Synopsis
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NDC API
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FDA Orange Book
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1. Cetanol
2. Cetyl Alcohol
3. Cetyl Alcohol, 14c-labeled
4. Cetyl Alcohol, Aluminum Salt
5. Hexadecan-1-ol
6. N-hexadecanol
1. Cetyl Alcohol
2. Hexadecan-1-ol
3. 36653-82-4
4. Hexadecanol
5. Cetanol
6. Palmityl Alcohol
7. Hexadecyl Alcohol
8. N-hexadecanol
9. N-1-hexadecanol
10. N-cetyl Alcohol
11. Cetaffine
12. Cetylol
13. Cetal
14. Ethal
15. Ethol
16. Cetylic Alcohol
17. N-hexadecyl Alcohol
18. Loxanwachs Sk
19. Crodacol C
20. Loxanol K Extra
21. 1-hexadecyl Alcohol
22. Elfacos C
23. Loxanol K
24. Crodacol-cas
25. Crodacol-cat
26. Siponol Wax-a
27. Atalco C
28. Cetalol Ca
29. Siponol Cc
30. Lanol C
31. 1-cetanol
32. Hyfatol 16
33. Cachalot C-50
34. Cachalot C-51
35. Cachalot C-52
36. Alcohol C-16
37. Product 308
38. Aldol 54
39. Dytol F-11
40. Adol
41. Palmitic Alcohol
42. Cyclal Cetyl Alcohol
43. Alfol 16
44. Lorol 24
45. Adol 52
46. Adol 54
47. Adol 52 Nf
48. Hyfatol
49. Epal 16nf
50. 1-hexadecyl Alc
51. 16-hexadecanol
52. C16 Alcohol
53. Adol 520
54. N-hexadecan-1-ol
55. Cetylalkohol
56. Isocetyl Alcohol
57. 1-hexanedecanol
58. Fema No. 2554
59. Isohexadecyl Alcohol
60. Cetylalcohol
61. Ssd Rp
62. Normal Primary Hexadecyl Alcohol
63. Co-1670
64. Co-1695
65. Cetyl Alchol
66. Lipocol C
67. Fancol Ca
68. Cetyl Alcohol Nf
69. Crodacol C70
70. Rita Ca
71. 1-hydroxyhexadecane
72. Cetanol (tn)
73. Lanette 16
74. Philcohol 1600
75. Cetyl Alcohol (nf)
76. Cetyl Alcohol [nf]
77. Lorol C16
78. Loroll 24
79. Cachalot C-50 Nf
80. Adol 52nf
81. Alcohols, C14-18
82. Nsc-4194
83. 936jst6jcn
84. 67762-30-5
85. Chebi:16125
86. Nsc4194
87. Ncgc00159368-02
88. Ncgc00159368-05
89. Dsstox_cid_7991
90. Dsstox_rid_78633
91. Dsstox_gsid_27991
92. Hexadecanol (van)
93. Fatty Alcohol(c16)
94. Caswell No. 165d
95. Fema Number 2554
96. Hexadecyl Alcohol, Normal
97. Cas-36653-82-4
98. Hsdb 2643
99. Nsc 4194
100. Einecs 253-149-0
101. Unii-936jst6jcn
102. Epa Pesticide Chemical Code 001508
103. Cetyl Alcohol (hexadecanol)
104. Brn 1748475
105. Hexadecylalcohol
106. Ai3-00755
107. Hexadecanol Nf
108. Alcohol Cetylicus
109. Ceraphyl Ica
110. Crodacol C95nf
111. Dehydag Wax 16
112. Eutanol G16
113. Crodacol C95 Nf
114. Laurex 16
115. Mfcd00004760
116. Alfol 16rd
117. Ssd (salt/mix)
118. Cetanol (jp17)
119. Epal 16
120. Hyfatol 16-95
121. Kalcol 6098
122. Loxiol Vpg 1743
123. 1-hexadecanol, 95%
124. Ssd Rp (salt/mix)
125. Cetanol [jan]
126. Bmse000487
127. Chembl706
128. Michel Xo-150-16
129. Ec 253-149-0
130. Fatty Alcohols(c12-16)
131. 1-hexadecanol, >=99%
132. Cetyl Alcohol [ii]
133. Cetyl Alcohol [mi]
134. Schembl3381
135. Cetyl Alcohol [hsdb]
136. Cetyl Alcohol [inci]
137. 124-29-8
138. 4-01-00-01876 (beilstein Handbook Reference)
139. 1-hexadecanol [fhfi]
