Synopsis
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KDMF
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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
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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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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.
A Picolax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Picolax, including repackagers and relabelers. The FDA regulates Picolax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Picolax 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 Picolax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Picolax supplier is an individual or a company that provides Picolax active pharmaceutical ingredient (API) or Picolax finished formulations upon request. The Picolax suppliers may include Picolax API manufacturers, exporters, distributors and traders.
click here to find a list of Picolax suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Picolax DMF (Drug Master File) is a document detailing the whole manufacturing process of Picolax active pharmaceutical ingredient (API) in detail. Different forms of Picolax DMFs exist exist since differing nations have different regulations, such as Picolax USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Picolax DMF submitted to regulatory agencies in the US is known as a USDMF. Picolax USDMF includes data on Picolax's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Picolax USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Picolax 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 Picolax Drug Master File in Japan (Picolax JDMF) empowers Picolax 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 Picolax JDMF during the approval evaluation for pharmaceutical products. At the time of Picolax 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 Picolax suppliers with JDMF on PharmaCompass.
A Picolax CEP of the European Pharmacopoeia monograph is often referred to as a Picolax Certificate of Suitability (COS). The purpose of a Picolax CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Picolax EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Picolax to their clients by showing that a Picolax CEP has been issued for it. The manufacturer submits a Picolax CEP (COS) as part of the market authorization procedure, and it takes on the role of a Picolax CEP holder for the record. Additionally, the data presented in the Picolax CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Picolax DMF.
A Picolax CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Picolax 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 Picolax suppliers with CEP (COS) on PharmaCompass.
A Picolax written confirmation (Picolax WC) is an official document issued by a regulatory agency to a Picolax manufacturer, verifying that the manufacturing facility of a Picolax active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Picolax APIs or Picolax finished pharmaceutical products to another nation, regulatory agencies frequently require a Picolax WC (written confirmation) as part of the regulatory process.
click here to find a list of Picolax 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 Picolax as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Picolax 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 Picolax 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 Picolax and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Picolax NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Picolax suppliers with NDC on PharmaCompass.
Picolax 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 Picolax 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 Picolax GMP manufacturer or Picolax GMP API supplier for your needs.
A Picolax CoA (Certificate of Analysis) is a formal document that attests to Picolax's compliance with Picolax specifications and serves as a tool for batch-level quality control.
Picolax CoA mostly includes findings from lab analyses of a specific batch. For each Picolax 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.
Picolax may be tested according to a variety of international standards, such as European Pharmacopoeia (Picolax EP), Picolax JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Picolax USP).
