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1. 1,2 Ethanediol
2. 1,2-ethanediol
3. 2 Hydroxyethanol
4. 2-hydroxyethanol
5. Glycol, Ethylene
6. Glycol, Monoethylene
7. Monoethylene Glycol
1. Ethane-1,2-diol
2. 1,2-ethanediol
3. 107-21-1
4. Glycol
5. Monoethylene Glycol
6. 1,2-dihydroxyethane
7. 2-hydroxyethanol
8. Glycol Alcohol
9. Ethylene Alcohol
10. Polyethylene Glycol
11. Macrogol
12. Fridex
13. Tescol
14. Ethylene Dihydrate
15. Norkool
16. Macrogol 400 Bpc
17. Dowtherm Sr 1
18. Ethanediol
19. Zerex
20. Poly(ethylene Glycol)
21. Ucar 17
22. Lutrol-9
23. Polyethylene Glycol 200
24. Ethyleneglycol
25. Aethylenglykol
26. Ethylenglycol
27. 1,2-ethandiol
28. Polyethylene Glycol 1000
29. 1,2-ethylene Glycol
30. 1,2-dihydroxy Ethane
31. Ethylen Glycol
32. Ethylene-glycol
33. 146ar
34. Polyethylene Glycol 3350
35. Lutrol 9
36. Mfcd00002885
37. Nsc 93876
38. Carbowax 300
39. Peg
40. Hoch2ch2oh
41. Union Carbide Xl 54 Type I De-icing Fluid
42. Peg 1000
43. M.e.g.
44. Fc72kvt52f
45. Dtxsid8020597
46. Chebi:30742
47. 1, 2-ethanediol
48. Nsc-93876
49. Dsstox_cid_597
50. Dsstox_rid_75680
51. Dsstox_gsid_20597
52. Glycol, Ethylene-
53. Glycol, Polyethylene
54. Glycols, Polyethylene
55. Caswell No. 441
56. Aethylenglykol [german]
57. Polyethylene Oxide
58. Carbowax 20
59. Cas-107-21-1
60. Polyethylene Glycols
61. Carbowax 400
62. Carbowax 1000
63. Ccris 3744
64. Dowtherm 4000
65. Hsdb 5012
66. Ethylene Glycol Polymer
67. Nci-c00920
68. Peg 3350
69. Einecs 203-473-3
70. Ethylene Glycol Homopolymer
71. Polyethylene Glycol 6000
72. Unii-fc72kvt52f
73. Epa Pesticide Chemical Code 042203
74. 1,2-ethanediol Homopolymer
75. Wln: Q2q
76. Ethyleneglycole
77. Athylenglykol
78. Ehtylene Glycol
79. Etylene Glycol
80. Ai3-03050
81. 2-ethanediol
82. Polyaethylenglykol
83. Ilexan E
84. 4-vinyl Cathecol
85. Polyaethylenglykole
86. Meg 100
87. Solbanon (tn)
88. 1,2-ethane Diol
89. 1,2-ethane-diol
90. Ethane-1.2-diol
91. Gxt
92. Peg 4000
93. 1,2-ethyleneglycol
94. Ethan-1,2-diol
95. Mono-ethylene Glycol
96. Macrogol 400
97. Carbowax 1540
98. 1,2-ethylene-glycol
99. Lutrol E (tn)
100. Nanosilver+eg
101. Ylene Glycol
102. Dupont Zonyl Fso Fluorinated Surfactants
103. Ethylene Glycol-[d6]
104. Alpha-hydro-omega-hydroxypoly(oxyethylene)
105. Glycol [inci]
106. Polyethylene Glycol-400
107. Macrogol 400 (tn)
108. Polyethylene Oxide (nf)
109. Polyethylene Glycol (nf)
110. Sentry Polyox Wsr (tn)
111. Ethyleneglycol, Reagentplus
112. Macrogol 1500 (tn)
113. Macrogol 4000 (tn)
