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Tox21_300270

Tox21_300270

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

26 API Suppliers, 17 USDMF, 12 CEP/COS, 9 JDMF, 3 EU WC, 8 KDMF, 4 NDC API, 9 Listed Suppliers

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424 Dossiers, 78 FDA Orange Book, 217 Europe, 51 Canada, 36 Australia, 27 South Africa, 15 Listed Dossiers

DRUG PRODUCT COMPOSITION

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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Suppliers, 37 Kerry, 23 SPI Pharma, 21 BASF, 18 Roquette, 17 Microlex e.U, 11 Gangwal Healthcare, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 Sigachi Industries, 11 Corel Pharma Chem, 10 Gangwal Chemicals, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 7 Seppic, 7 Boai NKY Pharmaceuticals Ltd, 6 DFE Pharma, 6 Lonza Capsugel, 5 Ideal Cures Pvt Ltd, 4 Pharmatrans-Sanaq, 4 Prachin Chemical, 4 Ingredion Pharma Solutions, 4 Vasa Pharmachem, 3 Ulanqab Kema New Material, 3 Kima Chemical, 3 Nanjing Well Pharmaceutical, 2 The Dow Chemical Company, 2 Aeon Procare, 2 DKSH, 2 Alcedo Pharmachem, 2 Jai Radhe Sales, 1 Nanjing Bold Chemical, 1 ACG Worldwide, 1 Qualicaps, 1 Rochem International Inc, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 NEWEDGE Overseas, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Chynops Pharma, 1 Minakem, 1 Pfanstiehl

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GLOBAL SALES INFORMATION

16 US Medicaid Prescriptions, 211 Finished Drug Prices

MARKET PLACE

8 APIs, 2 DOSSIERS // FDF

PATENTS

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4 Health Canada Patents

ANALYTICAL SOLUTION(s)

3 EDQM Standards, 4 USP Standards, 6 JP Standards, 5 Other Ref. Standards

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2,555.00

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SERVICES

Also known as: 81131-70-6, Pravachol, Mevalotin, Selektine, Elisor, Pravaselect

Molecular Formula

C₂₃H₃₅NaO₇

Molecular Weight

446.5 g/mol

InChI Key

VWBQYTRBTXKKOG-IYNICTALSA-M

FDA UNII

3M8608UQ61

An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).

1 2D Structure

Tox21_300270

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;(3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[(2S)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate

2.1.2 InChI

InChI=1S/C23H36O7.Na/c1-4-13(2)23(29)30-20-11-17(25)9-15-6-5-14(3)19(22(15)20)8-7-16(24)10-18(26)12-21(27)28;/h5-6,9,13-14,16-20,22,24-26H,4,7-8,10-12H2,1-3H3,(H,27,28);/q;+1/p-1/t13-,14-,16+,17+,18+,19-,20-,22-;/m0./s1

2.1.3 InChI Key

VWBQYTRBTXKKOG-IYNICTALSA-M

2.1.4 Canonical SMILES

CCC(C)C(=O)OC1CC(C=C2C1C(C(C=C2)C)CCC(CC(CC(=O)[O-])O)O)O.[Na+]

2.1.5 Isomeric SMILES

CC[C@H](C)C(=O)O[C@H]1C[C@@H](C=C2[C@H]1[C@H]([C@H](C=C2)C)CC[C@H](C[C@H](CC(=O)[O-])O)O)O.[Na+]

