Synopsis
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JDMF
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EU WC
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NDC API
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Europe
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Canada
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1. Cyclohexaamylose
2. Cyclomaltohexaose
1. 10016-20-3
2. Alfadex
3. Cyclohexapentylose
4. Alpha-dextrin
5. Cyclomaltohexaose
6. Alpha-schardinger Dextrin
7. Cyclohexaamylose
8. Cyclomaltohexose
9. .alpha.-cyclodextrin
10. Alpha Cyclodextrin
11. Alpha-cycloamylose
12. A-cyclodextrin
13. Oristar Acd
14. Ringdex-a
15. Cavamax W6
16. Cavamax W 6 Food
17. Nsc 269470
18. Celdex A 100
19. Ins No.457
20. Z1lh97ktrm
21. Alpha-cyclodextrin (cyclohexa-amylose)
22. Dexy Pearl .alpha.-100
23. Nsc-269470
24. Ins-457
25. Cyclohexaamylose Carbonate
26. Chebi:40585
27. Ncgc00090767-02
28. E-457
29. Mfcd00078207
30. Dsstox_cid_10698
31. Dsstox_rid_78856
32. Dsstox_gsid_30698
33. Alfadex [inn]
34. Dextrin, Alpha-cyclo
35. Alfadexum
36. Alfadexum [inn-latin]
37. Acx
38. Cas-10016-20-3
39. Einecs 233-007-4
40. Unii-z1lh97ktrm
41. Alfadex [inn:ban:nf]
42. Nsc269470
43. 2zym
44. 3zst
45. 4fem
46. Alpha -cyclodextrin
47. Isoquinoliniumchloride
48. Alfadex (inn/nf)
49. 3ck7
50. Alfadex [ii]
51. Alfadex [mart.]
52. Alfadex [who-dd]
53. Ec 233-007-4
54. Schembl24981
55. Alpha-cyclodextrin, >=98%
56. Mls001074882
57. Alfadex [ep Monograph]
58. Alpha-cyclodextrin [fcc]
59. Chembl1230813
60. Dtxsid7030698
61. Hexakis(hydroxymethyl)[?]dodecol
62. Hms2232k21
63. .alpha.-cyclodextrin [mi]
64. Alpha Cyclodextrin [usp-rs]
65. Hy-b1513
66. Tox21_111015
67. Tox21_201252
68. Tox21_300302
69. Akos015900446
70. Zinc242498445
71. Db01909
72. Ncgc00090767-01
73. Ncgc00090767-03
74. Ncgc00090767-04
75. Ncgc00253988-01
76. Ncgc00258804-01
77. As-10392
78. Bp-31069
79. Smr000568406
80. Cs-0013302
81. Alpha-cyclodextrin, Purum, >=98.0% (hplc)
82. C-9100
83. D08846
84. I11498
85. A897566
86. Q27104460
87. Alfadex, European Pharmacopoeia (ep) Reference Standard
88. Alpha Cyclodextrin, United States Pharmacopeia (usp) Reference Standard
89. Alpha-cyclodextrin, Powder, Bioreagent, Suitable For Cell Culture, >=98%
90. Alpha-cyclodextrin, Produced By Wacker Chemie Ag, Burghausen, Germany, >=99.0% (hplc)
91. Alpha-cyclodextrin, Fg, Produced By Wacker Chemie Ag, Burghausen, Germany, Food, >=98% (on Dry Substance)
92. Alpha-cyclodextrin, Produced By Wacker Chemie Ag, Burghausen, Germany, Life Science, 98.0-101.0% Cyclodextrin Basis (hplc)
93. Anti-configured Tubular 2-((2-ethoxy-13,113,513-tris(2-ethoxy-2-oxoethoxy)-8-hydroxy-116h,516h-3,7-diaza-1(4,12)-8,16-methanodinaphtho[2,1-d:1',2'-g][1,3]dioxocina-5(4,12)-dinaphtho[2,1-d:1',2'-g][1,3]dioxocinacyclooctaphane-2,7-dien-53-yl)oxy)acetic Acid
94. Wurcs=2.0/1,6,6/[a2122h-1a_1-5]/1-1-1-1-1-1/a1-f4_a4-b1_b4-c1_c4-d1_d4-e1_e4-f1
Molecular Weight | 972.8 g/mol |
---|---|
Molecular Formula | C36H60O30 |
XLogP3 | -12.9 |
Hydrogen Bond Donor Count | 18 |
Hydrogen Bond Acceptor Count | 30 |
Rotatable Bond Count | 6 |
Exact Mass | 972.31694049 g/mol |
Monoisotopic Mass | 972.31694049 g/mol |
Topological Polar Surface Area | 475 Ų |
Heavy Atom Count | 66 |
Formal Charge | 0 |
Complexity | 1250 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 30 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14960
Submission : 2000-07-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14960
Submission : 2000-07-25
Status : Active
Type : II
Market Place
Reply
19 Aug 2022
Reply
27 Jan 2020
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
A Alpha-Cyclodextrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alpha-Cyclodextrin, including repackagers and relabelers. The FDA regulates Alpha-Cyclodextrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alpha-Cyclodextrin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Alpha-Cyclodextrin supplier is an individual or a company that provides Alpha-Cyclodextrin active pharmaceutical ingredient (API) or Alpha-Cyclodextrin finished formulations upon request. The Alpha-Cyclodextrin suppliers may include Alpha-Cyclodextrin API manufacturers, exporters, distributors and traders.
click here to find a list of Alpha-Cyclodextrin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alpha-Cyclodextrin DMF (Drug Master File) is a document detailing the whole manufacturing process of Alpha-Cyclodextrin active pharmaceutical ingredient (API) in detail. Different forms of Alpha-Cyclodextrin DMFs exist exist since differing nations have different regulations, such as Alpha-Cyclodextrin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alpha-Cyclodextrin DMF submitted to regulatory agencies in the US is known as a USDMF. Alpha-Cyclodextrin USDMF includes data on Alpha-Cyclodextrin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alpha-Cyclodextrin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alpha-Cyclodextrin suppliers with USDMF on PharmaCompass.
Alpha-Cyclodextrin 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 Alpha-Cyclodextrin 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 Alpha-Cyclodextrin GMP manufacturer or Alpha-Cyclodextrin GMP API supplier for your needs.
A Alpha-Cyclodextrin CoA (Certificate of Analysis) is a formal document that attests to Alpha-Cyclodextrin's compliance with Alpha-Cyclodextrin specifications and serves as a tool for batch-level quality control.
Alpha-Cyclodextrin CoA mostly includes findings from lab analyses of a specific batch. For each Alpha-Cyclodextrin 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.
Alpha-Cyclodextrin may be tested according to a variety of international standards, such as European Pharmacopoeia (Alpha-Cyclodextrin EP), Alpha-Cyclodextrin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alpha-Cyclodextrin USP).
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