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1. 1 Alpha-hydroxycholecalciferol
2. 1 Alpha-hydroxyvitamin D3
3. 1-alpha-oxycholecalciferol
4. 1-hydroxycholecalciferol
5. 1-hydroxycholecalciferol, (1alpha,3alpha-(5z,7e))-isomer
6. 1-hydroxycholecalciferol, (1beta)-(5z)-isomer
7. 1-hydroxycholecalciferol, (1beta,3beta-(5e,7e))-isomer
8. 1-hydroxycholecalciferol, Aluminum Salt
9. 1alpha-ohd3
10. Alfad
11. Alphacalcidol
12. Bondiol
13. Eenalfadrie
14. Einsalpha
15. Etalpha
16. Oksidevit
17. One-alpha
18. Un-alfa
1. 1-hydroxycholecalciferol
2. Alphacalcidol
3. 41294-56-8
4. 1alpha-hydroxyvitamin D3
5. Alfarol
6. Bondiol
7. Einsalpha
8. Etalpha
9. Oxydevit
10. 1-hydroxyvitamin D3
11. 1alpha-hydroxycholecalciferol
12. Alsiodol
13. Alpha-calcidol
14. One-alpha
15. Alfacalcidolum
16. Un-alpha
17. 1alpha-hydroxy-vitamin D3
18. Vitamin D3, 1alpha-hydroxy-
19. Alpharol
20. Tevabone
21. Un Alpha
22. Un Alfa
23. .alpha.-calcidol
24. 1.alpha.-hydroxyvitamin D3
25. 1-alpha-vitamin D
26. 1.alpha.(oh)d3
27. 1-alpha-hydroxy-vitamin D3
28. 1.alpha-hydroxycholecalciferol
29. 1.alpha.-hydroxycholecalciferol
30. (1r,3s,5z)-5-[(2e)-2-[(1r,3as,7ar)-7a-methyl-1-[(2r)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol
31. Chebi:31186
32. (5z,7e)-9,10-seco-5,7,10(19)-cholestatrien-1alpha,3beta-diol
33. Alpha D3
34. 1
35. A-hydroxy-5,6-trans-vitamin D3
36. Urq2517572
37. (1r,3s)-5-[2-[(1r,3as,7ar)-7a-methyl-1-[(2r)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidenecyclohexane-1,3-diol
38. 1alpha-hydroxyvitamin D3 / 1alpha-hydroxycholecalciferol
39. 1alpha-oh-d3
40. 9,10-secocholesta-5,7,10(19)-triene-1alpha,3beta-diol
41. Sinovul
42. (5z,7e)-(1s,3r)-9,10-seco-5,7,10(19)-cholestatriene-1,3-diol
43. Alpha-d3
44. Alpha D 3
45. 1 Alpha-hydroxyvitamin D3
46. Alfacalcidolum [inn-latin]
47. Alfacalcidiol
48. Onealfa
49. Diseon
50. 1-alpha-hydroxycholecalciferol
51. Alfacalcidol [inn:ban:jan]
52. Ccris 3341
53. Unii-urq2517572
54. Alsiodol (tn)
55. Einecs 255-297-1
56. Eb 644
57. 1a-hydroxycholecalciferol, Alfacalcidol
58. 1-hydroxy Vitamin D3
59. 1-alpha-hydroxyvitamin D
60. Alfacalcidol (jan/inn)
61. Udpgatriammoniumsalt
62. Alfacalcidol [inn]
63. Alfacalcidol [jan]
64. 1-alpha-hydroxyvitamin D3
65. Schembl3063
66. Alfacalcidol [mart.]
67. Alfacalcidol [who-dd]
68. Chembl1601669
69. Dtxsid0022569
70. Chebi:94779
71. Alfacalcidol [ep Monograph]
72. 1(alpha)-hydroxyvitamin D3
73. Cs-m0939
74. Ex-a4432
75. Lmst03020231
76. Zinc12484965
77. Akos017343040
78. Cs-0389
79. Db01436
80. Lp-0030
81. 9,10-secocholesta-5,7,10(19)-triene-1,3-diol, (1.alpha.,3.beta.,5z,7e)-
82. Hy-10003
83. Alfacalcidol 100 Microg/ml In Acetonitrile
84. 1.alpha.-hydroxycholecalciferol [mi]
85. 1alpha-hydroxyvitamin D3, >=97.0% (hplc)
86. D01518
87. Q155883
88. Q-200608
89. 9,10-secocholesta-,7,10(19)-triene-1alpha,3beta-diol
90. (1s,3r,5z,7e)-9,10-secocholesta-5,7,10-triene-1,3-diol
91. Alfacalcidol, European Pharmacopoeia (ep) Reference Standard
92. (1alpha,3beta,5z,7e)-secocholesta-5,7,10(19)-triene-1,3-diol
93. (5z,7e)-9,10-secocholesta-5,7,10(19)-triene-1alpha,3beta-diol
94. (1?,3?,5z,7e)-9,10-secocholesta-5,7,10(19)-triene-1,3-diol
95. 9,10-secocholesta-5,7,10(19)-triene-1,3-diol, (1alpha,3beta,5z,7e)-
96. (1alpha,3beta,5z,7e)-9,10-secocholesta-5,7,10(19)-triene-1,3-diol
97. (5z,7e)-9,10-secocholesta-5,7,10(19)-triene-1.alpha.,3.beta.-diol
98. 9,10-secocholesta-5,7,10(19)-triene-1,3-diol, (1-alpha,3-beta,5z,7e)-
99. Alfacalcidol For System Suitability, European Pharmacopoeia (ep) Reference Standard
100. (1r,3s,z)-5-((e)-2-((1r,3as,7ar)-7a-methyl-1-((r)-6-methylheptan-2-yl)hexahydro-1h-inden-4(2h)-ylidene)ethylidene)-4-methylenecyclohexane-1,3-diol
101. 1,3-cyclohexanediol, 5-((2e)-2-((1r,3as,7ar)-1-((1r)-1,5-dimethylhexyl)octahydro-7a-methyl-4h-inden-4-ylidene)ethylidene)-4-methylene-, (1r,3r)-
102. M9b
| Molecular Weight | 400.6 g/mol |
|---|---|
| Molecular Formula | C27H44O2 |
| XLogP3 | 6.8 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 6 |
| Exact Mass | 400.334130642 g/mol |
| Monoisotopic Mass | 400.334130642 g/mol |
| Topological Polar Surface Area | 40.5 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 643 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 6 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 2 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Alfacalcidol is indicated in adult patients with chronic renal failure for the management of hypocalcemia, secondary hyperparathyroidism, or osteodystrophy. Alfacalcidol is indicated in the management of nutritional and malabsorptive rickets and osteomalacia, vitamin D-dependent rickets and osteomalacia, and hypophosphataemic vitamin D resistant rickets and osteomalacia.