2.2 Other Identifiers

2.2.1 UNII

3M8608UQ61

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Apo Pravastatin

2. Apo-pravastatin

3. Bristacol

4. Cs 514

5. Cs-514

6. Cs514

7. Elisor

8. Eptastatin

9. Lin Pravastatin

10. Lin-pravastatin

11. Lipemol

12. Liplat

13. Lipostat

14. Mevalotin

15. Nu Pravastatin

16. Nu-pravastatin

17. Prareduct

18. Pravachol

19. Pravacol

20. Pravasin

21. Pravastatin

22. Pravastatin Monosodium Salt, (6 Beta)-isomer

23. Pravastatin Sodium Salt

24. Pravastatin Tert Octylamine Salt

25. Pravastatin Tert-octylamine Salt

26. Pravastatin, (6 Beta)-isomer

27. Rms 431

28. Rms-431

29. Rms431

30. Selektine

31. Sodium Salt, Pravastatin

32. Sq 31,000

33. Sq 31000

34. Sq-31,000

35. Sq-31000

36. Sq31,000

37. Sq31000

38. Vasten

2.3.2 Depositor-Supplied Synonyms

1. 81131-70-6

2. Pravachol

3. Mevalotin

4. Selektine

5. Elisor

6. Pravaselect

7. Lipostat

8. Eptastatin Sodium

9. Cs-514

10. Pravastatin Sodium Salt

11. Pravastatin (sodium)

12. Dehypotin Protect

13. Sq-31000

14. Sq-31,000

15. Chebi:8361

16. Bristacol

17. Lipemol

18. Prareduct

19. Pravacol

20. Pravasin

21. 3m8608uq61

22. Nsc-759253

23. Sodium;(3r,5r)-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-[(2s)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate

24. Aplactin

25. Lipidal

26. Liprevil

27. Pralidon

28. Pravasine

29. Sanaprav

30. Selipran

31. Vasen

32. Epastatin Sodium

33. Dsstox_cid_27525

34. Dsstox_rid_82395

35. Dsstox_gsid_47525

36. Liplat

37. Vasten

38. Pravastatin, Sodium Salt

39. (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-(((s)-2-methylbutanoyl)oxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoic Acid, Sodium Salt

40. Cas-81131-70-6

41. Pravastatin Natrium Mayrho Fer

42. Sq 31000

43. 3-beta-hydroxycompactin Sodium Salt

44. Drg-0319

45. Chembl690

46. Unii-3m8608uq61

47. Cres Pravastatin

48. Pravachol (tn)

49. Ncgc00095183-01

50. Pravastatin Sodium [usan:usp:jan]

51. Mfcd00887601

52. Pravastatinsodium,(s)

53. Cs-514 Sodium

54. Pravastatin Sodium- Bio-x

55. Schembl3013

56. Sodium (+)-(betar,deltar,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-beta,delta,6,8-tetrahydroxy-2-methyl-1-naphthaleneheptanoate, 8-((2s)-2-methylbutyrate)

57. Pravastatin Sodium [mi]

58. Dtxsid6047525

59. Pravastatin Sodium [jan]

60. Hy-b0165a

61. Pravastatin Sodium (jp17/usp)

62. Pravastatin Sodium [usan]

63. Hms2051p05

64. Hms3268l20

65. Hms3413e20

66. Pravastatin Sodium [vandf]

67. Hexahydronaphthalen-1-yl)heptanoate

68. Pravastatin Sodium [mart.]

69. Amy40517

70. Pravastatin Sodium [usp-rs]

71. Pravastatin Sodium [who-dd]

72. Tox21_111474

73. Tox21_300270

74. S3036

75. Akos015896504

76. Akos015964902

77. Ccg-100926

78. Cs-2003

79. Nc00176

80. Nsc 759253

81. Pravastatin Sodium [orange Book]

82. Ncgc00092370-01

83. Ncgc00254232-01

84. Pravastatin Sodium [ep Monograph]

85. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-beta,delta,6-trihydroxy-, Monosodium Salt, (1s-(1-alpha(beta-s*,delta-s*),2-alpha,6-alpha,8-beta(r*),8a-alpha))-

86. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-beta,delta,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, Monosodium Salt, (1s-(1alpha(betas*,deltas*),2alpha,6alpha,8beta(r*),8aalpha))-

87. Bp164292

88. Pravastatin Sodium [usp Monograph]

89. P1796

90. D00893

91. Pravigard Pac Component Pravastatin Sodium

92. Pravastatin Sodium Component Of Pravigard Pac

93. Q27108059

94. Pravastatin Sodium Salt Hydrate, >=98% (hplc), Powder

95. 2-methyl-8-((s)-2-methylbutanoyloxy)-1,2,6,7,8,8a-

96. Sodium (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-

97. (?r,?r,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-?,?,6-trihydroxy-2-methyl-8-[(2s)-2-methyl-1-oxobutoxy]-1-naphthaleneheptanoic Acid Monosodium Salt