114. Macrogol 6000 (tn)
115. Ec 203-473-3
116. Lowenol T-163a
117. Macrogol Ointment (jp17)
118. Glycol, Polyethylene(300)
119. Ho(ch2)2oh
120. Nciopen2_001979
121. Nciopen2_002019
122. Nciopen2_002100
123. Macrogol 400 (jp17)
124. Ethylene Glycol [ii]
125. Ethylene Glycol [mi]
126. Polyethylene Glycol 300 Nf
127. Alpha-hydro-omega-hydroxypoly(oxy-1,2-ethanediyl)
128. Ethylene Glycol 5 M Solution
129. Mls002454404
130. Polyethylene Glycol, Diglycidyl Bisphenol A Polymer
131. Bidd:er0283
132. Fisherfresh™ Concentrate
133. Macrogol 1500 (jp17)
134. Macrogol 4000 (jp17)
135. Macrogol 6000 (jp17)
136. Ethylene Glycol [hsdb]
137. Chembl457299
138. Ethylene Glycol [mart.]
139. Ethylene Glycol, Ar, >=99%
140. Ethylene Glycol, Lr, >=99%
141. Macrogol 20000 (jp17)
142. Chebi:46793
143. Ethylene Glycol [usp-rs]
144. Ethylene Glycol [who-dd]
145. Peg1000
146. Hms2267f07
147. Poly(ethylene Glycol) Methyl Ether
148. Polyethylene Glycol 3350 (usp)
149. Ethylene Glycol, P.a., 99.5%
150. Lowenol Copolymer 1985-a
151. Lowenol Copolymer 1985-b
152. 1,2-ethanediol (glycol)
153. Amy22336
154. Nsc32853
155. Nsc32854
156. Nsc57859
157. Nsc93876
158. Peg 3600
159. Peg-1000
160. Poly (ethylene Glycol) Methyl Ether
161. Str01171
162. Zinc5224354
163. Ethylene Glycol, Analytical Standard
164. Tox21_202038
165. Tox21_300637
166. Ethane-1,2-diol (ethylene Glycol)
167. Ethylene Glycol, Anhydrous, 99.8%
168. Nsc-32853
169. Nsc-32854
170. Nsc-57859
171. Nsc152324
172. Nsc152325
173. Nsc155081
174. Polyethylene Glycol 8000, Nf Fcc
175. Stl264188
176. Akos000119039
177. Alpha,omega-hydroxypoly(ethylene Oxide)
178. Nsc-152324
179. Nsc-152325
180. Nsc-155081
181. Ethylene Glycol, Spectrophotometric Grade
182. Ncgc00091510-01
183. Ncgc00091510-02
184. Ncgc00091510-03
185. Ncgc00254292-01
186. Ncgc00259587-01
187. Bp-13454
188. Bp-31056
189. Glycerol Impurity B [ep Impurity]
190. Oxirane, 2,2'-((1-methylethylidene)bis(4,1-phenyleneoxymethylene))bis-, Polymer With Alpha-hydro-omega-hydroxypoly(oxy-1,2-ethanediyl)
191. Smr001262244
192. Dihydrocarveol, (-)-, Mixture Of Isomers
193. Ethylene Glycol High Purity Grd 1l
194. Ethylene Glycol, Reagentplus(r), >=99%
195. Dupont Zonyl Fse Fluorinated Surfactants
196. Ethylene Glycol 100 Microg/ml In Methanol
197. Residual Solvent Class 2 - Ethylene Glycol
198. E0105
199. Ethylene Glycol 1000 Microg/ml In Methanol
200. Ethylene Glycol, Puriss., >=99.5% (gc)
201. Ft-0626292
202. Ft-0692978
203. 1,2-ethane-1,1,2,2-d4-diol-d2(9ci)
