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Chemistry

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Also known as: L-ascorbic acid, Vitamin c, 50-81-7, L-ascorbate, L(+)-ascorbic acid, Ascorbate
Molecular Formula
C6H8O6
Molecular Weight
176.12  g/mol
InChI Key
CIWBSHSKHKDKBQ-JLAZNSOCSA-N
FDA UNII
PQ6CK8PD0R

Ascorbic Acid
A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.
Ascorbic acid is a Vitamin C.
1 2D Structure

Ascorbic Acid

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R)-2-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxy-2H-furan-5-one
2.1.2 InChI
InChI=1S/C6H8O6/c7-1-2(8)5-3(9)4(10)6(11)12-5/h2,5,7-10H,1H2/t2-,5+/m0/s1
2.1.3 InChI Key
CIWBSHSKHKDKBQ-JLAZNSOCSA-N
2.1.4 Canonical SMILES
C(C(C1C(=C(C(=O)O1)O)O)O)O
2.1.5 Isomeric SMILES
C([C@@H]([C@@H]1C(=C(C(=O)O1)O)O)O)O
2.2 Other Identifiers
2.2.1 UNII
PQ6CK8PD0R
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Acid, Ascorbic

2. Acid, L-ascorbic

3. Ascorbate, Ferrous

4. Ascorbate, Magnesium

5. Ascorbate, Sodium

6. Ascorbic Acid, Monosodium Salt

7. Di-l-ascorbate, Magnesium

8. Ferrous Ascorbate

9. Hybrin

10. L Ascorbic Acid

11. L-ascorbic Acid

12. Magnesium Ascorbate

13. Magnesium Ascorbicum

14. Magnesium Di L Ascorbate

15. Magnesium Di-l-ascorbate

16. Magnorbin

17. Sodium Ascorbate

18. Vitamin C

2.3.2 Depositor-Supplied Synonyms

1. L-ascorbic Acid

2. Vitamin C

3. 50-81-7

4. L-ascorbate

5. L(+)-ascorbic Acid

6. Ascorbate

7. Ascoltin

8. Ascorbicap

9. Cevitamic Acid

10. Cenolate

11. Natrascorb

12. Hybrin

13. Allercorb

14. Ascorbajen

15. Ascorbutina

16. Ascorteal

17. Cescorbat

18. Cetemican

19. Cevitamin

20. Citriscorb

21. Laroscorbine

22. Lemascorb

23. Proscorbin

24. Roscorbic

25. Secorbate

26. Testascorbic

27. Vitacimin

28. Vitamisin

29. Vitascorbol

30. Ascorin

31. Ascorvit

32. Cantaxin

33. Cebicure

34. Cebione

35. Cegiolan

36. Ceglion

37. Celaskon

38. Cemagyl

39. Cenetone

40. Cergona

41. Cetamid

42. Cevatine

43. Cevimin

44. Cevital

45. Cevitan

46. Cevitex

47. Colascor

48. Concemin

49. Redoxon

50. Vicelat

51. Viforcit

52. Viscorin

53. Vitacee

54. Vitacin

55. Adenex

56. Ascorb

57. Cantan

58. Cebid

59. Cebion

60. Cecon

61. Cemill

62. Cereon

63. Cevex

64. Ciamin

65. Cipca

66. Hicee

67. Ribena

68. Vitace

69. Xitix

70. Davitamon C

71. Arco-cee

72. Planavit C

73. Catavin C

74. Ce Lent

75. Liqui-cee

76. Vicomin C

77. Cee-vite

78. Cevi-bid

79. Scorbu-c

80. C-level

81. C-vimin

82. Cetane-caps Td

83. Duoscorb

84. Scorbacid

85. Cewin

86. Antiscorbic Vitamin

87. C-long

88. C-quin

89. C-span

90. Meri-c

91. Cee-caps Td

92. L-lyxoascorbic Acid

93. L-xyloascorbic Acid

94. Cevalin

95. Antiscorbutic Vitamin

96. Cetane-caps Tc

97. 3-oxo-l-gulofuranolactone

98. 3-keto-l-gulofuranolactone

99. Ce-mi-lin

100. Ido-c

101. Natrascorb Injectable

102. Acidum Ascorbicum

103. L-(+)-ascorbic Acid

104. Ce-vi-sol

105. Ferrous Ascorbate

106. Acidum Ascorbinicum

107. Ascor-b.i.d.

108. (r)-5-((s)-1,2-dihydroxyethyl)-3,4-dihydroxyfuran-2(5h)-one

109. Celin

110. Dora-c-500

111. Kyselina Askorbova

112. Cortalex

113. Ferancee

114. Stuartinic

115. Tolfrinic

116. Acido Ascorbico

117. L-threoascorbic Acid

118. Acide Ascorbique

119. L-3-ketothreohexuronic Acid Lactone

120. Chromagen

121. Kyselina Askorbova [czech]

122. Caswell No. 061b

123. Fema No. 2109

124. Acide Ascorbique [inn-french]

125. Acido Ascorbico [inn-spanish]

126. Acidum Ascorbicum [inn-latin]

127. Sodascorbate

128. Ascorbicin

129. Nci-c54808

130. L-threo-hex-2-enonic Acid, Gamma-lactone

131. L-threo-ascorbic Acid

132. 3-oxo-l-gulofuranolactone (enol Form)

