

Volume of Distribution

Data regarding the volume of distribution of edetate disodium anhydrous is not readily available.

Clearance

The mean clearance of edetate in 1 month olds is 54.6mL/min/1.73m². 2-17 year olds have a mean clearance of 113.9 24.4 mL/min/1.73m².

After intravenous administration, the chelate formed is excreted in the urine with 50% appearing in 1 hour and over 95% in 24 hours.

US Natl Inst Health; DailyMed. Current Medication Information for Endrate (edetate disodium, anhydrous) injection, solution (May 2006). Available from, as of February 16, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=290c3e9c-c0c6-440a-1a9c-46e3e2b07a77

Disodium edentate ... /is/ poorly absorbed from the gastrointestinal tract and /is/ associated with few adverse effects when used as an excipient in pharmaceutical preparations.

Rowe, R.C., Sheskey, P.J., Quinn, M.E.; (Eds.), Handbook of Pharmaceutical Excipients 6th edition Pharmaceutical Press, London, England 2009, p. 243

Twenty male Sprague-Dawley rats were divided into four groups of five animals each. Rats in group 1 received ip injections of (14)C Disodium EDTA, group 2 received this compound on depilated skin, rats in group 3 received this compound on depilated and abraded skin (abraded every 2 or 3 cm over treated area), and group 4 was the control group. The specific activity of the (14)C Disodium EDTA was 21.6 mCi/mM and it was dissolved in saline to yield a final solution of 50 pCi/mL. Animals that received ip injections got 0.5 mL of this solution, or 25 pCi of (14)C Disodium EDTA. Animals that had the compound applied to the skin received 25 pCi of (14)C Disodium EDTA in the form of an ointment (modulan, mineral oil, petrolatum, cetyl alcohol 35:21 :25:12) spread over an area of 50 sq cm spread over a sheet of thin polyethylene. This sheet was taped to the trunk of each animal. A collar was fixed around the neck of the rats. All animals were decapitated 24 hours after treatment. The tissue distribution (per 100 mg wet organ weight) of (14)C Disodium EDTA 24 hours after ip administration was as follows: liver 577+/- 13, small intestine 631 +/- 25, large intestine 696 +/- 19, and kidney 1964 +/- 220. Twenty-four hours after application on normal skin the tissue distribution was as follows: liver 6 +/- 4, small intestine 99 +/- 22, large intestine 107 +/- 24, and kidneys 29 +/- 12. Twenty-four hours after application on abraded skin the tissue distribution was as follows: liver 139 +/- 34, small intestine 214 +/- 76, large intestine 309 +/- 115, and kidneys 222 +/- 30.

Cosmetic Ingredient Expert Review Panel; Final Final Report on the Safety Assessment of EDTA, Calcium, Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA. International Journal of Toxicology 21 (S2): 95-142 (2002)

/Investigators/ reported that rats fed 0.5%, 1.0%, and 5.0% Disodium EDTA for 12 weeks excreted 82.2%, 44.5%, and 45.4%, respectively, of the ingested dose in the urine and feces. The feces contained 99.4%, 98.2%, and 97.5% of the excreted material and the urine contained 0.6%, 1.8%, and 2.5% of the material for the respective doses.

Cosmetic Ingredient Expert Review Panel; Final Final Report on the Safety Assessment of EDTA, Calcium, Disodium EDTA, Diammonium EDTA, Dipotassium EDTA, Disodium EDTA, TEA-EDTA, Tetrasodium EDTA, Tripotassium EDTA, Trisodium EDTA, HEDTA, and Trisodium HEDTA. International Journal of Toxicology 21 (S2): 95-142 (2002)

For more Absorption, Distribution and Excretion (Complete) data for Disodium EDTA (7 total), please visit the HSDB record page.

5.5 Metabolism/Metabolites

Edetate is almost completely unmetabolized _in vivo_.

5.6 Biological Half-Life

After intravenous administration, the chelate formed is excreted in the urine with 50% appearing in 1 hour and over 95% in 24 hours.

