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1. Aneurin
2. Mononitrate, Thiamine
3. Thiamin
4. Thiamine
5. Thiamine Mononitrate
6. Vitamin B 1
7. Vitamin B1
1. 532-43-4
2. Thiamine Mononitrate
3. Vitamin B1 Nitrate
4. Vitamin B1 Mononitrate
5. Aneurine Mononitrate
6. Betabion Mononitrate
7. Thiamine Nitrate (salt)
8. Thiamin Mononitrate
9. Thiamine Mononitrate [usp]
10. Vitamin B1 (as Thiamine Nitrate)
11. 2-[3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol-3-ium-5-yl]ethanol;nitrate
12. 8k0i04919x
13. Thiazolium, 3-((4-amino-2-methyl-5-pyrimidinyl)methyl)-5-(2-hydroxyethyl)-4-methyl-, Nitrate (salt)
14. Aneurine Nitrate
15. Thiamine Mononitrate (usp)
16. 3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-5-(2-hydroxyethyl)-4-methyl-1,3-thiazol-3-ium Nitrate
17. Thiaminenitrate
18. Vitamin B(sub 1) Nitrate
19. Mononitrato De Tiamina
20. Einecs 208-537-4
21. Thiamin Nitrate
22. Unii-8k0i04919x
23. Thiamini Mononitras
24. Vitanon (tn)
25. Mfcd00036330
26. Thiamine Nitrate, 95%
27. Thiamine Mononitrate,(s)
28. Thiamine Nitrate (jp17)
29. 3-((4-amino-2-methyl-5-pyrimidinyl)methyl)-5-(2-hydroxyethyl)-4-methylthiazolium Nitrate
30. 3-(4-amino-2-methylpyrimidyl-5-methyl)-4-methyl-5,beta-hydroxyethylthiazolium Nitrate
31. Dsstox_cid_18762
32. Dsstox_rid_79391
33. Dsstox_gsid_38762
34. Schembl60971
35. Thiamine Nitrate, Aldrichcpr
36. Thiamine Nitrate [jan]
37. Thiamine Nitrate [inci]
38. Chembl2104496
39. Dtxsid4038762
40. Thiamine Mononitrate [mi]
41. Thiamine Nitrate [mart.]
42. Thiamine Mononitrate [fcc]
43. Hy-b2223
44. Thiamine Mononitrate [vandf]
45. Tox21_302321
46. Thiamine Mononitrate [who-dd]
47. Thiamine Mononitrate [who-ip]
48. Akos015918391
49. Akos015961239
50. Thiamine Nitrate [ep Impurity]
51. Cs-7673
52. Thiamine Mononitrate, >=98% (hplc)
53. Thiamine Nitrate [ep Monograph]
54. Ncgc00255700-01
55. 3-((4-amino-2-methyl-5-pyrimidinyl)methyl)-5-(2-hydroxyethyl)-4-m-ethylthiazolium Nitrate (salt)
56. Ac-13450
57. As-15189
58. Cas-532-43-4
59. Thiamine Nitrate (salt) [who-ip]
60. Thiazolium, 3-((4-amino-2-methyl-5-pyrimidinyl)methyl)-5-(2-hydroxyethyl)-4-m-ethyl-, Nitrate (salt)
61. Thiazolium,3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methyl-,nitrate (salt)
62. Thiamini Mononitras [who-ip Latin]
63. Thiamine Mononitrate [usp Monograph]
64. Ft-0657793
65. T0182
66. 3-((4-amino-2-methylpyrimidin-5-yl)methyl)
67. D03277
68. E78994
69. A829473
70. Q7783874
71. Thiamine Mononitrate 10 Microg/ml In Acetonitrile:water
72. Thiamine Mononitrate, British Pharmacopoeia (bp) Reference Standard
73. Thiamine Nitrate, European Pharmacopoeia (ep) Reference Standard
74. Thiamine Nitrate, Pharmaceutical Secondary Standard; Certified Reference Material
75. 3-((4-amino-2-methylpyrimidin-5-yl)methyl)-5-(2-hydroxyethyl)-4-methylthiazol-3-ium Nitrate
76. Thiazolium, 3-((4-amino-2-methyl-5-pyrimidinyl)methyl)-5-(2-hydroxyethyl)-4-methyl-, Nitrate (1:1)
77. Thiazolium, 3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2hydroxyethyl)-4-m-ethyl-, Nitrate (salt)
Molecular Weight | 327.36 g/mol |
---|---|
Molecular Formula | C12H17N5O4S |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 4 |
Exact Mass | 327.10012521 g/mol |
Monoisotopic Mass | 327.10012521 g/mol |
Topological Polar Surface Area | 167 Ų |
Heavy Atom Count | 22 |
Formal Charge | 0 |
Complexity | 287 |
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 | 2 |
Vitamin B Complex
A group of water-soluble vitamins, some of which are COENZYMES. (See all compounds classified as Vitamin B Complex.)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32731
Submission : 2018-03-28
Status : Active
Type : II
Certificate Number : R1-CEP 1994-006 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2004-10-06
Type : Chemical
Substance Number : 531
Certificate Number : CEP 2018-069 - Rev 02
Status : Valid
Issue Date : 2024-10-22
Type : Chemical
Substance Number : 531
Certificate Number : CEP 2023-035 - Rev 00
