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Also known as: 10040-45-6, Picosulfate sodium, Laxoberal, Laxoberon, Sodium picosulphate, Evacuol
Molecular Formula
C18H13NNa2O8S2
Molecular Weight
481.4  g/mol
InChI Key
GOZDTZWAMGHLDY-UHFFFAOYSA-L
FDA UNII
VW106606Y8

Sodium Picosulfate
1 2D Structure

Sodium Picosulfate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
disodium;[4-[pyridin-2-yl-(4-sulfonatooxyphenyl)methyl]phenyl] sulfate
2.1.2 InChI
InChI=1S/C18H15NO8S2.2Na/c20-28(21,22)26-15-8-4-13(5-9-15)18(17-3-1-2-12-19-17)14-6-10-16(11-7-14)27-29(23,24)25;;/h1-12,18H,(H,20,21,22)(H,23,24,25);;/q;2*+1/p-2
2.1.3 InChI Key
GOZDTZWAMGHLDY-UHFFFAOYSA-L
2.1.4 Canonical SMILES
C1=CC=NC(=C1)C(C2=CC=C(C=C2)OS(=O)(=O)[O-])C3=CC=C(C=C3)OS(=O)(=O)[O-].[Na+].[Na+]
2.2 Other Identifiers
2.2.1 UNII
VW106606Y8
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4,4'-(2-picolylidene)bisphenylsulfuric Acid

2. 4,4'-(picoliliden)-bis-phenylsulphate

3. Laxoberal

4. Picolax

5. Picoprep

6. Picosulfate Sodium

7. Picosulfol

2.3.2 Depositor-Supplied Synonyms

1. 10040-45-6

2. Picosulfate Sodium

3. Laxoberal

4. Laxoberon

5. Sodium Picosulphate

6. Evacuol

7. Picolax

8. Neopax

9. Guttalax-fher

10. Pico-salax

11. Da-1773

12. 4,4'-(2-picolylidene)bis(phenylsulfuric Acid) Disodium Salt

13. La 391

14. Picosulfate Sodium Anhydrous

15. Sodium Picosulfate Anhydrous

16. Anhydrous Sodium Picosulfate

17. Da 1773

18. Sodium Picosulphate Anhydrous

19. Picosulfol

20. Guttalax

21. Rapilax

22. Chebi:32147

23. 4,4'-(2-pyridylmethylene)diphenol Bis(hydrogen Sulfate) Disodium Salt

24. Vw106606y8

25. Laxidogol

26. Evanol

27. Disodium;[4-[pyridin-2-yl-(4-sulfonatooxyphenyl)methyl]phenyl] Sulfate

28. Sodium Picosulfate 100 Microg/ml In Acetonitrile

29. Picosulfate Sodium Hydrate

30. Picoprep

31. Natrii Picosulfas

32. Sodium Picosulphate Monohydrate

33. Picosulfato Sodico

34. Disodium 4,4'-(2-pyridylmethylene)-di(phenyl Sulphate);disodium 4,4'-(2-pyridylmethylene)-di(phenyl Sulphate);sodium Picosulfate

35. Natrii Picosulfas [inn-latin]

36. Picosulfate De Sodium

37. La-391

38. Picosulfato Sodico [inn-spanish]

39. Ncgc00182711-01

40. Picosulfate De Sodium [inn-french]

41. Sodium Picosulfate [inn:ban:jan]

42. Einecs 233-120-9

43. 2-picolylidenebis(p-phenyl Sodium Sulfate)

44. Natriumpicosulfat

45. Unii-vw106606y8

46. Guttalax;laxoberon

47. Disodium 4,4'-disulfoxydiphenyl-(2-pyridyl)methane

48. Bisacodyl Impurity D

49. 4-methyl-2-pentenoicacid

50. 4,4'-(2-pyridylmethylene)diphenolbis(hydrogen Sulfate) (ester) Disodium Salt

51. 4,4'-(2-pyridinylmethylene)bisphenol Bis(hydrogen Sulfate) (ester) Disodium Salt

