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Sorbitol API

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Chemistry

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Also known as: D-sorbitol, D-glucitol, 50-70-4, Glucitol, L-gulitol, (-)-sorbitol

Molecular Formula

C₆H₁₄O₆

Molecular Weight

182.17 g/mol

InChI Key

FBPFZTCFMRRESA-JGWLITMVSA-N

FDA UNII

506T60A25R

A polyhydric alcohol with about half the sweetness of sucrose. Sorbitol occurs naturally and is also produced synthetically from glucose. It was formerly used as a diuretic and may still be used as a laxative and in irrigating solutions for some surgical procedures. It is also used in many manufacturing processes, as a pharmaceutical aid, and in several research applications.

1 2D Structure

Sorbitol API

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2R,3R,4R,5S)-hexane-1,2,3,4,5,6-hexol

2.1.2 InChI

InChI=1S/C6H14O6/c7-1-3(9)5(11)6(12)4(10)2-8/h3-12H,1-2H2/t3-,4+,5-,6-/m1/s1

2.1.3 InChI Key

FBPFZTCFMRRESA-JGWLITMVSA-N

2.1.4 Canonical SMILES

C(C(C(C(C(CO)O)O)O)O)O

2.1.5 Isomeric SMILES

C([C@H]([C@H]([C@@H]([C@H](CO)O)O)O)O)O

2.2 Other Identifiers

2.2.1 UNII

506T60A25R

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Glucitol

2. Klysma Sorbit

3. Medevac

4. Sorbilax

5. Yal

2.3.2 Depositor-Supplied Synonyms

1. D-sorbitol

2. D-glucitol

3. 50-70-4

4. Glucitol

5. L-gulitol

6. (-)-sorbitol

7. Glucarine

8. Diakarmon

9. Multitol

10. Sorbilande

11. Sorbostyl

12. D-(-)-sorbitol

13. Esasorb

14. Neosorb

15. Nivitin

16. Siosan

17. Sorbite

18. Sorbol

19. Cholaxine

20. Sionit

21. Sionite

22. Sionon

23. Sorbo

24. Karion Instant

25. Sorbitol F

26. Sorbex Rp

27. Sorbitol Fp

28. D-sorbol

29. Sionit K

30. Sorbex M

31. Sorbex R

32. Sorbex S

33. Sorbex X

34. Sorbitol Syrup C

35. Hexahydric Alcohol

36. Sorbicolan

37. Sorvilande

38. Gulitol

39. (2r,3r,4r,5s)-hexane-1,2,3,4,5,6-hexaol

40. Neosorb P 60

41. D-sorbite

42. Foodol D 70

43. Sorbitol Solutions

44. Neosorb 20/60dc

45. Neosorb 70/02

46. Neosorb 70/70

47. Glucitol, D-

48. Neosorb P 20/60

49. Karion

50. D-sorbit

51. Karion (carbohydrate)

52. Fema No. 3029

53. Probilagol

54. (2r,3r,4r,5s)-hexane-1,2,3,4,5,6-hexol

55. D-1,2,3,4,5,6-hexanehexol

56. Ccris 1898

57. G-ol

58. Neosorb P 60w

59. Ai3-19424

60. Hsdb 801

61. Iso-sorbide

62. D-glucitol Syrup

63. Glc-ol

64. Nsc 25944

65. Sorbitol (e420)

66. Chebi:17924

67. D-glucitol, Homopolymer

68. Ins No.420(i)

69. Ins-420(i)

70. Resulax

71. Sorbilax

72. 1,2,3,4,5,6-hexanehexol

73. E 420

74. E-420(i)

75. Nsc-25944

76. 506t60a25r

77. 7b5697n

78. D-sorbit 1000 Microg/ml In Methanol

79. E420

80. Medevac

81. Dsstox_cid_3588

82. Dsstox_rid_77095

83. Dsstox_gsid_23588

84. Sorbitur

85. (2s,3r,4r,5r)-hexane-1,2,3,4,5,6-hexol

86. 26566-34-7

87. Sorbit Dp

88. Cas-50-70-4

89. 123236-29-3

90. Smr000112219

91. Sorbitol [usp:nf]

92. Sorbitol 3% In Plastic Container

93. Wurcs=2.0/1,1,0/[h2122h]/1/

94. Einecs 200-061-5

95. Mfcd00004708

96. Solbitol

97. Sorbitol 3.3% In Plastic Container

98. Sorbitol S

99. Dtxsid5023588

100. Sorbitol Fk

101. Unii-506t60a25r

102. Sorbit D-powder

103. Sorbit S

104. Sorbit W-powder

105. Sorbit Wp