FDA Label
Alfacalcidol works to increase serum levels of calcium by stimulating intestinal calcium absorption, reabsorption of calcium from bone, and possibly the renal reabsorption of calcium. It also modestly promotes intestinal phosphorus absorption. In patients with renal failure, alfacalcidol increased intestinal calcium and phosphorus absorption in a dose-related manner. This increase in calcium and phosphorus levels occurs within three days following drug administration: this effect was reversed within three days of drug discontinuation. In patients with chronic renal failure, serum calcium levels were elevated while parathyroid hormone and alkaline phosphatase levels returned to normal levels within five days following alfacalcidol administration. Since alfacalcidol suppresses parathyroid hormone, a reduction in parathyroid hormone levels is achieved more rapidly in patients on intermittent intravenous therapy, with significant reductions occurring within three months of therapy. In patients receiving daily oral therapy of alfacalcidol, the time it takes alfacalcidol to normalize plasma calcium levels may be up to several months, possibly reflecting calcium being utilized for bone mineralization. In patients with nutritional osteomalacia, alfacalcidol increased calcium absorption with six hours of oral administration and the effects peaked at 24 hours.
Bone Density Conservation Agents
Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)
A - Alimentary tract and metabolism
A11 - Vitamins
A11C - Vitamin a and d, incl. combinations of the two
A11CC - Vitamin d and analogues
A11CC03 - Alfacalcidol
Absorption
Alfacalcidol is absorbed passively and almost completely in the small intestine.
Alfacalcidol is rapidly converted in the liver to 1,25-dihydroxyvitamin D, which is essentially the metabolite of vitamin D that regulates calcium and phosphate metabolism. Alfacalcidol is further metabolized to other polar inactive metabolites, excreted primarily through the bile.
The half-life of alfacalcidol ranges from three to four hours.
In conditions like chronic renal failure, renal bone disease, hypoparathyroidism, and vitamin D dependent rickets, the kidneys' capacity for 1-hydroxylation is impaired, leading to reduced production of endogenous 1,25-dihydroxyvitamin D and aberrated mineral metabolism. As an active and potent analog of vitamin D, alfacalcidol works to restore the functions and activities of endogenous 1,25-dihydroxyvitamin D.
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ABOUT THIS PAGE
A Alfacalcidol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alfacalcidol, including repackagers and relabelers. The FDA regulates Alfacalcidol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alfacalcidol 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 Alfacalcidol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alfacalcidol supplier is an individual or a company that provides Alfacalcidol active pharmaceutical ingredient (API) or Alfacalcidol finished formulations upon request. The Alfacalcidol suppliers may include Alfacalcidol API manufacturers, exporters, distributors and traders.
click here to find a list of Alfacalcidol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Alfacalcidol Drug Master File in Japan (Alfacalcidol JDMF) empowers Alfacalcidol 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 Alfacalcidol JDMF during the approval evaluation for pharmaceutical products. At the time of Alfacalcidol 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 Alfacalcidol suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Alfacalcidol Drug Master File in Korea (Alfacalcidol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alfacalcidol. The MFDS reviews the Alfacalcidol KDMF as part of the drug registration process and uses the information provided in the Alfacalcidol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alfacalcidol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Alfacalcidol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alfacalcidol suppliers with KDMF on PharmaCompass.
A Alfacalcidol CEP of the European Pharmacopoeia monograph is often referred to as a Alfacalcidol Certificate of Suitability (COS). The purpose of a Alfacalcidol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alfacalcidol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alfacalcidol to their clients by showing that a Alfacalcidol CEP has been issued for it. The manufacturer submits a Alfacalcidol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alfacalcidol CEP holder for the record. Additionally, the data presented in the Alfacalcidol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alfacalcidol DMF.
A Alfacalcidol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alfacalcidol 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 Alfacalcidol suppliers with CEP (COS) on PharmaCompass.
Alfacalcidol 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 Alfacalcidol 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 Alfacalcidol GMP manufacturer or Alfacalcidol GMP API supplier for your needs.
A Alfacalcidol CoA (Certificate of Analysis) is a formal document that attests to Alfacalcidol's compliance with Alfacalcidol specifications and serves as a tool for batch-level quality control.
Alfacalcidol CoA mostly includes findings from lab analyses of a specific batch. For each Alfacalcidol 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.
Alfacalcidol may be tested according to a variety of international standards, such as European Pharmacopoeia (Alfacalcidol EP), Alfacalcidol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alfacalcidol USP).
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