133. Ascor

134. Ascorbicum Acidum

135. Ascorbic Acid, L-

136. Cetebe

137. Ascorbin

138. (+)-ascorbic Acid

139. Hex-2-enonic Acid Gamma-lactone, L-threo-

140. Mfcd00064328

141. Iron(ii) Ascorbate

142. Pq6ck8pd0r

143. Component Of E And C-level

144. Component Of Endoglobin Forte

145. Vitamin C (as Ascorbic Acid)

146. Vasc

147. Ins No.300

148. Ascorbicab

149. E-300

150. Chebi:29073

151. Ins-300

152. Ccris 57

153. Nsc-33832

154. Component Of Cortalex

155. Component Of Ferancee

156. Hsdb 818

157. Nsc-218455

158. 6730-29-6

159. Antiscorbutic Factor

160. Ncgc00164357-01

161. E300

162. Ester-c

163. (2r)-2-[(1s)-1,2-dihydroxyethyl]-3,4-dihydroxy-2h-furan-5-one

164. (5r)-5-[(1s)-1,2-dihydroxyethyl]-3,4-dihydroxyfuran-2(5h)-one

165. Dsstox_cid_106

166. Hex-1-enofuranos-3-ulose

167. (5r)-5-[(1s)-1,2-dihydroxyethyl]-3,4-dihydroxy-2,5-dihydrofuran-2-one

168. Iron-ascorbic Acid Complexes

169. L-ascorbic Acid 1000 Microg/ml In Acetonitrile

170. Dsstox_rid_75370

171. Dsstox_gsid_20106

172. Kangbingfeng

173. Chewcee

174. Citrovit

175. Juvamine

176. Ceklin

177. Rovimix C

178. Scorbu C

179. Ascorbinsaeure

180. Parentrovite

181. Cell C

182. Viscorin 100m

183. Ronotec 100

184. Suncoat Vc 40

185. Rontex 100

186. Ascorbicap (tn)

187. Xyloascorbic Acid, L-

188. Ascoltin (tn)

189. [14c]ascorbic Acid

190. Ascorbic Acid [ban:inn:jan]

191. Vitamin C (ascorbic Acid)

192. [14c]-ascorbic Acid

193. Ascorbic Acid (vit C)

194. L-ascorbic Acid, Meets Usp Testing Specifications

195. 2-(1,2-dihydroxyethyl)-4,5-dihydroxyfuran-3-one

196. Einecs 200-066-2

197. Unii-pq6ck8pd0r

198. Nsc 33832

199. Cevitamate

200. L-lyxoascorbate

201. L-xyloascorbate

202. .ascorbinsaure

203. (5r)-5-((1s)-1,2-dihydroxyethyl)-3,4-dihydroxyfuran-2(5h)-one

204. Vitamin B Mixture With Vitamin C

205. 3eka

206. Ester C

207. (+)-ascorbate

208. L(+)-ascorbate

209. L-threo-hex-2-enono-1,4-lactone

210. L-ascorbic Acid, Free Radical Form

211. L-(+)-ascorbate

212. Ascorbic Acid [usp:inn:ban:jan]

213. Ascorbic Acid Mixture With Vitamin B

214. Vitamin C,(s)

215. E 300

216. Ascorbic Acid Dc97sf

217. (2r)-2-[(1s)-1,2-dihydroxyethyl]-4,5-dihydroxyfuran-3-one

218. Prestwick3_000325

219. L-ascorbic Acid, 99%

220. Ascorbic Acid Mixture With Vitamin B Complex

221. Ascor (tn)

222. Schembl785

223. Bmse000182

224. Vitamin C [vandf]

225. Ascorbic Acid [ii]

226. Ascorbic Acid [mi]

227. Schembl4430

228. Ascorbic Acid [fcc]

229. Ascorbic Acid [inn]

230. Ascorbic Acid [jan]

231. L-ascorbic Acid, Fcc, Fg

232. L-ascorbic Acid, Free Acid

233. Ascorbic Acid [fhfi]

234. Ascorbic Acid [hsdb]

235. Ascorbic Acid [inci]

236. Bspbio_000329

237. (r)-5-(1,2-dihydroxy-ethyl)-3,4-dihydroxy-5h-furan-2-one

238. Mls002153776

239. Ascorbic Acid [vandf]

240. Chembl40274

241. L-ascorbic Acid, Cell Culture

242. Ascorbic Acid [mart.]

243. Bpbio1_000363

244. Gtpl4532

245. Gtpl4781

246. L-ascorbic Acid, Reagent Grade

247. Ascorbic Acid [usp-rs]

248. Ascorbic Acid [who-dd]

249. Ascorbic Acid [who-ip]

250. Dtxsid5020106

251. L-ascorbic Acid, >=99.0%

252. Dtxsid50986567

253. Ascorbic Acid (jp17/usp/inn)

254. Hms2096a11

255. Hms2231n16

256. Hms3713a11

257. L-ascorbic Acid Acs Reagent Grade

258. (2r)-2-[(1s)-1,2-dihydroxyethyl]-4,5-dihydroxy-furan-3-one

259. Ascorbic Acid [orange Book]

260. Bcp27915

261. Hy-b0166

262. Tox21_110315

263. Tox21_112104

264. Tox21_202127

265. Tox21_302958

266. Ascorbic Acid [ep Monograph]

267. Gamma-lactone L-threo-hex-2-enonate

268. L-ascorbic Acid, Analytical Standard

269. L-ascorbic Acid, Ar, >=99.5%

270. S3114

271. Ascorbic Acid [usp Monograph]

272. Akos016843589

273. Tox21_112104_1

274. Zinc100006770

275. Zinc100019304

276. Ccg-207946

277. Db00126

278. L-ascorbic Acid, Mixt. With Vitamin B

279. Nsc 218455