106. Sorbitol (nf)

107. Neosorb P60

108. Sorbitol F Solution

109. Kyowa Powder 50m

110. Sorbogem 712

111. Sorbitol (glucitol)

112. Sorbit D 70

113. Sorbit Dp 50

114. Sorbit L 70

115. Sorbit T 70

116. Sorbit W 70

117. D-sorbitol, 99%

118. Sorbit W-powder 50

119. D-[2-2h]glucitol

120. D-sorbitol; D-glucitol

121. D-sorbitol (jp17)

122. Sorbitol [hsdb]

123. Sorbitol [inci]

124. Sorbitol [fcc]

125. Sorbitol [usp]

126. Sorbitol [ii]

127. Sorbitol [mi]

128. Sorbitol [vandf]

129. Sorbitol Solution (usp)

130. D-sorbitol, >=98%

131. D-sorbitol [jan]

132. Schembl763

133. Sorbit Kyowa Powder 50m

134. Sorbitol [mart.]

135. Bmse000115

136. Bmse000803

137. Bmse001007

138. D-sorbitol [fhfi]

139. Epitope Id:114708

140. Sorbitol [usp-rs]

141. Sorbitol [who-dd]

142. Isomalt Impurity, Sorbitol-

143. D-sorbitol, Nf/fcc Grade

144. Chembl1682

145. Mls001333209

146. Mls001333210

147. Sorbitol [orange Book]

148. D-sorbitol, Analytical Standard

149. D-sorbitol, For Electrophoresis

150. Sorbitol [ep Monograph]

151. D-sorbitol, Bioxtra, >=98%

152. D-sorbitol, For Synthesis, 99%

153. Hms2094k21

154. Hms2270a18

155. Pharmakon1600-01300028

156. Hy-b0400

157. Tox21_201937

158. Tox21_303388

159. D-sorbitol, >=98%, Fcc, Fg

160. Nsc759608

161. S2393

162. Zinc18279893

163. Akos015899604

164. D-sorbitol, Plant Cell Culture Tested

165. Ccg-229392

166. Db01638

167. Nsc-759608

168. Sorbitol 3% In Plastic Container (tn)

169. D-sorbitol Solution, 70% In H2o, Cp

170. Isomalt Impurity C [ep Impurity]

171. Ncgc00164353-01

172. Ncgc00164353-02

173. Ncgc00164353-03

174. Ncgc00257447-01

175. Ncgc00259486-01

176. Ac-13186

177. Cs-13177

178. Maltitol Impurity A [ep Impurity]

179. D-sorbitol, Saj First Grade, >=97.0%

180. Sbi-0206688.p002

181. Sorbitol-mannitol Component Sorbitol

182. D-sorbitol, For Molecular Biology, >=98%

183. D-sorbitol, Bioultra, >=99.5% (hplc)

184. D-sorbitol, Saj Special Grade, >=99.0%

185. D-sorbitol, Vetec(tm) Reagent Grade, 97%

186. E-420

187. S0065

188. Sw220289-1

189. D-sorbitol, Crystallized, >=99.0% (hplc)

190. Sorbitol Component Of Sorbitol-mannitol

191. A15606

192. C00794

193. D00096

194. E70384

195. Ab00919085_06

196. D-sorbitol, Liquid, Tested According To Ph.eur.

197. Isomalt Impurity, Sorbitol- [usp Impurity]

198. Q245280

199. 5-(4-methoxyphenyl)-1,3-oxazole-4-carboxylicacid

200. Lactitol Monohydrate Impurity E [ep Impurity]

201. Mixed With Ethyl Acetate Fraction Of Plinia Cauliflora

202. Mixed With Tannin Enriched Fraction Of Plinia Cauliflora

203. Sorbitol, European Pharmacopoeia (ep) Reference Standard

204. 75de42c3-7c3b-4802-95e0-463f02268bdc

205. Sorbitol, United States Pharmacopeia (usp) Reference Standard

206. D-sorbitol, Bioreagent, Cell Culture Tested, Plant Cell Culture Tested

207. Sorbitol, Pharmaceutical Secondary Standard; Certified Reference Material

208. Sorbitol F Solution, 70 Wt. % In H2o, Contains Mainly D-sorbitol With Lesser Amounts Of Other Hydrogenated Oligosaccharides

2.4 Create Date

2004-09-16

3 Chemical and Physical Properties

Molecular Formula	C₆H₁₄O₆
Molecular Weight	182.17 g/mol
XLogP3	-3.1
Hydrogen Bond Donor Count	6
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	5