140. Cetyl Alcohol [vandf]
141. Cetyl Alcohol [mart.]
142. Cetyl Alcohol [usp-rs]
143. Cetyl Alcohol [who-dd]
144. Cetyl Alcohol [who-ip]
145. Dtxsid4027991
146. Amy6070
147. Cetyl Alcohol, Analytical Standard
148. Cetyl Alcohol, Puriss., 95.0%
149. Hms3652h05
150. Cs-d1348
151. Hy-b1465
152. Zinc8214519
153. Einecs 252-964-9
154. Tox21_111609
155. Tox21_300325
156. Cetyl Alcohol [ep Monograph]
157. Lmfa05000061
158. S4173
159. Stl283943
160. Unii-1800h64066
161. Akos005287456
162. Tox21_111609_1
163. 1-hexadecanol, Reagentplus(r), 99%
164. Ccg-266894
165. Db09494
166. Alcohol Cetylicus [who-ip Latin]
167. Ncgc00159368-03
168. Ncgc00159368-04
169. Ncgc00159368-06
170. Ncgc00254286-01
171. Bs-16666
172. Cetyl Alcohol, Puriss., >=99.0% (gc)
173. Ft-0701357
174. Ft-0707360
175. H0071
176. Sw219201-1
177. Cetyl Alcohol, Saj Special Grade, >=98.0%
178. Cetyl Alcohol, Selectophore(tm), >=99.0%
179. En300-19351
180. 1-hexadecanol, Vetec(tm) Reagent Grade, 94%
181. C00823
182. D00099
183. Ab01566915_01
184. Q161632
185. Sr-01000944409
186. Sr-01000944409-1
187. 1800h64066
188. 810f139f-c57e-4df1-916a-a320ad0daf4d
189. F0001-1047
190. Cetyl Alcohol, European Pharmacopoeia (ep) Reference Standard
191. Cetyl Alcohol, United States Pharmacopeia (usp) Reference Standard
192. Cetyl Alcohol, Pharmaceutical Secondary Standard; Certified Reference Material
| Molecular Weight | 242.44 g/mol |
|---|---|
| Molecular Formula | C16H34O |
| XLogP3 | 7.3 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 1 |
| Rotatable Bond Count | 14 |
| Exact Mass | 242.260965704 g/mol |
| Monoisotopic Mass | 242.260965704 g/mol |
| Topological Polar Surface Area | 20.2 Ų |
| Heavy Atom Count | 17 |
| Formal Charge | 0 |
| Complexity | 123 |
| 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 synthetic surfactant (Exosurf), and its non-surface-active components tyloxapol and cetyl alcohol, can function as antioxidants, and their in vivo instillation is associated with decreased hyperoxic injury in rats.
Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. 3:669
1(?). 1= Practically nontoxic: Probable oral lethal dose (human) above 15 g/kg; more than 1 quart (2.2 lb) for 70 kg person (150 lb).
Gosselin, R.E., R.P. Smith, H.C. Hodge. Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams and Wilkins, 1984., p. II-174
No therapeutic indications in medicinal products. Indicated to be used as an indirect additive in food contact substances, or an ingredient in commercial or cosmetic products.
Cetyl alcohol exhibits skin protect properties against skin irritations caused by bites, rashes and stings. The inhibitory action of cetyl alcohol against the growth of _Mycoplasma gallisepticum_ and _Mycopiasma pneumoniae_ has been reported.
Absorption
Following ingestion at a dose level of 2.0 g/kg in rats, cetyl alcohol was partly absorbed. Administration of 0.2 mg cetyl alcohol in rat by stomach tube indicated good absorption as 63-96 % of radiolabeled cetyl alcohol was detected in the lymph. About 15% of total cetyl alcohol was unchanged during its passage through the mucosal cells of the small intestine but mostly underwent oxidation to palmitic acid. The extent of absorption was reported to be 26% in poultry.
