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    Chemistry

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    Also known as: Ribitol, Adonitol, Xylite, 488-81-3, 87-99-0, D-xylitol
    Molecular Formula
    C5H12O5
    Molecular Weight
    152.15  g/mol
    InChI Key
    HEBKCHPVOIAQTA-NGQZWQHPSA-N
    FDA UNII
    353ZQ9TVDA
    Ribitol
    A five-carbon sugar alcohol derived from XYLOSE by reduction of the carbonyl group. It is as sweet as sucrose and used as a noncariogenic sweetener.
    1 2D Structure

    Ribitol

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S,4R)-pentane-1,2,3,4,5-pentol
    2.1.2 InChI
    InChI=1S/C5H12O5/c6-1-3(8)5(10)4(9)2-7/h3-10H,1-2H2/t3-,4+,5?
    2.1.3 InChI Key
    HEBKCHPVOIAQTA-NGQZWQHPSA-N
    2.1.4 Canonical SMILES
    C(C(C(C(CO)O)O)O)O
    2.1.5 Isomeric SMILES
    C([C@H](C([C@H](CO)O)O)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    353ZQ9TVDA
    2.3 Synonyms
    2.3.1 Depositor-Supplied Synonyms

    1. Ribitol

    2. Adonitol

    3. Xylite

    4. 488-81-3

    5. 87-99-0

    6. D-xylitol

    7. Adonite

    8. Adonit

    9. D-ribitol

    10. Xyliton

    11. Eutrit

    12. Klinit

    13. Xylite (sugar)

    14. Kannit

    15. Xylit

    16. Newtol

    17. 1,2,3,4,5-pentanepentol

    18. Pentitol

    19. Fluorette

    20. Xylisorb

    21. Kylit

    22. Meso-ribitol

    23. Xylo-pentitol

    24. L-ribitol

    25. (2r,3r,4s)-pentane-1,2,3,4,5-pentaol

    26. (2r,3s,4s)-pentane-1,2,3,4,5-pentol

    27. Xylitab 300

    28. Meso-xylitol

    29. L-xylitol

    30. D-adonitol

    31. (2s,4r)-pentane-1,2,3,4,5-pentol

    32. Nsc 25283

    33. Xylitol, D-

    34. Xylitol Cm 90

    35. Brn 1720523

    36. 16277-71-7

    37. Chebi:15963

    38. Chebi:17151

    39. Xylo-pentane-1,2,3,4,5-pentol

    40. 2,3-dihydro Acrivastine

    41. C-xylidex Cr 16055

    42. 353zq9tvda

    43. Vcq006kq1e

    44. Ins No.967

    45. (2r,3s,4s)-pentane-1,2,3,4,5-pentaol

    46. Xylooligosaccharide

    47. Ins-967

    48. Nsc-25283

    49. 87849-01-2

    50. 1,2,3,4,5-pentahydroxypentane

    51. E-967

    52. (2r,3r,4s)-pentane-1,2,3,4,5-pentol

    53. 4-01-00-02832 (beilstein Handbook Reference)