280. Acidum Ascorbicum [who-ip Latin]

281. Gamma-lactone L-threo-hex-2-enonic Acid

282. L-ascorbic Acid, Acs Reagent, >=99%

283. Ncgc00091517-01

284. Ncgc00091517-02

285. Ncgc00091517-03

286. Ncgc00091517-06

287. Ncgc00188972-01

288. Ncgc00256504-01

289. Ncgc00259676-01

290. 53262-66-1

291. Bp-12831

292. Smr001233160

293. L-ascorbic Acid, Plant Cell Culture Tested

294. L-ascorbic Acid, Reagent Grade, Crystalline

295. A0537

296. A8158

297. Ab00376923

298. Ascorbic Acid (l-ascorbic Acid; Vitamin C)

299. Sw198791-2

300. L-ascorbic Acid, Bioultra, >=99.5% (rt)

301. L-ascorbic Acid, Tested According To Ph.eur.

302. C 1000

303. C00072

304. D00018

305. E80759

306. L-ascorbic Acid, P.a., Acs Reagent, 99.0%

307. 2,3-dehydro-l-threo-hexono-1,4-lactone

308. Ab00376923_04

309. Ab00376923_05

310. L-ascorbic Acid, Jis Special Grade, >=99.0%

311. L-ascorbic Acid, Vetec(tm) Reagent Grade, 99%

312. L-ascorbic Acid, Bioxtra, >=99.0%, Crystalline

313. Q199678

314. L-ascorbic Acid, Puriss. P.a., >=99.0% (rt)

315. Q27101942

316. 47a605f0-4187-47a8-b0ce-f9e7da1b0076

317. L-ascorbic Acid, P.a., Acs Reagent, Reag. Iso, 99.7%

318. Ascorbic Acid, British Pharmacopoeia (bp) Reference Standard

319. Ascorbic Acid, European Pharmacopoeia (ep) Reference Standard

320. L-ascorbic Acid, Certified Reference Material, Tracecert(r)

321. L-ascorbic Acid, Powder, Cell Culture Tested, Gamma-irradiated

322. 3,4-dihydroxy-5beta-[(s)-1,2-dihydroxyethyl]furan-2(5h)-one

323. Ascorbic Acid, United States Pharmacopeia (usp) Reference Standard

324. (2r)-2-[(1s)-1,2-dihydroxyethyl]-4,5-dihydroxy-2,3-dihydrofuran-3-one

325. 4-((e)-2-[(2-hydroxyethyl)sulfanyl]diazenyl)benzenecarboxylicacid

326. (5r)-5-[(1s)-1,2-dihydroxyethyl]-3,4-dihydroxyfuran-2(5h)-one (non-preferred Name)

327. L-ascorbic Acid Solution, 1.0 Mg/ml In Acetonitrile: Water, Certified Reference Material

328. L-ascorbic Acid, Anhydrous, Free-flowing, Redi-dri(tm), Acs Reagent, >=99%

329. L-ascorbic Acid, Suitable For Cell Culture, Suitable For Plant Cell Culture, >=98%

330. L-ascorbic Acid (vitamin C)-13c6 Solution, 500 Mug/ml In Acetonitrile: Water, Certified Reference Material, Ampule Of 1 Ml

331. L-ascorbic Acid, Puriss. P.a., Acs Reagent, Reag. Iso, Reag. Ph. Eur., 99.7-100.5% (oxidimetric)

332. Valeryl Fentanyl Hydrochloride Solution, 100 Mug/ml In Methanol (as A Free Base), Certified Reference Material, Ampule Of 0.5 Ml

2.4 Create Date
2011-12-26
3 Chemical and Physical Properties
Molecular Weight 176.12 g/mol
Molecular Formula C6H8O6
XLogP3-1.6
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count6
Rotatable Bond Count2
Exact Mass176.03208797 g/mol
Monoisotopic Mass176.03208797 g/mol
Topological Polar Surface Area107 Ų
Heavy Atom Count12
Formal Charge0
Complexity232
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Therapeutic Uses

Antioxidants; Free Radical Scavengers

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


Prophylaxis and treatment of scurvy

Gilman, A. G., L. S. Goodman, and A. Gilman. (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 6th ed. New York: Macmillan Publishing Co., Inc. 1980., p. 1579


Ascorbic acid 100 to 200 mg daily may be given with desferrioxamine in the treatment of patients with thalassemia, to improve the chelating action of desferrioxamine, thereby increasing the excretion of iron.

Sweetman SC (ed), Martindale: The Complete Drug Reference. London: Pharmaceutical Press (2009), p.1985.


In iron deficiency states ascorbic acid may increase gastrointestinal iron absorption and ascorbic acid or ascorbate salts are therefore included in some oral iron preparations.

Sweetman SC (ed), Martindale: The Complete Drug Reference. London: Pharmaceutical Press (2009), p.1985.


For more Therapeutic Uses (Complete) data for L-Ascorbic Acid (30 total), please visit the HSDB record page.


