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JDMF
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FDA Orange Book
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Canada
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1. Auxitrans
2. Hydrafuca
3. Pentaerythritol, Calcium, Zinc Salt
4. Pentaerythritol, Sodium Salt
1. 115-77-5
2. 2,2-bis(hydroxymethyl)propane-1,3-diol
3. Tetramethylolmethane
4. Penetek
5. Pentek
6. Metab-auxil
7. Monopentaerythritol
8. Pentaerythrite
9. Auxinutril
10. Maxinutril
11. Monopentek
12. Hercules P6
13. Tetrahydroxymethylmethane
14. Methane Tetramethylol
15. Tetrakis(hydroxymethyl)methane
16. 2,2-bis(hydroxymethyl)-1,3-propanediol
17. 1,3-propanediol, 2,2-bis(hydroxymethyl)-
18. Pentaerithrityl
19. Tetra(hydroxymethyl)methane
20. Thme
21. Pe 200
22. Auxitrans
23. 1,1,1-tris(hydroxymethyl)ethanol
24. Nsc 8100
25. Su420w1s6n
26. Nsc-8100
27. Dsstox_cid_6943
28. Dsstox_rid_78264
29. Dsstox_gsid_26943
30. 334974-06-0
31. 1,3-propanediol, 2,2-bis(hydroxymethyl)-, Homopolymer
32. Pentaerythrital
33. 54640-10-7
34. Cas-115-77-5
35. Charmor Pm 15
36. Ccris 2306
37. Hsdb 872
38. Einecs 204-104-9
39. Mfcd00004692
40. Brn 1679274
41. Unii-su420w1s6n
42. Auxenutril
43. Pentaertyhritol
44. Hydrafuca
45. Ai3-19571
46. Hercules Mono-pe
47. Auxitrans (tn)
48. Mono Pentaerythritol
49. 3sy
50. Pentaerythritol, Cp
51. Tetramethylol Methane
52. Pentaerythritol, 98%
53. Pentaerythritol, 99%
54. Monopentaerythrito
55. Pentaerythritol-[13c]
56. Ec 204-104-9
57. Pentaerythritol, Sodium Salt
58. Pentaerythritol [mi]
59. Schembl15049
60. Wln: Q1x1q1q1q
61. 4-01-00-02812 (beilstein Handbook Reference)
62. C(ch2oh)4
63. Pentaerythritol [hsdb]
64. Pentaerythritol [inci]
65. 1, 2,2-bis(hydroxymethyl)-
66. Pentaerythritol [mart.]
67. Chembl3186112
68. Dtxsid2026943
69. Pentaerythritol [who-dd]
70. 1,2-diacylglycerol-ld-pe-pool
71. Nsc8100
72. Chebi:134760
73. Damiana Powder & Powder Extract
74. Zinc391843
75. Methane, Tetrakis(hydroxymethyl)-,
76. Amy40485
77. Pentaerythritol, Calcium, Zinc Salt
78. Tox21_201921
79. Tox21_303573
80. Stl483077
81. Akos009166690
82. Db13526
83. 2,2-bis-hydroxymethyl-propane-1,3-diol
84. Ncgc00249136-01
85. Ncgc00257496-01
86. Ncgc00259470-01
87. Bp-13392
88. 2,2-bis(hydroxymethyl)-propane-1,3-diol
89. Ft-0652275
90. Ft-0673583
91. P0039
92. Black Cohosh Root Powder & Powder Extract
93. D08331
94. A803483
95. Q421828
96. Q-201541
97. Q-201892
98. F0001-0283
Molecular Weight | 136.15 g/mol |
---|---|
Molecular Formula | C5H12O4 |
XLogP3 | -2.4 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 4 |
Exact Mass | 136.07355886 g/mol |
Monoisotopic Mass | 136.07355886 g/mol |
Topological Polar Surface Area | 80.9 Ų |
Heavy Atom Count | 9 |
Formal Charge | 0 |
Complexity | 51.8 |
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 | 1 |
A - Alimentary tract and metabolism
A06 - Drugs for constipation
A06A - Drugs for constipation
A06AD - Osmotically acting laxatives
A06AD14 - Pentaerithrityl
10 mg/kg (14)C-pentaerythrite, administered orally to 12 mice (females), was absorbed and excreted rapidly. Half of the administered dose left the gastrointestinal tract within 15 min and 68% of the dose appeared in the urine and feces after 4 hr. The compound detected was pentaerythrite.
European Commission, ESIS; IUCLID Dataset, Pentaerythritol (115-77-5) p.44 (2000 CD-ROM edition). Available from, as of February 18, 2010: https://esis.jrc.ec.europa.eu/
In ... experiments with (14)carbon pentaerythritol, 69% of (14)carbon was excreted, probably as unchanged compound, in 24 hr urine and 23% in feces /after oral administration to dogs/. Blood levels were greatest after 1 hr.
The Chemical Society. Foreign Compound Metabolism in Mammals. Volume 1: A Review of the Literature Published Between 1960 and 1969. London: The Chemical Society, 1970., p. 42
Kinetics of urinary excretion of pentaerythritol were first order and apparently dose-independent ...
The Chemical Society. Foreign Compound Metabolism in Mammals. Volume 2: A Review of the Literature Published Between 1970 and 1971. London: The Chemical Society, 1972., p. 446
Feeding studies in human volunteers revealed that about 85% of pentaerythritol fed was eliminated unchanged in urine. Elimination was essentially complete in 30 hr.
American Conference of Governmental Industrial Hygienists. Documentation of the TLV's and BEI's with Other World Wide Occupational Exposure Values. CD-ROM Cincinnati, OH 45240-1634 2007.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30522
Submission : 2016-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33942
Submission : 2019-07-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33943
Submission : 2019-07-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34816
Submission : 2020-04-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2797
Submission : 1976-11-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4557
Submission : 1982-05-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5820
Submission : 1985-05-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17131
Submission : 2004-01-19
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1131
Submission : 1968-01-25
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3005
Submission : 1977-08-05
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
A Pentaerythritol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentaerythritol, including repackagers and relabelers. The FDA regulates Pentaerythritol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentaerythritol 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 Pentaerythritol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pentaerythritol supplier is an individual or a company that provides Pentaerythritol active pharmaceutical ingredient (API) or Pentaerythritol finished formulations upon request. The Pentaerythritol suppliers may include Pentaerythritol API manufacturers, exporters, distributors and traders.
click here to find a list of Pentaerythritol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pentaerythritol DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentaerythritol active pharmaceutical ingredient (API) in detail. Different forms of Pentaerythritol DMFs exist exist since differing nations have different regulations, such as Pentaerythritol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentaerythritol DMF submitted to regulatory agencies in the US is known as a USDMF. Pentaerythritol USDMF includes data on Pentaerythritol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentaerythritol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pentaerythritol suppliers with USDMF on PharmaCompass.
Pentaerythritol 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 Pentaerythritol 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 Pentaerythritol GMP manufacturer or Pentaerythritol GMP API supplier for your needs.
A Pentaerythritol CoA (Certificate of Analysis) is a formal document that attests to Pentaerythritol's compliance with Pentaerythritol specifications and serves as a tool for batch-level quality control.
Pentaerythritol CoA mostly includes findings from lab analyses of a specific batch. For each Pentaerythritol 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.
Pentaerythritol may be tested according to a variety of international standards, such as European Pharmacopoeia (Pentaerythritol EP), Pentaerythritol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pentaerythritol USP).
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