    54. Mfcd00064291

    55. Einecs 201-788-0

    56. Unii-353zq9tvda

    57. Unii-vcq006kq1e

    58. Adonito

    59. Xylitol [inn:ban:jan:nf]

    60. Nsc-16868

    61. Dl-arabinit

    62. Xylitol C

    63. Hsdb 7967

    64. Xylitab Dc

    65. Wood Sugar Alcohol

    66. Rb0

    67. Xylitol,(s)

    68. Einecs 207-685-7

    69. Ribitol (adonitol)

    70. Adonitol (7ci)

    71. Xylisorb 300

    72. Xylisorb 700

    73. Mfcd00064292

    74. Nsc 16868

    75. Xylitab 100

    76. Ribo-pentitol

    77. Brn 1720524

    78. D-ribitol (incorrect)

    79. L-ribitol (incorrect)

    80. Adonitol, >=99%

    81. Xylitol [vandf]

    82. Xylitol [inci]

    83. Xylitol, >=99%

    84. Adonitol [mi]

    85. Xylitol [fcc]

    86. Xylitol [jan]

    87. Xylitol [ii]

    88. Xylitol [mi]

    89. Xylitol [mart.]

    90. Xylitol [usp-rs]

    91. Xylitol [who-dd]

    92. Bmse000062

    93. Bmse000129

    94. Bmse000886

    95. Epitope Id:114702

    96. Epitope Id:114703

    97. Ec 201-788-0

    98. Schembl4250

    99. Xylitol, Analytical Standard

    100. Dsstox_cid_22514

    101. Dsstox_rid_80046

    102. Dsstox_gsid_42514

    103. Schembl15318

    104. Mls002695898

    105. Chembl96783

    106. Ribitol (6ci,8ci,9ci)

    107. Xylitol [ep Impurity]

    108. Xylitol [ep Monograph]

    109. Qspl 191

    110. Schembl1924966

    111. Chembl1865120

    112. Chembl3137744

    113. Dtxsid601032335

    114. Hy-n0538

    115. Tox21_201056

    116. S2612

    117. S4546

    118. Zinc18068098

    119. Akos015903403

    120. Akos015915193

    121. Zinc100014205

    122. Zinc100018612

    123. Ccg-214167

    124. Ccg-266218

    125. Cs-6043

    126. Db01904

    127. Db11195

    128. Db14704

    129. Cas-87-99-0

    130. Ncgc00165982-01

    131. Ncgc00165982-02

    132. Ncgc00258609-01

    133. Ncgc00390798-01

    134. Adonitol, Bioxtra, >=99.0% (hplc)

    135. As-55964

    136. Ds-11416

    137. E967

    138. Smr001562099

    139. Hy-100582

    140. Xylitol, Vetec(tm) Reagent Grade, >=99%

    141. A0171

    142. N1725

    143. Sw220290-1

    144. X0018

    145. Xylite 1000 Microg/ml In Acetonitrile:water

    146. A-3000

    147. Adonitol, Bioreagent, Suitable For Cell Culture

    148. C00379

    149. C00474

    150. X-7000

    151. Wurcs=2.0/1,1,0/[h212h]/1/

    152. Wurcs=2.0/1,1,0/[h222h]/1/

    153. A842433

    154. Q212093

    155. Q416534

    156. Xylitol, European Pharmacopoeia (ep) Reference Standard

    157. 5dcf4f57-e023-469a-b4f3-91e8349a6705

    158. Xylitol, United States Pharmacopeia (usp) Reference Standard

    159. 6684f574-c267-40cb-8828-12f2550e58d0

    160. Xylitol, Pharmaceutical Secondary Standard; Certified Reference Material

    2.4 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 152.15 g/mol
    Molecular Formula C5H12O5
    XLogP3-2.5
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count4
    Exact Mass152.06847348 g/mol
    Monoisotopic Mass152.06847348 g/mol
    Topological Polar Surface Area101 Ų
    Heavy Atom Count10
    Formal Charge0
    Complexity76.1
    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

    Sweetening Agents

    National Library of Medicine's Medical Subject Headings online file (MeSH, 2009)

    4.2 Drug Indication

    Indicated for use as a sugar substitute, and oral hygiene active ingredient.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    There has been evidence of xylitol in dental hygiene in reducing dental caries disease and also reversing the process of early caries. Xylitol increases salivary flow and pH, reduces the levels of _Streptococcus mutans_ in plaque and saliva and reduces the adhesion on the microorganism to the teeth surface. _Streptococcus mutans_ is the main target plaque microorganism, but xylitol may potentially have inhibitory actions against several other bacterial species. It prevents a shift of the bacterial community towards a more cariogenic microflora in oral environment. Oral ingestion of xylitol causes a smaller rise in plasma glucose and insulin concentrations than does the ingestion of glucose in healthy men and diabetics.

    5.2 MeSH Pharmacological Classification

    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.)