4.2 Drug Warning

Large doses are reported to cause diarrhea and other gastrointestinal disturbances. It has also been stated that large doses may result in hyperoxaluria and the formation of renal calcium oxalate calculi, and ascorbic acid should therefore be given with care to patients with hyperoxaluria. Tolerance may be induced with prolonged use of large doses, resulting in symptoms of deficiency when intake is reduced to normal. Prolonged or excessive use of chewable vitamin C preparations may cause erosion of tooth enamel.

Sweetman SC (ed), Martindale: The Complete Drug Reference. London: Pharmaceutical Press (2009), p.1984.


Large doses of ascorbic acid have resulted in hemolysis in patients with G6PD deficiency.

Sweetman SC (ed), Martindale: The Complete Drug Reference. London: Pharmaceutical Press (2009), p.1984.


Vitamin C intakes of 250 mg/day or higher have been associated with false-negative results for detecting stool and gastric occult blood. Therefore, high dose vitamin C supplements should be discontinued at least two weeks before physical exams to avoid interference with blood and urine tests.

Otten JJ, Hellwig JP, Meyers LD, eds; Dietary Reference Intakes: The Essential Guide to Nutrient Requirements, Washington, DC: The National Academies Press, 2006, p.208


Supplemental vitamin C may reduce the effectiveness of cancer chemotherapy, and its effectiveness in reducing risk from cancer and related death is unclear.

PDR Network, LLC. PDR for Nonprescription Drugs, Dietary Supplements, and Herbs. 31st Ed. PDR Network, LLC, Montvale, NJ. 2010 p. 603


For more Drug Warnings (Complete) data for L-Ascorbic Acid (25 total), please visit the HSDB record page.


4.3 Minimum/Potential Fatal Human Dose

1(?) = Practically non-toxic: probable oral lethal dose (human) above 15 g/kg, more than 1 qt for 70 kg person (150 lb). Human poisonings are unknown and even reliable estimates of lethal dose in animals are rare.

Gosselin, R.E., R.P. Smith, H.C. Hodge. Clinical Toxicology of Commercial Products. 5th ed. Baltimore: Williams and Wilkins, 1984., p. II-266


4.4 Drug Indication

Used to treat vitamin C deficiency, scurvy, delayed wound and bone healing, urine acidification, and in general as an antioxidant. It has also been suggested to be an effective antiviral agent.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Ascorbic Acid (vitamin C) is a water-soluble vitamin indicated for the prevention and treatment of scurvy, as ascorbic acid deficiency results in scurvy. Collagenous structures are primarily affected, and lesions develop in bones and blood vessels. Administration of ascorbic acid completely reverses the symptoms of ascorbic acid deficiency.


5.2 MeSH Pharmacological Classification

Antioxidants

Naturally occurring or synthetic substances that inhibit or retard oxidation reactions. They counteract the damaging effects of oxidation in animal tissues. (See all compounds classified as Antioxidants.)


Vitamins

Organic substances that are required in small amounts for maintenance and growth, but which cannot be manufactured by the human body. (See all compounds classified as Vitamins.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
ASCORBIC ACID
5.3.2 FDA UNII
PQ6CK8PD0R
5.3.3 Pharmacological Classes
Vitamin C [EPC]; Ascorbic Acid [CS]
5.4 ATC Code

A - Alimentary tract and metabolism

A11 - Vitamins

A11G - Ascorbic acid (vitamin c), incl. combinations

A11GA - Ascorbic acid (vitamin c), plain

A11GA01 - Ascorbic acid (vit C)


B - Blood and blood forming organs

B03 - Antianemic preparations

B03A - Iron preparations

B03AA - Iron bivalent, oral preparations

B03AA10 - Ferrous ascorbate


G - Genito urinary system and sex hormones

G01 - Gynecological antiinfectives and antiseptics

G01A - Antiinfectives and antiseptics, excl. combinations with corticosteroids

G01AD - Organic acids

G01AD03 - Ascorbic acid


S - Sensory organs

S01 - Ophthalmologicals

S01X - Other ophthalmologicals

S01XA - Other ophthalmologicals

S01XA15 - Ascorbic acid


5.5 Absorption, Distribution and Excretion

Absorption

70% to 90%


Ascorbic acid is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. Plasma concentrations of ascorbic acid rise as the dose ingested is increased until a plateau is reached with doses of about 90 to 150 mg daily. Body stores of ascorbic acid in health are about 1.5 g although more may be stored at intakes above 200 mg daily. The concentration is higher in leucocytes and platelets than in erythrocytes and plasma. In deficiency states the concentration in leucocytes declines later and at a slower rate, and has been considered to be a better criterion for the evaluation of deficiency than the concentration in plasma.

Sweetman SC (ed), Martindale: The Complete Drug Reference. London: Pharmaceutical Press (2009), p.1984.


Ascorbic acid is reversibly oxidized to dehydroascorbic acid; some is metabolized to ascorbate-2-sulfate, which is inactive, and oxalic acid which are excreted in the urine. Ascorbic acid in excess of the body's needs is also rapidly eliminated unchanged in the urine; this generally occurs with intakes exceeding 100 mg daily.

Sweetman SC (ed), Martindale: The Complete Drug Reference. London: Pharmaceutical Press (2009), p.1984.


Ascorbic acid crosses the placenta and is distributed into breast milk. It is removed by hemodialysis.

Sweetman SC (ed), Martindale: The Complete Drug Reference. London: Pharmaceutical Press (2009), p.1984.