US Natl Inst Health; DailyMed. Current Medication Information for Endrate (edetate disodium, anhydrous) injection, solution (May 2006). Available from, as of February 16, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=290c3e9c-c0c6-440a-1a9c-46e3e2b07a77

5.7 Mechanism of Action

Edetate disodium anhydrous chelates divalent and trivalent ions such as magnesium, zinc, and calcium. The chelate is excreted in the urine, reducing concentrations of these ions in the blood.

Edetate disodium injection forms chelates with the cations of calcium and many divalent and trivalent metals. Because of its affinity for calcium, edetate disodium will produce a lowering of the serum calcium level during intravenous infusion. Slow infusion over a protracted period may cause mobilization of extracirculatory calcium stores. Edetate disodium exerts a negative inotropic effect upon the heart.

US Natl Inst Health; DailyMed. Current Medication Information for Endrate (edetate disodium, anhydrous) injection, solution (May 2006).

Edetate disodium likewise forms chelates with other polyvalent metals and produces increases in urinary excretion of magnesium, zinc and other trace elements. It does not form a chelate with potassium but may reduce the serum level and increase urinary loss of potassium.

US Natl Inst Health; DailyMed. Current Medication Information for Endrate (edetate disodium, anhydrous) injection, solution (May 2006). Available from, as of February 16, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=290c3e9c-c0c6-440a-1a9c-46e3e2b07a77