    5.3 Absorption, Distribution and Excretion

    Absorption

    Xylitol is absorbed in the small intestine via passive diffusion with a slow absorption rate.

    Route of Elimination

    No pharmacokinetic data available.

    Volume of Distribution

    No pharmacokinetic data available.

    Clearance

    No pharmacokinetic data available.

    Five healthy human volunteers (two males and three females) received an orange flavored drink containing 30 g xylitol with breakfast. Before dosing, urine was collected for 24 hr and collections were continued 24 hr after the dose of xylitol. During the collection period no foods rich in oxalate were permitted. No significant changes in urinary oxalate excretion could be detected.

    WHO/FAO: Expert Committee on Food Additives. Summary of Toxicological Data of Certain Food Additives Series 18: Xylitol (87-99-0) (1983). Available from, as of July 11, 2011: https://www.inchem.org/pages/jecfa.html

    Diets containing 20% of xylitol or one of the following carbohydrates: glucose, fructose, sucrose, xylose, sorbitol or mannitol were fed to groups of five Wistar rats for seven days. The rats were fasted for 12 hr and given a 5 uCi dose of U(14)C-oxalic acid mixed with 0.625 g/kg of xylitol or respective carbohydrate. Urine and feces were collected for 72 hr and counted for recovery of activity. Ten rats were gradually adapted to 20% xylitol diets. After a 12-hr fast these rats and 20 controls received 5 uCi of U(14)C-oxalic acid mixed with water only or together with 0.625 g/kg xylitol/body weight. Urine and feces were collected from five rats/group; tail vein blood from the other rats at intervals up to 24 hours. Urinary excretion of the label was virtually identical in all groups. The mean excretion of label in feces of control rats receiving oxalic acid was significantly lower (P <0.001) than in control rats receiving oxalate alone, or xylitol adapted rats receiving oxalate with xylitol (fecal recoveries were 77.8 and 83% respectively). The urinary excretion of label was also significantly higher among control rats receiving oxalate with xylitol when compared to control rats receiving oxalate alone. However, xylitol adapted rats excreted a significantly smaller proportion of oxalate in urine compared to controls receiving oxalate alone. The mean plasma levels of radioactivity in control rats receiving oxalic acid with xylitol were significantly higher (P <0.05) immediately after the start of the study when compared to controls receiving oxalic acid with water only or xylitol adapted rats. When samples of plasma, urine and feces were analyzed by use of thin layer chromatography, the major part of the radioactivity was recovered as oxalic acid.

    WHO/FAO: Expert Committee on Food Additives. Summary of Toxicological Data of Certain Food Additives Series 18: Xylitol (87-99-0) (1983). Available from, as of July 11, 2011: https://www.inchem.org/pages/jecfa.html

    Male (30) and female (20) CD-1 mice were either gradually adapted to 20% xylitol diets or fed a control diet. After a 12-hour fast the mice received a single oral dose of 2 uCi of U(14)C-oxalic acid in water or in an xylitol solution (a total dose of 0.625 g/kg bw). For five xylitol adapted male mice the oxalic acid dose was given with sorbitol (0.625 g/kg bw) and for another group of five with mannitol (0.625 g/kg bw). Urine and feces were collected at intervals for 72 hours to monitor the excretion of the label. ... Adaptation of male mice to 20% dietary xylitol increased the urinary excretion of the label fourfold (4.5 versus 20%). No major changes were seen in fecal excretion. Both sorbitol and mannitol increased the urinary excretion of the label while only sorbitol also affected fecal excretion of the label. Urinary excretion of oxalic acid was significantly higher in xylitol adapted mice when compared to controls receiving oxalic acid only. Even greater urinary recovery of label was observed in control mice receiving oxalic acid with xylitol. In female mice xylitol appeared to induce an even more pronounced increase in oxalic acid excretion.