The renal threshold for ascorbic acid is approx 14 ug/mL, but this level varies among individuals. When the body is saturated with ascorbic acid and blood concentrations exceed the threshold, unchanged ascorbic acid is excreted in the urine. When tissue saturation and blood concentrations of ascorbic acid are low, administration of the vitamin results in little or no urinary excretion of ascorbic acid. Inactive metabolites of ascorbic acid such as ascorbic acid-2-sulfate and oxalic acid are excreted in the urine ... Ascorbic acid is also excreted in the bile but there is no evidence for enterohepatic circulation ...

IPCS; Poisons Information Monograph 046: Ascorbic acid (2006). Available from, as of March 9, 2010: https://www.inchem.org/pages/pims.html


For more Absorption, Distribution and Excretion (Complete) data for L-Ascorbic Acid (29 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Hepatic. Ascorbic acid is reversibly oxidised (by removal of the hydrogen from the enediol group of ascorbic acid) to dehydroascorbic acid. The two forms found in body fluids are physiologically active. Some ascorbic acid is metabolized to inactive compounds including ascorbic acid-2-sulfate and oxalic acid.


Ascorbic acid-2-sulfate has ... been identified as metabolite of Vitamin C in human urine.

Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1548


Ascorbate is oxidized to CO2 in rats and guinea pigs, but considerably less conversion can be detected in man. One route of metabolism of the vitamin in man involves its conversion to oxalate and eventual excretion in the urine; dehydroascorbate is presumably an intermediate.

Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1548


... Young male guinea pigs /were fed/ diets containing either 2 g/kg (18 control animals) or 86 g/kg (29 treatment animals) of ascorbic acid for 275 days. The average weight gain was significantly higher in the control group. Eight control and eight treatment animals, chosen to maintain comparable weights between the groups, were then given a totally deficient ascorbic acid diet 24 hr before a metabolic study was initiated. In the metabolic study, (14)C-labeled L-ascorbic acid (628 g) was then injected intraperitoneally into both treatment and control guinea pigs to study the catabolism and excretion of the ascorbic acid. Catabolism of the labeled ascorbic acid to respiratory (14)CO2 was increased in treatment guinea pigs. The control and treatment animals were then divided into two groups. One group received 3 mg/kg ascorbic acid (chronic deficiency) for 68 days. The other received a diet devoid of ascorbic acid (acute deficiency) for 44 days. Four control and three treatment animals from the chronic deficiency group and three control and four treatment animals from the acute deficiency group were given a totally deficient ascorbic acid diet 24 hr before a second metabolic study was initiated. (14)C-labeled L-ascorbic acid (628 g) was injected intraperitoneally as above. Treatment animals in the chronic deficiency and the acute deficiency groups had increased catabolism of the labeled ascorbic acid to respiratory (14)CO2 compared to control animals in the chronic and acute deficiency groups. The amount of radioactivity recovered in the urine and feces was similar for both groups except for an increased urinary excretion of the label in treated animals exposed to the totally deficient diet. The treatment animals maintained higher tissue stores of ascorbic acid than the control animals. However, this difference was significant only in the testes. When subjected to a totally deficient diet the treatment animals were depleted of ascorbic acid at a faster rate than the control animals. The accelerated catabolism was not reversible by subnormal intakes of the vitamin ...

Cosmetic Ingredient Review Expert Panel; Int J Toxicol 24 (Suppl 2): 51-111 (2005).


... Hartley guinea pigs approximately 30 days pregnant /were divided/ into a control group receiving 25 mg ascorbic acid and a treated group receiving 300 mg/kg/day ascorbic acid daily. All animals were fed a 0.05% ascorbic acid diet. The groups were maintained for 10 days on their respective diets. Pups (both sexes) were randomly chosen on either day 5 or day 10 for the metabolic study. L-l-(14)C-Ascorbic Acid (10 uCi/mM) was injected intraperitoneally into the pups and they were placed in a metabolic chamber for five hours to collect expired (14)CO2. From day 11 all pups were caged individually and weaned to a diet containing only traces of ascorbic acid. Every third day the animals were examined for physical signs of scurvy. Once signs appeared, the animals were examined daily until death. Necropsies were performed on all animals. Pups from the treated group demonstrated a marked increase in (14)CO2 excretion following the intraperitoneal injection. Signs of scurvy appeared 4 days earlier in the treated group and mortality of the treated pups occurred approximately one week earlier. When excretion of labeled CO2 in both groups was correlated with the day of onset of scurvy signs, a linear correlation was found between the two parameters, suggesting that the earlier appearance of signs of scurvy on the experimental pups is secondary to an increased rate of ascorbic acid catabolism ...

Cosmetic Ingredient Review Expert Panel; Int J Toxicol 24 (Suppl 2): 51-111 (2005).


For more Metabolism/Metabolites (Complete) data for L-Ascorbic Acid (10 total), please visit the HSDB record page.


Ascorbic acid has known human metabolites that include Ascorbic acid-2-sulfate.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Biological Half-Life

16 days (3.4 hours in people who have excess levels of vitamin C)


The plasma half-life is reported to be 16 days in humans. This is different in people who have excess levels of vitamin C where the half-life is 3.4 hours

IPCS; Poisons Information Monograph 046: Ascorbic acid (2006). Available from, as of March 9, 2010: https://www.inchem.org/pages/pims.html


Vitamin C has a 96 hr half-life in guinea pigs.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 651


Due to homeostatic regulation, the biological half-life of ascorbate varies widely from 8 to 40 days and is inversely related to the ascorbate body pool.