204. Ethylene Glycol, Bioultra, >=99.5% (gc)
205. Ethylene Glycol, Saj First Grade, >=99.0%
206. C01380
207. D03370
208. D06418
209. D06419
210. D06420
211. D06421
212. D06422
213. D06423
214. Ethylene Glycol, Jis Special Grade, >=99.5%
215. Ethylene Glycol, Anhydrous, Zero2(tm), 99.8%
216. Ethylene Glycol, Vetec(tm) Reagent Grade, 98%
217. A851234
218. Ethylene Glycol, Spectrophotometric Grade, >=99%
219. Q194207
220. J-001731
221. F0001-0142
222. 004143f9-240e-472f-9d5a-b1b13bba2a18
223. Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-hydroxy-
224. Ethylene Glycol, United States Pharmacopeia (usp) Reference Standard
225. Propylene Glycol Related Compound Ethylene Glycol [usp Impurity]
226. Ethylene Glycol, Pharmaceutical Secondary Standard; Certified Reference Material
227. Ethylene Glycol Solution, Nmr Reference Standard, 80% In Dmso-d6 (99.9 Atom % D), Nmr Tube Size 3 Mm X 8 In.
228. Ethylene Glycol Solution, Nmr Reference Standard, 80% In Dmso-d6 (99.9 Atom % D), Nmr Tube Size 5 Mm X 8 In.
229. Ethylene Glycol;1,2-ethanediol;ethane-1,2-diol;glycolethylene Glycol;ethanediol;ethylene Glycol 1,2-ethanediol Ethane-1,2-diol Glycolethylene Glycol Ethanediol
230. Residual Solvent Class 2 - Ethylene Glycol, United States Pharmacopeia (usp) Reference Standard
| Molecular Weight | 62.07 g/mol |
|---|---|
| Molecular Formula | C2H6O2 |
| XLogP3 | -1.4 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 1 |
| Exact Mass | 62.036779430 g/mol |
| Monoisotopic Mass | 62.036779430 g/mol |
| Topological Polar Surface Area | 40.5 Ų |
| Heavy Atom Count | 4 |
| Formal Charge | 0 |
| Complexity | 6 |
| 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 |
Lethal dose = 1.4 mL/kg (approximately 1.5 g/kg), or 100 mL for adults (70 kg).
inchem - pim
Doses of 1.0 to 2.0 g/kg bw (100 mL) are lethal in humans.
Sheftel, V.O.; Indirect Food Additives and Polymers. Migration and Toxicology. Lewis Publishers, Boca Raton, FL. 2000., p. 726
Polyethylene glycol is indicated for use as an over-the-counter osmotic laxative to relieve occasional constipation. When used in combination with sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride and potassium chloride, it is used for cleansing of the colon in preparation for colonoscopy in adults.
FDA Label
The osmotic effect of PEG produces a copious watery diarrhea. The onset of action of PEG 3350 is about 1 to 2 hours after oral ingestion. The colonic transit of polyethylene glycol occurs in a dose-dependent manner. When used for bowel preparation before colonscopy, electrolytes are typically added in the oral solution to prevent dehydration and electrolyte disturbances. As an over-the-counter laxative, the OTC product does not contain any salts that can be absorbed. In a study involving healthy subjects, PEG 3350 had negligible effects on colonic fluid absorption or with the ability of the colonic mucosa to generate and sustain steep electrochemical gradients.
A - Alimentary tract and metabolism
A06 - Drugs for constipation
A06A - Drugs for constipation
A06AD - Osmotically acting laxatives
A06AD15 - Macrogol
Absorption
Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean Cmax was 2.7 mcg/mL and the mean Tmax was 3 hours. Typically, polyethylene glycols with a high molecular weight are poorly absorbed from the gastrointestinal tract following oral administration.
Route of Elimination
Following administration of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, up to 85% to 99% of the compound was excreted in the feces.
Volume of Distribution
Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean volume of distribution was 48,481 L.