    WHO/FAO: Expert Committee on Food Additives. Summary of Toxicological Data of Certain Food Additives Series 18: Xylitol (87-99-0) (1983). Available from, as of July 11, 2011: https://www.inchem.org/pages/jecfa.html

    Six groups of three Sprague-Dawley male weanling rats received semi-synthetic diets for 28 days; four of the groups were pyridoxine deficient. Diets contained either 50% glucose by weight or 30% glucose and 20% fructose. On day 28 the rats were injected three times at spaced intervals with either 15% glucose; 10% xylitol + 5% glucose; 15% fructose; or 10% xylitol + 5% fructose. Urine was collected on days 28 and 29 and rats were sacrificed and livers collected 30 minutes after a final injection on day 30. The final body weights for the rats show that the group with the best growth received fructose + xylitol injections and was pyridoxine adequate (mean weight 216.6 g) versus the group receiving fructose + fructose injection (15%) and were pyridoxine deficient (119.7 g). The poorest growing groups received glucose diets only and either xylitol or glucose and glucose injections, and were pyridoxine deficient (107.1 g, 103.1 g). The rats on the pyridoxine deficient diets tended to excrete more oxalate and have higher liver oxalate levels. Within the pyridoxine deficient group only, rats injected with xylitol tended to excrete more oxalate and have higher liver oxalate levels, but these differences were not significant. Fructose had no effect on oxalate excretion or liver oxalate levels in the rats injected with xylitol.

    WHO/FAO: Expert Committee on Food Additives. Summary of Toxicological Data of Certain Food Additives Series 18: Xylitol (87-99-0) (1983). Available from, as of July 11, 2011: https://www.inchem.org/pages/jecfa.html

    For more Absorption, Distribution and Excretion (Complete) data for Xylitol (10 total), please visit the HSDB record page.

    5.4 Metabolism/Metabolites

    In mammals, xylitol is mainly metabolized in the liver where it is oxidized to D-xylulose by xylitol dehydrogenase and cofactor NAD. D-xyluose is further phosphorylated and metabolized by xylulose kinase to xylulose 5-phosphate (Xu5P), an intermediate of the nonoxidative branch of the pentose phosphate pathway. Xu5P is reported to activate nuclear transport and the DNA-binding activities of carbohydrate response element binding protein (ChREBP) via activation of activation of protein phosphatase 2A (PP2A) _in vitro_. Activation of ChREBP thereby upregulates the gene transcription of lipogenic enzymes in vitro, which may stimulate lipogenesis in the liver.

    The biochemical pathways for formation of oxalate after intravenous injection of xylitol in humans were studied using enzymes derived from human liver. It was concluded that metabolic pathways based on a combination of the transketolase, fructokinase, and aldolase reactions can account for the production of glucose, lactate, tertronates (D-threonic and D-erythronic acids) and oxalate (precursors) during the metabolism of xylitol administered parenterally.

    WHO/FAO: Expert Committee on Food Additives. Summary of Toxicological Data of Certain Food Additives Series 18: Xylitol (87-99-0) (1983). Available from, as of July 11, 2011: https://www.inchem.org/pages/jecfa.html

    After xylitol ingestion increase of serum lactate concentration and lactate-pyruvate ratio was observed, but to a degree less than after glucose. /Investigators/ also found a marked increase of alpha-dihydroxybutyrate. Complete metabolism of xylitol produces 35 equivalents of ATP compared to 32 from glucose.

    WHO/FAO: Expert Committee on Food Additives. Summary of Toxicological Data of Certain Food Additives Series 12: Xylitol (87-99-0) (1977). Available from, as of July 6, 2011: https://www.inchem.org/pages/jecfa.html

    /In humans/ exogenous xylitol enters the pathway by conversion to D-xylulose by a nonspecific cytoplasmic polyol dehydrogenase. Phosphorylation then yields D-xylulose phosphate, the link between the glucuronic acid and the pentose phosphate pathways; the latter leads to the formation of glyceraldehyde-3-phosphate and fructose-6-phosphate, intermediate metabolites of the Embden-Meyerhof (glycolytic) pathway. Thus xylitol can be metabolized via glucose-6-phosphate to glycogen and pyruvate or lactate via the citric acid cycle to CO2. Xylitol is mainly metabolized in the liver (80% to glucose only 20%) but a small amount also in kidney, myocardium, erythrocytes, adrenal, brain, lungs and adipose tissue. Exogenous xylitol can be metabolized in large quantities, intravenously 0.4 gm/kg/hour or 40 g/day orally raises the plasma level to a maximum of 1.5-16 mg/100 mL. The metabolic rate for xylitol is identical in both healthy and diabetic or uraemic patients and patients who suffered from liver diseases.