NAS, Food and Nutrition Board, Institute of Medicine; Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids. National Academy Press, Washington, D.C., pg. 100, 2000. Available from, as of March 4, 2010: https://www.nap.edu/catalog/9810.html


5.8 Mechanism of Action

In humans, an exogenous source of ascorbic acid is required for collagen formation and tissue repair by acting as a cofactor in the posttranslational formation of 4-hydroxyproline in -Xaa-Pro-Gly- sequences in collagens and other proteins. Ascorbic acid is reversibly oxidized to dehydroascorbic acid in the body. These two forms of the vitamin are believed to be important in oxidation-reduction reactions. The vitamin is involved in tyrosine metabolism, conversion of folic acid to folinic acid, carbohydrate metabolism, synthesis of lipids and proteins, iron metabolism, resistance to infections, and cellular respiration.


Ascorbic Acid reducing potential and conversion to AFR (ascorbate free radical) are key to its biological activity, including its free radical scavenging and its relationship to the oxidation of transition metals such as iron and copper at enzyme active sites and in food.

Cosmetic Ingredient Review Expert Panel; Int J Toxicol 24 (Suppl 2): 51-111 (2005).


Vitamin C is known to be an electron donor for eight human enzymes. Three participate in collagen hydroxylation; two in carnitine biosynthesis; and three in hormone and amino acid biosynthesis. The three enzymes that participate in hormone and amino acid biosynthesis are dopamine-beta-hydroxylase, necessary for the biosynthesis of the catecholamines norepinephrine and epinephrine; peptidyl-glycine monooxygenase, necessary for amidation of peptide hormones; and 4-hydroxyphenylpyruvatedioxygenase, involved in tyrosine metabolism. Ascorbate's action with these enzymes involves either monooxygenase or dioxygenase activities.

NAS, Food and Nutrition Board, Institute of Medicine; Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids. National Academy Press, Washington, D.C., pg. 96-97, 2000. Available from, as of March 4, 2010: https://www.nap.edu/catalog/9810.html


As a cofactor for hydroxylase and oxygenase metalloenzymes, ascorbic acid is believed to work by reducing the active metal site, resulting in reactivation of the metal-enzyme complex, or by acting as a co-substrate involved in the reduction of molecular oxygen. The best known of these reactions is the posttranslational hydroxylation of peptide-bound proline and lysine residues during formation of mature collagen. In these reactions, ascorbate is believed to reactivate the enzymes by reducing the metal sites of prolyl (iron) and lysyl (copper) hydroxylases.

NAS, Food and Nutrition Board, Institute of Medicine; Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids. National Academy Press, Washington, D.C., pg. 97-98, 2000. Available from, as of March 4, 2010: https://www.nap.edu/catalog/9810.html


Evidence also suggests that ascorbate plays a role in or influences collagen gene expression, cellular procollagen secretion, and the biosynthesis of other connective tissue components besides collagen, including elastin, fibronectin, proteoglycans, bone matrix, and elastin-associated fibrillin. The primary physical symptoms of ascorbic acid's clinical deficiency disease, scurvy, which involves deterioration of elastic tissue, illustrate the important role of ascorbate in connective tissue synthesis.

NAS, Food and Nutrition Board, Institute of Medicine; Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids. National Academy Press, Washington, D.C., pg. 98, 2000. Available from, as of March 4, 2010: https://www.nap.edu/catalog/9810.html


For more Mechanism of Action (Complete) data for L-Ascorbic Acid (11 total), please visit the HSDB record page.