Exact Mass	182.07903816 g/mol
Monoisotopic Mass	182.07903816 g/mol
Topological Polar Surface Area	121 Å²
Heavy Atom Count	12
Formal Charge	0
Complexity	105
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Therapeutic Uses

Cathartics; Diuretics, Osmotic; Indicators and Reagents; Pharmaceutic Aids

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

National Library of Medicine; 2010 MeSH MeSH Descriptor Data for Sorbitol. Available from, as of March 27, 2010: https://www.nlm.nih.gov/cgi/mesh/2010/MB_cgi?term=Sorbitol

The objective of this report is to describe a cost-effective strategy for management of constipation in nursing home residents with dementia. ... A prospective observational quality improvement study of 41 residents with chronic constipation and receiving an osmotic laxative /was conducted/. Sorbitol was substituted for lactulose. ... The number and amount of laxative use over a period of 4 weeks that were required to maintain regular bowel function was measured. . RESULTS: There was no difference in efficacy of lactulose and sorbitol. Use of additional laxatives was infrequent ... .

Volicer L et al; J Am Med Directors Assoc 6 (3 Supp): 32-4 (2005). Available from, as of March 27, 2010: https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15890292

Osmotic diuretic given iv in 50% (wt/vol) solution to diminish edema, to lower cerebrospinal pressure, or to reduce intraocular pressure in glaucoma ... Dose: 50 to 100 mL of 50% solution; as laxative, oral, 30-50 g. /Former use/

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1235

For more Therapeutic Uses (Complete) data for D-Sorbitol (8 total), please visit the HSDB record page.

4.2 Drug Warning

It is not to be injected. /Sorbitol solution USP/

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1235

The administration of a cathartic alone has no role in the management of the poisoned patient and is not recommended as a method of gut decontamination. Experimental data are conflicting regarding the use of cathartics in combination with activated charcoal. No clinical studies have been published to investigate the ability of a cathartic, with or without activated charcoal, to reduce the bioavailability of drugs or to improve the outcome of poisoned patients. Based on available data, the routine use of a cathartic in combination with activated charcoal is not endorsed. If a cathartic is used, it should be limited to a single dose in order to minimize adverse effects.

PMID:9482428 Barceloux D et al; J Toxicol Clin Toxicol 7: 743-52 (1997).

Side effects occur rarely following rectal administration of glycerin or sorbitol ... Rectal discomfort, irritation, burning or griping, cramping pain, and tenesmus /(straining)/. Hyperemia of rectal mucosa with minimal amounts of hemorrhage and mucus discharge ... occur less frequently following rectal administration of sorbitol.

American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 56:12

Diarrhea frequently occurs with dosages of sorbitol used as adjuncts to sodium polystyrene sulfonate therapy.

American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 56:12

For more Drug Warnings (Complete) data for D-Sorbitol (15 total), please visit the HSDB record page.