52. Dsstox_cid_28589

53. Dsstox_rid_82860

54. Dsstox_gsid_48663

55. Schembl346436

56. Picosulfate Sodium [mi]

57. Chembl1697768

58. Dtxsid7048663

59. Sodium Picosulfate [inn]

60. Picosulfate For System Suitability

61. Hms3652k17

62. Bcp11522

63. Tox21_113026

64. Mfcd00867640

65. S4020

66. 4,4'-(2-pyridinylmethylene)bisphenol 1,1'-bis(hydrogen Sulfate) Sodium Salt

67. Phenol, 4,4'-(2-pyridylmethylene)bis-, Bis(hydrogen Sulfate), Disodium Salt

68. Ccg-269559

69. Ac-31735

70. As-15785

71. Cas-10040-45-6

72. Ft-0673898

73. S0936

74. Sw219183-1

75. C71029

76. Q410265

77. Sodium (pyridin-2-ylmethylene)bis(4,1-phenylene) Bis(sulfate)

78. Sodium 4,4'-(pyridin-2-ylmethylene)bis(4,1-phenylene) Disulfate

79. 4,4'-(2-pyridylmethylene)diphenol Bis(hydrogen Sulphate) Disodium Salt

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 481.4 g/mol
Molecular Formula C18H13NNa2O8S2
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count9
Rotatable Bond Count5
Exact Mass480.98779728 g/mol
Monoisotopic Mass480.98779728 g/mol
Topological Polar Surface Area163 Ų
Heavy Atom Count31
Formal Charge0
Complexity633
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Cathartics

Agents that are used to stimulate evacuation of the bowels. (See all compounds classified as Cathartics.)


4.2 ATC Code

A - Alimentary tract and metabolism

A06 - Drugs for constipation

A06A - Drugs for constipation

A06AB - Contact laxatives

A06AB08 - Sodium picosulfate


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03-Jan-2022
28-Jun-2025
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DOSAGE - FOR SOLUTION;ORAL - 12GM/PACKET;3.5G...DOSAGE - FOR SOLUTION;ORAL - 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 202535

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DOSAGE - SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;1...DOSAGE - SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;10MG/BOT

USFDA APPLICATION NUMBER - 209589

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ABOUT THIS PAGE

Looking for 10040-45-6 / Sodium Picosulfate API manufacturers, exporters & distributors?

Sodium Picosulfate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Sodium Picosulfate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sodium Picosulfate manufacturer or Sodium Picosulfate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Picosulfate manufacturer or Sodium Picosulfate supplier.

PharmaCompass also assists you with knowing the Sodium Picosulfate API Price utilized in the formulation of products. Sodium Picosulfate API Price is not always fixed or binding as the Sodium Picosulfate Price is obtained through a variety of data sources. The Sodium Picosulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Sodium Picosulfate

Synonyms

10040-45-6, Picosulfate sodium, Laxoberal, Laxoberon, Sodium picosulphate, Evacuol

Cas Number

10040-45-6

Unique Ingredient Identifier (UNII)

VW106606Y8

Neopax Manufacturers

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

Neopax Suppliers

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

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

Neopax USDMF

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

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

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

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

Neopax CEP

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

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

Neopax WC

A Neopax written confirmation (Neopax WC) is an official document issued by a regulatory agency to a Neopax manufacturer, verifying that the manufacturing facility of a Neopax active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Neopax APIs or Neopax finished pharmaceutical products to another nation, regulatory agencies frequently require a Neopax WC (written confirmation) as part of the regulatory process.

click here to find a list of Neopax suppliers with Written Confirmation (WC) on PharmaCompass.

Neopax 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 Neopax as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Neopax GMP

Neopax 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 Neopax 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 Neopax GMP manufacturer or Neopax GMP API supplier for your needs.

Neopax CoA

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

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

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