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[{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643826600,"product":"EDETATE DISODIUM (DISODIUM EDETATE) (BIO","address":"212 ASHIRWAD COMMERCIAL COMPLEX,D- 1 GREEN PARK,","city":"NEW DELHI,DELHI","supplier":"SENTISS PHARMA","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"R K PHARMA INC","customerCountry":"UNITED STATES","quantity":"0.76","actualQuantity":"0.76","unit":"KGS","unitRateFc":"13538.3","totalValueFC":"120.1","currency":"INR","unitRateINR":11842.105263157895,"date":"03-Feb-2022","totalValueINR":"9000","totalValueInUsd":"120.1","indian_port":"DELHI AIR","hs_no":"29212100","bill_no":"7957701","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"212 ASHIRWAD COMMERCIAL COMPLEX,D- 1 GREEN PARK,, NEW DELHI,DELHI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666377000,"product":"EDETATE DISODIUM DIHYDRATE WS","address":"212 ASHIRWAD COMMERCIAL COMPLEX,D- 1 GREEN PARK,","city":"NEW DELHI,DELHI","supplier":"SENTISS PHARMA","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"R K PHARMA INC","customerCountry":"UNITED STATES","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"21608.2","totalValueFC":"12.2","currency":"INR","unitRateINR":20000,"date":"22-Oct-2022","totalValueINR":"1000","totalValueInUsd":"12.2","indian_port":"DELHI AIR","hs_no":"29339990","bill_no":"5015574","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"212 ASHIRWAD COMMERCIAL COMPLEX,D- 1 GREEN PARK,, NEW DELHI,DELHI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695407400,"product":"ORGANIC CHEMICALS...CHAPTER 29 AS PER INVOICE NUMBER. EXP-119 FOR INDUSTRIAL USE ONLY EDETATE CALCIUM DISODIUM DIHYDRATE","address":"23, MEHABOOB MANSION, 2ND","city":"MUMBAI, MAHARASHTRA","supplier":"ANMOL CHEMICALS PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"JAKARTA SOEKARNO-HA","customer":"TO ORDER","customerCountry":"INDONESIA","quantity":"0.45","actualQuantity":"450","unit":"GMS","unitRateFc":"29","totalValueFC":"12842.1","currency":"USD","unitRateINR":2368.8888888888887,"date":"23-Sep-2023","totalValueINR":"1066000","totalValueInUsd":"12842.1","indian_port":"Bombay Air","hs_no":"29224990","bill_no":"4135594","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"23, MEHABOOB MANSION, 2ND, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1706034600,"product":"EDETATE DISODIUM USP BATCH NO. 1223\/EDS2048 MFG DT. DECEMBER 2023 EXP DT. NOVEMBER 2028","address":"SHED NO: 875\/2","city":"VADODARA","supplier":"SUJATA NUTRI-PHARMA PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"PAJALA","customer":"THE ORDER OF.","customerCountry":"MALAYSIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"200","totalValueFC":"881.8","currency":"USD","unitRateINR":14658.299999999999,"date":"24-Jan-2024","totalValueINR":"73291.5","totalValueInUsd":"881.8","indian_port":"Ahmedabad Air","hs_no":"29212100","bill_no":"6973028","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MALAYSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"SHED NO: 875\/2, VADODARA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1635877800,"product":"EDETATE DISODIUM DIHYDRATE USP 500G (QTY 1PAC X 500G=500G) (PHARMA GRADE)","address":"306, STUDIO COMPLEX, NEAR GOTA CHAR RASTA, GOTA,","city":"AHMEDABAD -","supplier":"SPECTRUM CHEMICAL","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"TEKNIRVANA TRADELINK PRIVATE ","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"317.9","totalValueFC":"219.3","currency":"USD","unitRateINR":"32660.7","date":"03-Nov-2021","totalValueINR":"16330.37","totalValueInUsd":"219.3","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"6112185","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"306, STUDIO COMPLEX, NEAR GOTA CHAR RASTA, GOTA,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654281000,"product":"EDETATE DISODIUM DIHYDRATE, USP","address":"G-A 48, LAKE CITY MALL, KAPURBAWDI ,CIRCLE, MAJIWADA, THANE WEST,","city":"THANE,MAHARASHTRA","supplier":"SPECTRUM CHEMICLE MFG CORP","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"PLANET SCIENCE","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"339.9","totalValueFC":"192.3","currency":"USD","unitRateINR":"29999.3","date":"04-Jun-2022","totalValueINR":"14999.63","totalValueInUsd":"192.3","indian_port":"BOMBAY AIR","hs_no":"29224990","bill_no":"8971695","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"G-A 48, LAKE CITY MALL, KAPURBAWDI ,CIRCLE, MAJIWADA, THANE WEST,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1666031400,"product":"BAKR8995-07 EDETATE DISODIUM MULTICHOMPCGMP(EACH NO=12 KGS)(15 NOS=180 KGS)","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"AVANTOR","supplierCountry":"UNITED STATES","foreign_port":"N\/A","customer":"PFIZER INC","customerCountry":"INDIA","quantity":"180.00","actualQuantity":"180","unit":"KGS","unitRateFc":"59.1","totalValueFC":"10651.3","currency":"USD","unitRateINR":"4869.1","date":"18-Oct-2022","totalValueINR":"876435","totalValueInUsd":"10651.3","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29212100","bill_no":"1001745","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1675103400,"product":"EDETATE DISODIUM BATCH NO-1913637(FOR R&D)","address":"B-310, SOM DATT CHAMBERS, 1,,BHIKA JI CAMA PLACE,","city":"NEW DELHI,DELHI","supplier":"FRESENIUS SE & CO. KGAA","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"FRESENIUS SE & CO. KGAA","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"20","unit":"GMS","unitRateFc":"0.5","totalValueFC":"10.1","currency":"USD","unitRateINR":"41.2","date":"31-Jan-2023","totalValueINR":"823","totalValueInUsd":"10.1","indian_port":"DELHI AIR","hs_no":"29212100","bill_no":"4421838","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B-310, SOM DATT CHAMBERS, 1,,BHIKA JI CAMA PLACE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1675362600,"product":"EDETATE DISODIUM DIHYDRATE USP (EXCIPIENT)(FREE OF COST)","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"PAR PHARMACEUTICAL","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"PAR PHARMACEUTICAL","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"50","unit":"GMS","unitRateFc":"0.2","totalValueFC":"544.9","currency":"USD","unitRateINR":"900.1","date":"03-Feb-2023","totalValueINR":"45003.59","totalValueInUsd":"544.9","indian_port":"BOMBAY AIR","hs_no":"29224990","bill_no":"4476183","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689273000,"product":"VERSENE NA DR400 USP-FCC ( EDETATE DISODIUM)","address":"803, 8TH FLOOR,,HDIL B WING, KALED ONIA, SAHAR ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"UNIVAR SOLUTIONS USA ","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"ENCUBE ETHICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"45.36","actualQuantity":"45.36","unit":"KGS","unitRateFc":"41.3","totalValueFC":"2613.1","currency":"USD","unitRateINR":"4734.8","date":"14-Jul-2023","totalValueINR":"214772.39","totalValueInUsd":"2613.1","indian_port":"BOMBAY AIR","hs_no":"29224990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"803, 8TH FLOOR,,HDIL B WING, KALED ONIA, SAHAR ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698949800,"product":"EDETATE DISODIUM, DIHYDRATE, USP ( 2 X 0.5 KGS )","address":"C1003,LALANI RESIDENCY,OPP SURAJ,W","city":"THANE WEST,MAHARASHTRA","supplier":"RIA INTERNATIONAL LLC","supplierCountry":"UNITED STATES","foreign_port":"NEW YORK - JOHN F. K","customer":"PHARMONIX BIOLOGICALS PRIVATE ","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"524.6","totalValueFC":"713.6","currency":"USD","unitRateINR":"59426","date":"03-Nov-2023","totalValueINR":"59426.03","totalValueInUsd":"713.6","indian_port":"Bombay Air","hs_no":"29224990","bill_no":"8611278","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK - JOHN F. K","supplierAddress":"11 MELANIE LN 17EAST HANOVER, NJ 07936SDNF UNITED STATES","customerAddress":"C1003,LALANI RESIDENCY,OPP SURAJ,W"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699209000,"product":"(FOC) 4000015451 EDETATE DISODIUM USP (FOR R & D PURPOSE ONLY)","address":"21-22, KALPATARU SQUARE, KONDIVITA","city":"ANDHERI (E), MUMBAI,MAHARASHTRA","supplier":"ACTAVIS INC","supplierCountry":"UNITED STATES","foreign_port":"NEWARK, NJ","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"2.06","actualQuantity":"2.057","unit":"KGS","unitRateFc":"869.2","totalValueFC":"2168.1","currency":"USD","unitRateINR":"87767.8","date":"06-Nov-2023","totalValueINR":"180538.32","totalValueInUsd":"2168.1","indian_port":"Bombay Air","hs_no":"29420090","bill_no":"8650948","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEWARK, NJ","supplierAddress":"577 Chipeta Way Salt Lake City, UT84108SDNF United States","customerAddress":"21-22, KALPATARU SQUARE, KONDIVITA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719599400,"product":"(F.O.C.) EDETATE DISODIUM (FOR TESTING PURPOSE ONLY)","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"ALLERGAN AESTHETICS","supplierCountry":"ITALY","foreign_port":"DUBLIN","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"20","unit":"GMS","unitRateFc":"0.1","totalValueFC":"1","currency":"USD","unitRateINR":"4.2","date":"29-Jun-2024","totalValueINR":"84.3","totalValueInUsd":"1","indian_port":"Bombay Air","hs_no":"29224990","bill_no":"4255348","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBLIN","supplierAddress":"CASTLEBAR ROAD WESTPORT CO MAYO F28 AW83SDNF Ireland","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"}]

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

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ABOUT THIS PAGE

Edetate Calcium Disodium Manufacturers

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

Edetate Calcium Disodium Suppliers

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

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

Edetate Calcium Disodium USDMF

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

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

click here to find a list of Edetate Calcium Disodium suppliers with USDMF on PharmaCompass.

Edetate Calcium Disodium 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 Edetate Calcium Disodium as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Edetate Calcium Disodium suppliers with NDC on PharmaCompass.

Edetate Calcium Disodium GMP

Edetate Calcium Disodium 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 Edetate Calcium Disodium 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 Edetate Calcium Disodium GMP manufacturer or Edetate Calcium Disodium GMP API supplier for your needs.

Edetate Calcium Disodium CoA

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

Edetate Calcium Disodium CoA mostly includes findings from lab analyses of a specific batch. For each Edetate Calcium Disodium 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.

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