4.3 Drug Indication

Used as a non-stimulant laxative via an oral suspension or enema.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Indicators and Reagents

Substances used for the detection, identification, analysis, etc. of chemical, biological, or pathologic processes or conditions. Indicators are substances that change in physical appearance, e.g., color, at or approaching the endpoint of a chemical titration, e.g., on the passage between acidity and alkalinity. Reagents are substances used for the detection or determination of another substance by chemical or microscopical means, especially analysis. Types of reagents are precipitants, solvents, oxidizers, reducers, fluxes, and colorimetric reagents. (From Grant and Hackh's Chemical Dictionary, 5th ed, p301, p499) (See all compounds classified as Indicators and Reagents.)

Cathartics

Agents that are used to stimulate evacuation of the bowels. (See all compounds classified as Cathartics.)

Sweetening Agents

Substances that sweeten food, beverages, medications, etc., such as sugar, saccharine or other low-calorie synthetic products. (From Random House Unabridged Dictionary, 2d ed) (See all compounds classified as Sweetening Agents.)

5.2 ATC Code

A06AD18

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

A - Alimentary tract and metabolism

A06 - Drugs for constipation

A06A - Drugs for constipation

A06AD - Osmotically acting laxatives

A06AD18 - Sorbitol

A - Alimentary tract and metabolism

A06 - Drugs for constipation

A06A - Drugs for constipation

A06AG - Enemas

A06AG07 - Sorbitol

B - Blood and blood forming organs

B05 - Blood substitutes and perfusion solutions

B05C - Irrigating solutions

B05CX - Other irrigating solutions

B05CX02 - Sorbitol

V - Various

V04 - Diagnostic agents

V04C - Other diagnostic agents

V04CC - Tests for bile duct patency

V04CC01 - Sorbitol

5.3 Absorption, Distribution and Excretion

Route of Elimination

Sorbitol will either be excreted in the urine by the kidneys, or metabolized to carbon dioxide and dextrose.

The amounts of sorbitol (SOR) excreted in 24-hr urine were determined on two groups, ie, diabetic and nondiabetic patients, using an improved method in which ion exchange resin column processing was applied, and these levels were compared with SOR levels in whole blood. Urinary SOR concentration was also determined in diabetic and normal rats in the same manner and its relationship to aldose reductase (AR) activity in whole blood was investigated. Changes in SOR levels in urine and whole blood were compared in diabetic rats after administration of an AR inhibitor (ARI). Whole blood SOR levels and urinary SOR excretion were significantly higher in diabetic patients than in nondiabetic patients. The same results were obtained in the animal models. In diabetic rats, the urinary SOR excretion was about five times higher than that in control rats, and the AR activity in whole blood was also significantly higher. The increase in urinary SOR excretion and whole blood SOR levels, as well as AR activity, in blood in the diabetic state was inhibited by ARI administration. The influence of the diabetic state and the efficacy of the ARI were more marked in urinary SOR excretion than in whole blood SOR levels. These data indicate that determinations of urinary SOR excretion and AR activity are easily measurable and of benefit to assessing the diabetic condition.

Nakano I et al; J Diabet Complic 17 (6): 337-42 (2003). Available from, as of March 27, 2010: https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14583178

An accelerated polyol pathway in diabetes contributes to the development of diabetic complications. To elucidate diabetic nephropathy involving also renal tubular damage, ...urinary sorbitol concentrations /were measured/ concomitantly with urinary N-acetyl-D-glucosaminidase (NAG) excretion in WBN-kob diabetic rats.Twenty-four-hour urinary sorbitol concentrations increased in the diabetic rats in parallel with whole blood sorbitol concentrations. An increase in 24-h urinary NAG excretion coincided with the elevated urinary sorbitol levels in the diabetic rats. The administration of epalrestat, an aldose reductase inhibitor, reduced the increased whole blood and urinary sorbitol concentrations and urinary NAG excretion concomitantly with renal aldose reductase inhibition in the diabetic rats. These results indicate that diabetic nephropathy involves distorted cell function of renal tubules, and that treatment with epalrestat may prevent at least the progress of the nephropathy.