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K3, 11TH CROSS STREET","city":"","supplier":"CSPC WEISHENG PHARMACEUTICAL (SHIJIAZHUANG) COLTD","supplierCountry":"CHINA","foreign_port":"QINGDAO PT","customer":"KEMIN INDUSTRIES","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"4.2","totalValueFC":"42693.5","currency":"N\/A","unitRateINR":"371.3","date":"19-Feb-2025","totalValueINR":"3712800","totalValueInUsd":"42693.5","indian_port":"Madras Sea","hs_no":"29362700","bill_no":"8441846","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO PT","supplierAddress":"NO. 898 ZHONGSHAN EAST ROAD, HIGH-TECH, INDUSTRIAL DEVELOPMENT ZONE, SHIJIAZHUANG, HEBEI PROVINCE, CHINA","customerAddress":"PLOT NO. K3, 11TH CROSS STREET"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740508200,"product":"COS-VCE (VITAMIN C DERIVATIVE) (INCI NAME : 3-O-ETHYL ASCORBIC ACID)COS-VCE (VITAMIN C DERIVATIVE) (INCI NAME : 3-O-ETHYL ASCORB","address":"ACKRUTI CENTRE POINT, 301, 3RD FL.","city":"MUMBAI MAHARASHTRA","supplier":"COSMOL CO., LTD. (GEON MIN. 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(18608) Hwaseong - 18608, Gyeonggido, Kore Korea, Republic of","customerAddress":"ACKRUTI CENTRE POINT, 301, 3RD FL."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740681000,"product":"VITAMIN C (ASCORBIC ACID) BP\/IP\/USP\/EP VITAMIN C (ASCORBIC ACID) BP\/IP\/USP\/EP","address":"103, PROSPECT CHAMBERS, 317\/321,","city":"MUMBAI, MAHARASHTRA","supplier":"LUWEI PHARMACEUTICAL GROUP CO., LTD.","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"NANDLAL BANKATLAL PRIVATE LIMITED","customerCountry":"INDIA","quantity":"23000.00","actualQuantity":"23000","unit":"KGS","unitRateFc":"3","totalValueFC":"69623.6","currency":"N\/A","unitRateINR":"263.3","date":"28-Feb-2025","totalValueINR":"6054750","totalValueInUsd":"69623.6","indian_port":"JNPT","hs_no":"29362700","bill_no":"8617701","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"Shuangfeng Industrial Park, Zichuan District, Zibo City, Shandong, Chi na China","customerAddress":"103, PROSPECT CHAMBERS, 317\/321,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740940200,"product":"ASCORBIC ACID COATED IH TYPE EC ASCORBIC ACID COATED IH TYPE EC","address":"NO.49D, BOMMASANDRA INDUSTRIAL","city":"BANGALORE","supplier":"ROYAL DSM","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"ADCOCK INGRAM","customerCountry":"INDIA","quantity":"24.00","actualQuantity":"24","unit":"KGS","unitRateFc":"104","totalValueFC":"2528.6","currency":"USD","unitRateINR":"9126","date":"03-Mar-2025","totalValueINR":"219024","totalValueInUsd":"2528.6","indian_port":"Bangalore Air","hs_no":"29362700","bill_no":"8660420","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ZURICH","supplierAddress":"30, 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PARLE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742236200,"product":"3-O-ETHYL ASCORBIC ACID ACTIBISO-VCE (COSMETIC INGREDIENT FOR MANUFACTURING OF ANTI AGEING CREAM APPLICATION)(COSMETIC GRADE) (EFFECTIVE FOR ANTI-AGEING AND ANTI-WRINKLE","address":"Flat No. C\/UH-527 In Tower-C Urban Homes Shahpur Bamheta","city":"GHAZIABAD","supplier":"SUZHOU SUNLAND PHARMATECH CO.LTD.","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SG GREEN TECH HEALTH & BEAUTY","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"95.2","totalValueFC":"9654.9","currency":"USD","unitRateINR":"8362.8","date":"18-Mar-2025","totalValueINR":"836282.19","totalValueInUsd":"9654.9","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"8948439","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 608, 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OFFICE: NO. 16\/2,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742409000,"product":"50184-ASCORBIC ACID (VITAMIN C) PEPSI GRADE 1250112044\/11531150184-ASCORBIC ACID (VITAMIN C) PEPSI GRADE 1250112044\/11531","address":"3B, DLF CORPORATE PARK, S-BLOCK,","city":"GURGAON","supplier":"PRINOVA EUROPE LTD.","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"PEPSICO INDIA HOLDINGS ","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"3.3","totalValueFC":"3345","currency":"USD","unitRateINR":"289.7","date":"20-Mar-2025","totalValueINR":"289740","totalValueInUsd":"3345","indian_port":"JNPT","hs_no":"29362700","bill_no":"8992023","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"10 ALDERSGATE STREET LONDON, EC1A 4 HJ UNITED KINGDOM , , United Kingdo m United Kingdom","customerAddress":"3B, DLF CORPORATE PARK, S-BLOCK,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742754600,"product":"SODIUM ASCORBATE CRYSTALLINE SODIUM ASCORBATE CRYSTALLINE","address":"UNIT NO.T-8B 5TH FLR, PHOENIX HOUS","city":"S B MARG LOWER PAREL,MAHARASHTRA","supplier":"ROYAL DSM","supplierCountry":"UNITED KINGDOM","foreign_port":"ANTWERPEN","customer":"OMNIACTIVE HEALTH TECHNOLOGIES LIMITED","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"34.4","totalValueFC":"17325.4","currency":"N\/A","unitRateINR":"3001.4","date":"24-Mar-2025","totalValueINR":"1500687","totalValueInUsd":"17325.4","indian_port":"JNPT","hs_no":"29362700","bill_no":"9068769","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Crystalline","supplierPort":"ANTWERPEN","supplierAddress":"30 PASIR PANJANG ROAD, # 13-31, MAP LETREE BUSINESS CITY Singapore - 11 7440, , Singapore Singapore","customerAddress":"UNIT NO.T-8B 5TH FLR, PHOENIX HOUS"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743186600,"product":"ASCORBIC ACID IP ASCORBIC ACID IP","address":"42,MAHANT ROAD,3,VILE PARLE","city":"MUMBAI,MAHARASHTRA","supplier":"SINOBRIGHT PHARMACEUTICAL COMPANY LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"PRATISTHA PHARMA","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"2.6","totalValueFC":"26204.8","currency":"USD","unitRateINR":"227","date":"29-Mar-2025","totalValueINR":"2269800","totalValueInUsd":"26204.8","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29362700","bill_no":"9189439","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PT","supplierAddress":"OFFICE F,32\/F,PLAZA 88,NO.88 YEUNG UK ROAD, TSUEN WAN NT, HONG KONG SDNF CHINA","customerAddress":"42,MAHANT ROAD,3,VILE PARLE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743186600,"product":"SPECWHITE VCE (3-O-ETHYL ASCORBIC ACID) SPECWHITE VCE (3-O-ETHYL ASCORBIC ACID)","address":"8A 2ND FLOOR RA BUILDING,NEW NO72","city":"EGMORE,TAMIL NADU","supplier":"SPEC CHEM INDUSTRY INC","supplierCountry":"CHINA","foreign_port":"NANJING","customer":"SCOPE SPECIALITIES LLP","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"76.1","totalValueFC":"38327.7","currency":"N\/A","unitRateINR":"6639.7","date":"29-Mar-2025","totalValueINR":"3319855.35","totalValueInUsd":"38327.7","indian_port":"Bombay Air","hs_no":"29362700","bill_no":"9186098","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANJING","supplierAddress":"NO.689, HUZHOU ROAD, DAWANG STREET ZHONGXIN SUCHU HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE,CHUZHOU CITY,ANHU CHINA","customerAddress":"8A 2ND FLOOR RA BUILDING,NEW NO72"}]
02-Jan-2021
29-Mar-2025
KGS
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL...DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

