Synopsis
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KDMF
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VMF
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FDF
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Australia
DRUG PRODUCT COMPOSITIONS0
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1. 4,4'-(2-picolylidene)bisphenylsulfuric Acid
2. 4,4'-(picoliliden)-bis-phenylsulphate
3. Laxoberal
4. Picolax
5. Picoprep
6. Picosulfate Sodium
7. Picosulfol
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
| Molecular Weight | 481.4 g/mol |
|---|---|
| Molecular Formula | C18H13NNa2O8S2 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 9 |
| Rotatable Bond Count | 5 |
| Exact Mass | 480.98779728 g/mol |
| Monoisotopic Mass | 480.98779728 g/mol |
| Topological Polar Surface Area | 163 Ų |
| Heavy Atom Count | 31 |
| Formal Charge | 0 |
| Complexity | 633 |
| 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 |
Cathartics
Agents that are used to stimulate evacuation of the bowels. (See all compounds classified as Cathartics.)
A - Alimentary tract and metabolism
A06 - Drugs for constipation
A06A - Drugs for constipation
A06AB - Contact laxatives
A06AB08 - Sodium picosulfate
API SUPPLIERS
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USDMF
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
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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
DOSAGE - SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;1...DOSAGE - SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;10MG/BOT
USFDA APPLICATION NUMBER - 209589
Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
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ABOUT THIS PAGE
A Sodium Picosulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Picosulfate, including repackagers and relabelers. The FDA regulates Sodium Picosulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Picosulfate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Sodium Picosulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Picosulfate supplier is an individual or a company that provides Sodium Picosulfate active pharmaceutical ingredient (API) or Sodium Picosulfate finished formulations upon request. The Sodium Picosulfate suppliers may include Sodium Picosulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Picosulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Picosulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Picosulfate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Picosulfate DMFs exist exist since differing nations have different regulations, such as Sodium Picosulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Picosulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Picosulfate USDMF includes data on Sodium Picosulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Picosulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Picosulfate suppliers with USDMF on PharmaCompass.
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 Sodium Picosulfate Drug Master File in Japan (Sodium Picosulfate JDMF) empowers Sodium Picosulfate 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 Sodium Picosulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium Picosulfate 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 Sodium Picosulfate suppliers with JDMF on PharmaCompass.
A Sodium Picosulfate CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Picosulfate Certificate of Suitability (COS). The purpose of a Sodium Picosulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Picosulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Picosulfate to their clients by showing that a Sodium Picosulfate CEP has been issued for it. The manufacturer submits a Sodium Picosulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Picosulfate CEP holder for the record. Additionally, the data presented in the Sodium Picosulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Picosulfate DMF.
A Sodium Picosulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium Picosulfate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Sodium Picosulfate suppliers with CEP (COS) on PharmaCompass.
A Sodium Picosulfate written confirmation (Sodium Picosulfate WC) is an official document issued by a regulatory agency to a Sodium Picosulfate manufacturer, verifying that the manufacturing facility of a Sodium Picosulfate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sodium Picosulfate APIs or Sodium Picosulfate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sodium Picosulfate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sodium Picosulfate suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Sodium Picosulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium Picosulfate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Sodium Picosulfate 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.
The NDC directory also contains data on finished compounded human drug products that contain Sodium Picosulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Picosulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium Picosulfate suppliers with NDC on PharmaCompass.
Sodium Picosulfate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Sodium Picosulfate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Sodium Picosulfate GMP manufacturer or Sodium Picosulfate GMP API supplier for your needs.
A Sodium Picosulfate CoA (Certificate of Analysis) is a formal document that attests to Sodium Picosulfate's compliance with Sodium Picosulfate specifications and serves as a tool for batch-level quality control.
Sodium Picosulfate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Picosulfate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Sodium Picosulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Picosulfate EP), Sodium Picosulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Picosulfate USP).
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