Route of Elimination
Following ingestion at a dose level of 2.0 g/kg in rats, about 20% of the dose was recovered as unchanged molecule in the feces. This may be due to the interconvertibility of fatty acids and alcohols, resulting in the conversion of palmitic acid to cetyl alcohol during its passage through the intestinal mucosal cells into the intestinal lumen. In rats, cetyl Alcohol was also excreted in the urine as conjugated glucuronic acid and as expired carbon dioxide.
Following ingestion at a dose level of 2.0 g/kg bw /in rats/, 1-hexadecanone is partly absorbed and metabolized, about 20% of the dose being recovered unchanged in the feces.
Sheftel, V.O.; Indirect Food Additives and Polymers. Migration and Toxicology. Lewis Publishers, Boca Raton, FL. 2000., p. 486
Following ingestion at a dose level of 2.0 g/kg in rats, cetyl alcohol was partly metabolized to palmitic acid. After administration of 0.2 mg cetyl alcohol in rat by stomach tube, cetyl alcohol was mostly oxidized to palmitic acid and incorporated into triglycerides and phospholipids during its passage through the mucosal cells of the small intestine.
Cetyl alcohol is oxidized in rats to the corresponding fatty acid, palmitic acid.
Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. 6:494
The primary aliphatic alcohols undergo two general reactions in vivo, namely oxidation to carboxylic acids and direct conjugation with glucuronic acid. The first reaction proceeds with the intermediate formation of an aldehyde, and the carboxylic acid from this may be either oxidized completely to carbon dioxide or excreted as such or combined with glucuronic acid as an ester glucuronide. The extent to which as alcohol undergoes the second reaction, i.e. direct conjugation to an ether glucuronide, appears to depend upon the speed of the first reaction, for alcohols which are rapidly oxidized from very little ether glucuronide unless given in high doses.
European Chemicals Bureau; IUCLID Dataset, Cetyl Alcohol (36653-82-4) (2000 CD-ROM edition). Available from, as of April 14, 2006: https://esis.jrc.ec.europa.eu/
Cetyl alcohol has hydrating properties that makes it a suitable emulsifier and stabilizer in pharmaceutical formulations. It is also present in washable ointment base due to its dispersant abilities and stabilizing properties. Potential antimicrobial activity of cetyl alcohol may be due to a change in cell membrane permeability that either blocks absorption of essential nutrients and induction of outward diffusion vital cellular components. This proposed mechanism of action is thought to be similar for other long-chain aliphatic alcohols with same antimicrobial activity, such as myristyl alcohol and behenyl alcohol.
API SUPPLIERS
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9969
Submission : 1992-11-13
Status : Inactive
Type : II
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A Cetyl Alcohol API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetyl Alcohol API, including repackagers and relabelers. The FDA regulates Cetyl Alcohol API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetyl Alcohol API 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 Cetyl Alcohol API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cetyl Alcohol API supplier is an individual or a company that provides Cetyl Alcohol API active pharmaceutical ingredient (API) or Cetyl Alcohol API finished formulations upon request. The Cetyl Alcohol API suppliers may include Cetyl Alcohol API API manufacturers, exporters, distributors and traders.
click here to find a list of Cetyl Alcohol API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cetyl Alcohol API DMF (Drug Master File) is a document detailing the whole manufacturing process of Cetyl Alcohol API active pharmaceutical ingredient (API) in detail. Different forms of Cetyl Alcohol API DMFs exist exist since differing nations have different regulations, such as Cetyl Alcohol API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cetyl Alcohol API DMF submitted to regulatory agencies in the US is known as a USDMF. Cetyl Alcohol API USDMF includes data on Cetyl Alcohol API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cetyl Alcohol API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cetyl Alcohol API suppliers with USDMF on PharmaCompass.
Cetyl Alcohol API 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 Cetyl Alcohol API 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 Cetyl Alcohol API GMP manufacturer or Cetyl Alcohol API GMP API supplier for your needs.
A Cetyl Alcohol API CoA (Certificate of Analysis) is a formal document that attests to Cetyl Alcohol API's compliance with Cetyl Alcohol API specifications and serves as a tool for batch-level quality control.
Cetyl Alcohol API CoA mostly includes findings from lab analyses of a specific batch. For each Cetyl Alcohol API 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.
Cetyl Alcohol API may be tested according to a variety of international standards, such as European Pharmacopoeia (Cetyl Alcohol API EP), Cetyl Alcohol API JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cetyl Alcohol API USP).
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