USFDA APPLICATION NUMBER - 18920

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DOSAGE - SOLUTION;INTRAVENOUS - 25,000MG/50ML...DOSAGE - SOLUTION;INTRAVENOUS - 25,000MG/50ML (500MG/ML)

USFDA APPLICATION NUMBER - 209112

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DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

USFDA APPLICATION NUMBER - 21163

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DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML

USFDA APPLICATION NUMBER - 21163

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DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;...DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL

USFDA APPLICATION NUMBER - 21625

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DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006...DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

USFDA APPLICATION NUMBER - 8809

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ABOUT THIS PAGE

Looking for 50-81-7 / Ascorbic Acid API manufacturers, exporters & distributors?

Ascorbic Acid manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Ascorbic Acid 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 Ascorbic Acid manufacturer or Ascorbic Acid supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ascorbic Acid manufacturer or Ascorbic Acid supplier.

PharmaCompass also assists you with knowing the Ascorbic Acid API Price utilized in the formulation of products. Ascorbic Acid API Price is not always fixed or binding as the Ascorbic Acid Price is obtained through a variety of data sources. The Ascorbic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Ascorbic Acid

Synonyms

L-ascorbic acid, Vitamin c, 50-81-7, L-ascorbate, L(+)-ascorbic acid, Ascorbate

Cas Number

50-81-7

Unique Ingredient Identifier (UNII)

PQ6CK8PD0R

About Ascorbic Acid

A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.

Cevalin Manufacturers

A Cevalin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cevalin, including repackagers and relabelers. The FDA regulates Cevalin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cevalin 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 Cevalin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Cevalin Suppliers

A Cevalin supplier is an individual or a company that provides Cevalin active pharmaceutical ingredient (API) or Cevalin finished formulations upon request. The Cevalin suppliers may include Cevalin API manufacturers, exporters, distributors and traders.

click here to find a list of Cevalin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Cevalin USDMF

A Cevalin DMF (Drug Master File) is a document detailing the whole manufacturing process of Cevalin active pharmaceutical ingredient (API) in detail. Different forms of Cevalin DMFs exist exist since differing nations have different regulations, such as Cevalin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Cevalin DMF submitted to regulatory agencies in the US is known as a USDMF. Cevalin USDMF includes data on Cevalin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cevalin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Cevalin suppliers with USDMF on PharmaCompass.

Cevalin JDMF

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 Cevalin Drug Master File in Japan (Cevalin JDMF) empowers Cevalin 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 Cevalin JDMF during the approval evaluation for pharmaceutical products. At the time of Cevalin 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 Cevalin suppliers with JDMF on PharmaCompass.

Cevalin KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Cevalin Drug Master File in Korea (Cevalin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cevalin. The MFDS reviews the Cevalin KDMF as part of the drug registration process and uses the information provided in the Cevalin KDMF to evaluate the safety and efficacy of the drug.

After submitting a Cevalin 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 Cevalin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Cevalin suppliers with KDMF on PharmaCompass.

Cevalin CEP

A Cevalin CEP of the European Pharmacopoeia monograph is often referred to as a Cevalin Certificate of Suitability (COS). The purpose of a Cevalin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cevalin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cevalin to their clients by showing that a Cevalin CEP has been issued for it. The manufacturer submits a Cevalin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cevalin CEP holder for the record. Additionally, the data presented in the Cevalin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cevalin DMF.

A Cevalin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cevalin 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 Cevalin suppliers with CEP (COS) on PharmaCompass.

Cevalin WC

A Cevalin written confirmation (Cevalin WC) is an official document issued by a regulatory agency to a Cevalin manufacturer, verifying that the manufacturing facility of a Cevalin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cevalin APIs or Cevalin finished pharmaceutical products to another nation, regulatory agencies frequently require a Cevalin WC (written confirmation) as part of the regulatory process.

click here to find a list of Cevalin suppliers with Written Confirmation (WC) on PharmaCompass.

Cevalin NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Cevalin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cevalin API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Cevalin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Cevalin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cevalin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Cevalin suppliers with NDC on PharmaCompass.

Cevalin GMP

Cevalin 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 Cevalin 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 Cevalin GMP manufacturer or Cevalin GMP API supplier for your needs.

Cevalin CoA

A Cevalin CoA (Certificate of Analysis) is a formal document that attests to Cevalin's compliance with Cevalin specifications and serves as a tool for batch-level quality control.

Cevalin CoA mostly includes findings from lab analyses of a specific batch. For each Cevalin 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.

Cevalin may be tested according to a variety of international standards, such as European Pharmacopoeia (Cevalin EP), Cevalin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cevalin USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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