Status : Valid
Issue Date : 2024-07-24
Type : Chemical
Substance Number : 531
Certificate Number : R1-CEP 1999-057 - Rev 05
Status : Valid
Issue Date : 2021-04-26
Type : Chemical
Substance Number : 531
Certificate Number : CEP 2011-076 - Rev 03
Status : Valid
Issue Date : 2024-08-08
Type : Chemical
Substance Number : 531
API Imports and Exports
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ABOUT THIS PAGE
A Thiamine Mononitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thiamine Mononitrate, including repackagers and relabelers. The FDA regulates Thiamine Mononitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thiamine Mononitrate 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 Thiamine Mononitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Thiamine Mononitrate supplier is an individual or a company that provides Thiamine Mononitrate active pharmaceutical ingredient (API) or Thiamine Mononitrate finished formulations upon request. The Thiamine Mononitrate suppliers may include Thiamine Mononitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Thiamine Mononitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thiamine Mononitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Thiamine Mononitrate active pharmaceutical ingredient (API) in detail. Different forms of Thiamine Mononitrate DMFs exist exist since differing nations have different regulations, such as Thiamine Mononitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Thiamine Mononitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Thiamine Mononitrate USDMF includes data on Thiamine Mononitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Thiamine Mononitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Thiamine Mononitrate 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 Thiamine Mononitrate Drug Master File in Japan (Thiamine Mononitrate JDMF) empowers Thiamine Mononitrate 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 Thiamine Mononitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Thiamine Mononitrate 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 Thiamine Mononitrate suppliers with JDMF on PharmaCompass.
A Thiamine Mononitrate CEP of the European Pharmacopoeia monograph is often referred to as a Thiamine Mononitrate Certificate of Suitability (COS). The purpose of a Thiamine Mononitrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Thiamine Mononitrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Thiamine Mononitrate to their clients by showing that a Thiamine Mononitrate CEP has been issued for it. The manufacturer submits a Thiamine Mononitrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Thiamine Mononitrate CEP holder for the record. Additionally, the data presented in the Thiamine Mononitrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Thiamine Mononitrate DMF.
A Thiamine Mononitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Thiamine Mononitrate 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 Thiamine Mononitrate suppliers with CEP (COS) on PharmaCompass.
Thiamine Mononitrate 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 Thiamine Mononitrate 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 Thiamine Mononitrate GMP manufacturer or Thiamine Mononitrate GMP API supplier for your needs.
A Thiamine Mononitrate CoA (Certificate of Analysis) is a formal document that attests to Thiamine Mononitrate's compliance with Thiamine Mononitrate specifications and serves as a tool for batch-level quality control.
Thiamine Mononitrate CoA mostly includes findings from lab analyses of a specific batch. For each Thiamine Mononitrate 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.
Thiamine Mononitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Thiamine Mononitrate EP), Thiamine Mononitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Thiamine Mononitrate USP).
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