98. (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-(((s)-2-methylbutanoyl)oxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoicacid,sodiumsalt

99. 1-naphthaleneheptanoic Acid, 1,2,6,7,8,8a-hexahydro-.beta.,d,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, Monosodium Salt, (1s-(1.alpha.(.beta.s*,ds*),2.alpha.,6.alpha.,8.beta.(r*),8a.alpha.))-

100. Sodium (+)-(.beta.r,dr,1s,2s,6s,8s,8ar)-1,2,6,7,8,8a-hexahydro-.beta.,d,6,8-tetrahydroxy-2-methyl-1-naphthaleneheptanoate, 8-((2s)-2-methylbutyrate)

101. Sodium (3r,5r)-3,5-dihydroxy-7-((1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-((s)-2-methylbutanoyloxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoate

102. Sodium (3r,5r)-3,5-dihydroxy-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-{[(2s)-2-methylbutanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate

2.4 Create Date

2007-11-09

3 Chemical and Physical Properties

Molecular Formula	C₂₃H₃₅NaO₇
Molecular Weight	446.5 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	11
Exact Mass	446.22804773 g/mol
Monoisotopic Mass	446.22804773 g/mol
Topological Polar Surface Area	127 Å²
Heavy Atom Count	31
Formal Charge	0
Complexity	662
Isotope Atom Count	0
Defined Atom Stereocenter Count	8
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Pravachol
PubMed Health	Pravastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	PRAVACHOL (pravastatin sodium) is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in ch...
Active Ingredient	Pravastatin sodium
Dosage Form	Tablet
Route	Oral
Strength	10mg; 80mg; 40mg; 20mg
Market Status	Prescription
Company	Bristol Myers Squibb

2 of 4
Drug Name	Pravastatin sodium
Drug Label	Pravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase,...
Active Ingredient	Pravastatin sodium
Dosage Form	Tablet
Route	oral; Oral
Strength	10mg; 80mg; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Teva; Lupin Pharms; Apotex; Sandoz; Cipla; Watson Labs; Glenmark Generics; Teva Pharms; Pliva Hrvatska Doo; Zydus Pharms Usa; Dr Reddys Labs; Mylan

3 of 4
Drug Name	Pravachol
PubMed Health	Pravastatin (By mouth)
Drug Classes	Antihyperlipidemic
Drug Label	PRAVACHOL (pravastatin sodium) is one of a class of lipid-lowering compounds, the statins, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of HMG-CoA reductase, the enzyme catalyzing the early rate-limiting step in ch...
Active Ingredient	Pravastatin sodium
Dosage Form	Tablet
Route	Oral
Strength	10mg; 80mg; 40mg; 20mg
Market Status	Prescription
Company	Bristol Myers Squibb

4 of 4
Drug Name	Pravastatin sodium
Drug Label	Pravastatin sodium tablets are one of a class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, which reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase,...
Active Ingredient	Pravastatin sodium
Dosage Form	Tablet
Route	oral; Oral
Strength	10mg; 80mg; 40mg; 20mg
Market Status	Tentative Approval; Prescription
Company	Mylan Pharms; Teva; Lupin Pharms; Apotex; Sandoz; Cipla; Watson Labs; Glenmark Generics; Teva Pharms; Pliva Hrvatska Doo; Zydus Pharms Usa; Dr Reddys Labs; Mylan

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anticholesteremic Agents

Substances used to lower plasma cholesterol levels. (See all compounds classified as Anticholesteremic Agents.)

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Compounds that inhibit HYDROXYMETHYLGLUTARYL COA REDUCTASES. They have been shown to directly lower CHOLESTEROL synthesis. (See all compounds classified as Hydroxymethylglutaryl-CoA Reductase Inhibitors.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]; HMG-CoA Reductase Inhibitor [EPC]