Clearance
There is limited information on the clearance rate of polyethylene glycols.
During 4 hr following iv dose of (14)C-ethylene glycol, urinary excretion of (14)C was more rapid from rats (38%) than from rhesus monkeys (10%), but excretion in expired air was similar (about 5%). Some (14)C entered body carbon pool. Oral dose was also more rapidly excreted by rats.
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. 157
Study of renal clearance of ethylene glycol suggests that glomerular filtration and passive reabsorption are main mechanisms involved in renal excretion of ethylene glycol.
Doull, J., C.D. Klaassen, and M. D. Amdur (eds.). Casarett and Doull's Toxicology. 2nd ed. New York: Macmillan Publishing Co., 1980., p. 481
The proportion of administered (14)C (as ethylene glycol) excreted in urine of rats varied with dosage, being 21% at dose of 0.1 g/kg and 78% at dose of 7.5 g/kg. Distribution of radioactivity 24 hr after administration ...to rats was highest in bones (2-10%); highest in muscle of rabbits (3.4%), although liver contained 1.4 and bone 1.7% of dose.
Patty, F. (ed.). Industrial Hygiene and Toxicology: Volume II: Toxicology. 2nd ed. New York: Interscience Publishers, 1963., p. 1501
A dose-dependent change was observed in disposition of (14)C-labeled ethylene glycol after iv administration of 20, 200, 1000, and 2000 mg/kg to Fischer 344 rats. Part of the dose was expired as carbon dioxide and decreased from 39% at 20 and 200 mg/kg to 26% at 1000 and 2000 mg/kg, while urinary excretion of radiocarbon increased from 35 to 56%. As dose increased from 20 to 2,000 mg/kg increases in urinary (14)C was almost entirely attributable to (14)C-glycolate, which comprised 20% of dose in 24 hrs at two higher dose levels and only 2% at lower doses. Blood clearance of (14)C occurred in initial rapid phase (half-life, 3-5 hr), when plasma comprised predominantly of ethylene glycol, that persisted for 12 hrs at 20 mg/kg and 30 hr at 2000 mg/kg administered iv to Fischer 344 rats.
PMID:7175970 Marshall TC; J Toxicol Environ Health 10 (3): 397-409 (1982)
For more Absorption, Distribution and Excretion (Complete) data for ETHYLENE GLYCOL (16 total), please visit the HSDB record page.
Polyethylene glycol is a metabolically inert laxative that does not undergo intestinal enzymatic degradation or bacterial metabolism.
Multiple metabolites contribute to the toxic effects. Glycolaldehyde and glyoxylate are more toxic than glycolate, although the latter is the only metabolite that accumulates in appreciable amounts, owing to the rate-limiting effect of lactate dehydrogenase or glycolate oxidase. Glyoxylate can be converted to numerous metabolites, the most toxic of which is oxalic acid (oxalate). Oxalate complexes with calcium to form calcium oxalate crystals, which are deposited in various tissues.
MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional 21 st ed. Volume 1. MICROMEDEX Thomson Health Care, Englewood, CO. 2001. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 758
Although oxalate normally is a minor metabolic product of ethylene glycol metabolism, urinary oxalate crystals are a common, but not invariable, feature of ethylene glycol intoxication. There are two forms of urinary calcium oxalate crystals: the octahedral or tent-shaped form of the dihydrate crystals, and the prism or dumbell-shaped monohydrate. The latter form is stable under normal physiologic conditions; the dihydrate form appears only during high urinary calcium and oxalate concentrations, as seen in ethylene glycol poisoning. The dihydrate form can transform into the monohydrate form.
Ellenhorn, M.J., S. Schonwald, G. Ordog, J. Wasserberger. Ellenhorn's Medical Toxicology: Diagnosis and Treatment of Human Poisoning. 2nd ed. Baltimore, MD: Williams and Wilkins, 1997., p. 1153
In oxidative metabolism of ethylene glycol in mammals, species variations occur which explain... differences in toxicity. Glycol is oxidized by major pathway into carbon dioxide, and by minor pathway to ... oxalic acid. Extent of formation of oxalic acid is dependent on dose level, but has ... been shown to vary with species ...