Tsugawa T et al; J Endocrinol 181 (3): 429-35 (2004). Available from, as of March 27, 2010: https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15171691

The purpose of this study was to determine whether sorbitol concentration is elevated in the cerebrospinal fluid (CSF) of non-medically ill patients with mood disorders. Lumbar punctures were performed on 30 subjects - 10 with bipolar mood disorder, 10 with unipolar mood disorder, and 10 age-matched normal controls, and CSF sorbitol concentrations were measured, using a gas chromatographic-mass spectroscopic technique. The mean+/-standard deviation of CSF sorbitol concentrations differed among the three groups as follows: bipolar (22.9+/-4.6 umoles/L) > unipolar (19.0+/-2.8 umoles/L)>normal control (15. 6+/-1.9 umoles/L). One-way ANOVA showed significant (P=0.0002) differences among the three groups. Post-hoc tests indicated a significant (P<0.05) difference between bipolars and normal controls, bipolars and unipolars, and unipolars and normal controls...

Regenold WT et al; Psychoneuroendocrinology 25 (6): 593-606 (2000). Available from, as of March 27, 2010: https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10840171

Streptozocin (Str) diabetic rats were obtained by Str iv (35 mg/kg). Glycemia and sorbitol levels from sciatic nerve and lens were measured after 1 d, 2, 5, and 8 months of diabetes. Sorbitol concentrations in serum, heart, diaphragm, small intestine, and kidney after 8 months of diabetes were measured. RESULTS: Diabetic rats after Str injection showed hyperglycemia (> 1.7 g.L-1), hyperphagia, polyuria, polydipsia, and loss of body weight. Sorbitol levels in lens and sciatic nerve increased in normal and diabetic rats; the increase was higher in diabetic rats. No relationship was shown between glycemia and sorbitol levels. An increased sorbitol level after 8 months of diabetes was found in small intestine and kidney...

Ferraz M et al; Acta Pharmacol Sinica 18 (4): 309-11 (1997). Available from, as of March 27, 2010: https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10072911

For more Absorption, Distribution and Excretion (Complete) data for D-Sorbitol (8 total), please visit the HSDB record page.

5.4 Metabolism/Metabolites

Sorbitol is widely used in a number of pharmaceutical products and occurs naturally in many edible fruits and berries. It is absorbed more slowly from the gastrointestinal tract than sucrose and is metabolized in the liver to fructose and glucose ... Sorbitol is better tolerated by diabetics than sucrose and is widely used in many sugar-free liquid vehicles ...

Rowe, R.C., Sheskey, P.J., Quinn, M.E.; (Eds.), Handbook of Pharmaceutical Excipients 6th edition Pharmaceutical Press, London, England 2009, p. 681

70% of orally ingested sorbitol is converted to carbon dioxide without appearing as glucose in the blood ...

O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Whitehouse Station, NJ: Merck and Co., Inc., 2006., p. 1498

5.5 Mechanism of Action

Sorbitol exerts its laxative effect by drawing water into the large intestine, thereby stimulating bowel movements.

... Sorbitol exerts hygroscopic and/or local irritant action, drawing water from tissues into feces and reflexly stimulating evacuation.

American Hospital Formulary Service. Volumes I and II. Washington, DC: American Society of Hospital Pharmacists, to 1984., p. 56:12

The polyol pathway consists of two enzymes aldose reductase (AR) and sorbitol dehydrogenase (SDH); the former is the first enzyme in the polyol pathway, that catalyzes the reduction of glucose to sorbitol, the latter is the second one, that converts sorbitol to fructose using by NAD(+) as a cofactor. ... SDH activity, the second step in the polyol pathway, might make a greater contribution to the etiology of diabetic retinopathy than does the first step involving AR. /This paper proposes/ a novel hypothesis that polymorphisms of SDH gene may be correlated with SDH gene expression levels in diabetic retinas, thus being a valuable genetic marker for diabetic retinopathy.