Parke, D. V. The Biochemistry of Foreign Compounds. Oxford: Pergamon Press, 1968., p. 118
Rabbits and rats were given doses of 0.1-2.0 g/kg /of (14)C-ethylene glycol/. Rabbits received the doses orally or by subcutaneous injection, rats were given subcutaneous injections. In rabbits and rats, approximately 20% to 30% of the (14)C label from ethylene glycol (14)C was eliminated in the urine. Metabolites found in the 24-hr urine incl unchanged ethylene glycol (6.0 to 15.1%) and a trace of oxalic acid (0.1%
PMID:13704828 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1205673 Gessner PK et al; Biochem J 79: 482-89 (1961)
For more Metabolism/Metabolites (Complete) data for ETHYLENE GLYCOL (10 total), please visit the HSDB record page.
Following a two-day split-dosing regimen of an oral suspension containing 140 grams of PEG 3350 in healthy subjects, the mean half life was 4.1 hours.
Serum: 2-3 hours; not detectable in urine or tissues after 24-48 hours (metabolites present for longer periods); [TDR, p. 659]
TDR - Ryan RP, Terry CE, Leffingwell SS (eds). Toxicology Desk Reference: The Toxic Exposure and Medical Monitoring Index, 5th Ed. Washington DC: Taylor & Francis, 1999., p. 659
... Ingestion of the 2 alcohols resulted in a peculiar intoxication due to their metabolic interaction. The half-life of ethylene glycol was prolonged to 14 hr.
Divanon F et al; J. Pharm. Clin 16(3): 177-182 (1997)
Hepatic metabolism occurs through successive oxidations by the enzyme alcohol dehydrogenase. The elimination half life of ethylene glycol in the absence of alcohol dehydrogenase inhibitors is 2.5 to 3.0 hours. If alcohol dehydrogenase inhibitor therapy is instituted before the development of renal insufficiency, the elimination half life lengthens to approximately 17 hours, mostly via normal renal elimination. In the presence of fomepizole, the elimination half life is increased to approximately 20 hours.
Dart, R.C. (ed). Medical Toxicology. Third Edition, Lippincott Williams & Wilkins. Philadelphia, PA. 2004., p. 1224
...After iv administration of 20, 200, 1000, and 2000 mg/kg /ethylene glycol/ to Fischer 344 rats. ...Blood clearance of (14)C occurred in initial rapid phase (half-life, 3-5 hr)... .
PMID:7175970 Marshall TC; J Toxicol Environ Health 10 (3): 397-409 (1982)
... Rats /were exposed/ (nose only) to (14)C-ethylene glycol vapor at a concentration of 32 mg/L for 30 min. ...After 6 hr, blood levels declined by apparent first order kinetics with a half life of 53 hr.
Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. V7 9
Plasma half-lives in rodents, monkeys, and dogs (receiving 1-1000 mg/kg body weight) range from 1 to 4 hr.
International Programme on Chemical Safety; Concise International Chemical Assessment Document Number 45 Ethylene Glycol: Human Health Effects (2002). Available from, as of October 6, 2011: https://www.inchem.org/pages/cicads.html
Osmotic laxatives contain substances that are poorly absorbable and draw water into the lumen of the bowel. Polyethylene glycol functions is an osmotic laxative that causes increased water retention in the lumen of the colon by binding to water molecules, thereby producing loose stools.
Ethylene glycol is metabolized by alcohol dehydrogenase to glycoaldehyde, which is then metabolized to glycolic, glyoxylic, and oxalic acids. These acids, along with excess lactic acid are responsible for the anion gap metabolic acidosis. Oxalic acid readily precipitates with calcium to form insoluble calcium oxalate crystals. Tissue injury is caused by widespread deposition of oxalate crystals and the toxic effects of glycolic and glyoxylic acids.
Olson, K.R. (Ed.); Poisoning & Drug Overdose. 5th ed. Lange Medical Books/McGraw-Hill. New York, N.Y. 2007., p. 193
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PharmaCompass offers a list of Polyethylene Glycol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Polyethylene Glycol manufacturer or Polyethylene Glycol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Polyethylene Glycol manufacturer or Polyethylene Glycol supplier.
PharmaCompass also assists you with knowing the Polyethylene Glycol API Price utilized in the formulation of products. Polyethylene Glycol API Price is not always fixed or binding as the Polyethylene Glycol Price is obtained through a variety of data sources. The Polyethylene Glycol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Macrogol 400 (JP16) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Macrogol 400 (JP16), including repackagers and relabelers. The FDA regulates Macrogol 400 (JP16) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Macrogol 400 (JP16) 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 Macrogol 400 (JP16) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Macrogol 400 (JP16) supplier is an individual or a company that provides Macrogol 400 (JP16) active pharmaceutical ingredient (API) or Macrogol 400 (JP16) finished formulations upon request. The Macrogol 400 (JP16) suppliers may include Macrogol 400 (JP16) API manufacturers, exporters, distributors and traders.
click here to find a list of Macrogol 400 (JP16) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Macrogol 400 (JP16) DMF (Drug Master File) is a document detailing the whole manufacturing process of Macrogol 400 (JP16) active pharmaceutical ingredient (API) in detail. Different forms of Macrogol 400 (JP16) DMFs exist exist since differing nations have different regulations, such as Macrogol 400 (JP16) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Macrogol 400 (JP16) DMF submitted to regulatory agencies in the US is known as a USDMF. Macrogol 400 (JP16) USDMF includes data on Macrogol 400 (JP16)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Macrogol 400 (JP16) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Macrogol 400 (JP16) 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 Macrogol 400 (JP16) Drug Master File in Japan (Macrogol 400 (JP16) JDMF) empowers Macrogol 400 (JP16) 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 Macrogol 400 (JP16) JDMF during the approval evaluation for pharmaceutical products. At the time of Macrogol 400 (JP16) 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 Macrogol 400 (JP16) suppliers with JDMF on PharmaCompass.
A Macrogol 400 (JP16) CEP of the European Pharmacopoeia monograph is often referred to as a Macrogol 400 (JP16) Certificate of Suitability (COS). The purpose of a Macrogol 400 (JP16) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Macrogol 400 (JP16) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Macrogol 400 (JP16) to their clients by showing that a Macrogol 400 (JP16) CEP has been issued for it. The manufacturer submits a Macrogol 400 (JP16) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Macrogol 400 (JP16) CEP holder for the record. Additionally, the data presented in the Macrogol 400 (JP16) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Macrogol 400 (JP16) DMF.
A Macrogol 400 (JP16) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Macrogol 400 (JP16) 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 Macrogol 400 (JP16) suppliers with CEP (COS) on PharmaCompass.
Macrogol 400 (JP16) 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 Macrogol 400 (JP16) 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 Macrogol 400 (JP16) GMP manufacturer or Macrogol 400 (JP16) GMP API supplier for your needs.
A Macrogol 400 (JP16) CoA (Certificate of Analysis) is a formal document that attests to Macrogol 400 (JP16)'s compliance with Macrogol 400 (JP16) specifications and serves as a tool for batch-level quality control.
Macrogol 400 (JP16) CoA mostly includes findings from lab analyses of a specific batch. For each Macrogol 400 (JP16) 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.
Macrogol 400 (JP16) may be tested according to a variety of international standards, such as European Pharmacopoeia (Macrogol 400 (JP16) EP), Macrogol 400 (JP16) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Macrogol 400 (JP16) USP).