Amano S et al; Med Hypothesis 60 (4): 550-1 (2003). Available from, as of March 27, 2010: https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12615520

It has been reported that sorbitol induces apoptosis in several cancer cell lines. ... In /this/ study, the intracellular signaling pathways of sorbitol-induced apoptosis in human K562 cells were investigated using both morphological analysis and DNA fragmentation technique. In this study, we demonstrated that sorbitol-induced apoptosis in human K562 cells is a concentration- and time-dependent manner. This sorbitol-induced apoptosis in human K562 cells was also accompanied by the up-regulation of Bax, and down-regulation of p-Bcl-2, but no effect on the levels of Bcl-X(L). Moreover, the sorbitol treatment resulted in a significant reduction of mitochondria membrane potential, increase in the release of mitochondrial cytochrome c (cyt c), and activation of caspase 3. Furthermore, treatment with caspase 3 inhibitor (z-DEVD-fmk) was capable of preventing the sorbitol-induced caspase 3 activity and cell death. These results clearly demonstrate that the induction of apoptosis by sorbitol involves multiple cellular/molecular pathways and strongly suggest that pro- and anti-apoptotic Bcl-2 family proteins, mitochondrial membrane potential, mitochondrial cyt c, and caspase 3, they all participate in sorbitol-induced apoptotic process in human K562 cells.

Marfe G et al; Arch Toxicol 82 (6): 371-7 (2008). Available from, as of March 27, 2010: https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=18046541

Chronic diabetic complications, in particular, nephropathy, peripheral and autonomic neuropathy, "diabetic foot," retinopathy, and cardiovascular disease, remain the major cause of morbidity and mortality in patients with diabetes mellitus. Growing evidence indicates that both increased activity of the sorbitol pathway of glucose metabolism and enhanced oxidative stress are the leading factors in the pathogenesis of diabetic complications. The relation between the two mechanisms remains the area of controversy. One group has reported that increased sorbitol pathway activity has a protective rather than detrimental role in complication-prone tissues because the pathway detoxifies toxic lipid peroxidation products. Others put forward a so-called "unifying hypothesis" suggesting that activation of several major pathways implicated in diabetic complications (eg, sorbitol pathway) occurs due to increased production of superoxide anion radicals in mitochondria and resulting poly(ADP-ribose) polymerase activation. This review (a) presents findings supporting a key role for the sorbitol pathway in oxidative stress and oxidative stress-initiated downstream mechanisms of diabetic complications, and (b) summarizes experimental evidence against a detoxifying role of the sorbitol pathway, as well as the "unifying concept."

Obrosova IG; Antioxidant Redox Sig 7 (11-12): 1543-52 (2005). Available from, as of March 27, 2010: https://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16356118

API SUPPLIERS

01

Kinsy SL

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI WW Frankfurt

Attending

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Pharm-RX Chemical

U.S.A

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HRV Global Life Sciences

India

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Roquette

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

06

Roquette

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

07

Roquette

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

08

Novel Chem

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

09

B Food Science

Japan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

10

Anhui Sinotech Industrial

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Duphat

Not Confirmed

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USDMF

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JDMF

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Listed Suppliers

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Drugs in Development

01 Pharnext

France

Duphat

Not Confirmed

02 Pharnext

France

Duphat

Not Confirmed

03 Pharnext

France

Duphat

Not Confirmed

04 Amneal Pharmaceuticals

U.S.A

Duphat

Not Confirmed

05 Pharnext

France

Duphat

Not Confirmed

06 Pharnext

France

Duphat

Not Confirmed

07 Pharnext

France

Duphat

Not Confirmed

08 Pharnext

France

Duphat

Not Confirmed

09 Charcot Marie Tooth Association

U.S.A

Duphat

Not Confirmed

10 Pharnext

France

Duphat

Not Confirmed

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FDF Dossiers

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Europe

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Listed Dossiers

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Digital Content

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NEWS #PharmaBuzz

Global Sales Information

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Finished Drug Prices

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Market Place

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APIs

Pharma Grade Sorbitol (10 MT) API needed in Belgium [ENA16967]

A CMO that focuses on OSDs, syrups, lotions, sprays and creams is looking for suppliers of Pharma Grade Sorbitol (10 MT) API for commercial purposes. The suppliers must support this enquiry with CoA.

25 Apr 2023

Sorbitol & Sodium Lauryl Sulfoacetate APIs needed in Russia [ENA09976]

One of the largest manufacturers of generics and products in the consumer healthcare segment that deals in the development and production of medicines is looking for suppliers of Sorbitol (6 kg) & Sodium Lauryl Sulfoacetate (250 kg) APIs for development purposes. The suppliers must support this enquiry with CoA.

18 Mar 2021

Various APIs needed in Qatar [ENA07552]

Qatar Pharma, a company that provides services of pharmaceutical manufacturing of intravenous solutions, large volume parenteral, eye drops and ampoules in small volume parenteral, creams, lotions, and solutions is looking for suppliers of Various APIs. Interested suppliers can contact them via their email id: purchase1@qatarpharma.org 1. Pectin 2. Silver Sulfadiazine 3. Cetyl Alcohol 4. Sodium Valproate Injectable Grade 5. Calcium Gluconate 6. Toldimfos 7. Sorbitol 8. Zinc Chloride Injectable Grade 9. Ondansetron HCI 10. Nonoxynol-9 11. Ferric Hydroxide Polymaltose Complex

12 Jun 2020

Enquiry// Mannitol, Ascorbic Acid and Sorbitol APIs needed in Iran [ENA01620]

Ersan Pharma Industrial-a rapidly growing pharmaceutical company based in Iran is looking for the suppliers of Mannitol, Ascorbic Acid and Sorbitol APIs. Interested suppliers must contact Raymon via E-mail: Pz.Raymon@ersan-pharma.com or Tel: 0098 (0)21 44693709.

25 Aug 2018

Enquiry// Sorbitol powder (18,000 kg) needed in Brazil [ENA01198]

CAS Importação e Exportação Ltda, a company working in import and distribution of raw materials for the Pharmaceutical, Veterinary, Food and Cosmetic industries is looking for suppliers of Sorbitol powder for supply to their client. Interested suppliers should contact Fernanda Bandeira via Email: import@casimp.com.br or Tel.: +55 (11) 5677-9696.

24 Jul 2018

Various Products needed in Colombia [ENA00420]

A Colombian based manufacturing and commercializing company of specialized pharmaceutical forms, located in the city of Barranquilla is searching for suppliers of following GMP grade products: 1. Glycerin- 151,958 kg 2. Gelatin- 131,608 kg 3. Vegetable oil- 85,891 kg 4. Ethyl Alcohol- 66,174 kg 5. Sorbitol Solution Sorbitan- 64,075 kg 6. Maltitol Solution (Lycasin)- 47,593 kg 7. Hydrolyzed collagen- 23,383 kg 8. Medium Chain Triglycerides- 17,301 kg 9. Ferrous fumarate- 8,848 kg 10. Acetaminophen- 4,322 kg 11. Pyridoxine Hydrochloride- 4,062 kg 12. Green Caps- 3,869 kg 13. Sorbitol Solution Sorbitan (POLYSORB)- 2,357 kg 14. Polyethylene glycol 600- 2,150 kg 15. Crospovidone- 2,018 kg 16. Geloil SC- 1,060 kg 17. Splenda Brand Sweetener (Sucralose)- 793 kg 18. Propylene glycol Monocaprylate- 783 kg 19. Itraconazole- 260 kg 20. Selenomethionine- 64 kg

19 Jul 2017

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EXCIPIENTS

Enquiry// IP grade Sorbitol 70% (600 kg) needed in India [ENA01092]

A distribution company based in India which supplies APIs, intermediates, excipients, Chemicals, Nutraceuticals, etc. is looking for suppliers of IP grade Sorbitol 70% (600 kg) for their customer.

15 Jul 2018

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REF. STANDARDS & IMPURITIES

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EDQM

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USP

ABOUT THIS PAGE

Sorbitol API Manufacturers

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

Sorbitol API Suppliers

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

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

Sorbitol API USDMF

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

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

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

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

Sorbitol API GMP

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

Sorbitol API CoA

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

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

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