    WHO/FAO: Expert Committee on Food Additives. Summary of Toxicological Data of Certain Food Additives Series 12: Xylitol (87-99-0) (1977). Available from, as of July 6, 2011: https://www.inchem.org/pages/jecfa.html

    In /human/ studies with (14)C-xylitol 90% of C-atoms taken up could be recovered in products and intermediates of the glycolytic and pentose phosphate pathway.

    WHO/FAO: Expert Committee on Food Additives. Summary of Toxicological Data of Certain Food Additives Series 12: Xylitol (87-99-0) (1977). Available from, as of July 6, 2011: https://www.inchem.org/pages/jecfa.html

    For more Metabolism/Metabolites (Complete) data for Xylitol (8 total), please visit the HSDB record page.

    5.5 Biological Half-Life

    No pharmacokinetic data available.

    /In humans/ the initial fast distribution phase /for xylitol/ had a half life of about four minutes, while the apparent half life of elimination was approximately 20 minutes.

    WHO/FAO: Expert Committee on Food Additives. Summary of Toxicological Data of Certain Food Additives Series 12: Xylitol (87-99-0) (1977). Available from, as of July 6, 2011: https://www.inchem.org/pages/jecfa.html

    (14)C-xylitol disappeared extremely rapidly and the calculated half life is 165 seconds. ...

    WHO/FAO: Expert Committee on Food Additives. Summary of Toxicological Data of Certain Food Additives Series 12: Xylitol (87-99-0) (1977). Available from, as of July 6, 2011: https://www.inchem.org/pages/jecfa.html

    The half-life of exhalation of (14)CO2 after feeding with xylitol in unadapted /rats/ is 295 minutes, whereas rats which were adapted for 14 days to xylitol had a half-life of 237 minutes...

    WHO/FAO: Expert Committee on Food Additives. Summary of Toxicological Data of Certain Food Additives Series 12: Xylitol (87-99-0) (1977). Available from, as of July 6, 2011: https://www.inchem.org/pages/jecfa.html

    ...Rats were administered (14)C-xylitol (250 mg) by intubation, the half-live of the resorption of xylitol was about 7 to 8 hr. The resorption rate is about 15-20% of that of glucose. After the animals had been fed xylitol for 14 days the half-life fell to 4.5 hr. ...

    WHO/FAO: Expert Committee on Food Additives. Summary of Toxicological Data of Certain Food Additives: Xylitol (87-99-0) (1977). Available from, as of July 6, 2011: https://www.inchem.org/pages/jecfa.html

    5.6 Mechanism of Action

    Xylitol is initially taken up by the microorganism and accumulates intracellularly. Accumulated xylitol is transported into an energy-consuming cycle, or the inducible fructose transport system. It is converted to non-metabolizable, toxic xylitol-5-phosphate via phosphoenolpyruvate: a constitutive fructose phosphotransferase system by _S. mutans_. This metabolic process of xylitol, without the gain of any energy molecules, results in the development of intracellular vacuoles and cell membrane degradation. _S. mutans_ dephosphorylates xylitol-5-phosphate and expels it from the cell, in which requires energy consumption. This ultimately leading to starving of microorganism and growth inhibition. Long-term exposure to xylitol can cause microorganisms to develop resistance to xylitol. This clinically beneficial selection process creates xylitol-resistant mutans strains that are less virulent and less cariogenic than their parent strains. Xylitol also increases the concentrations of ammonia and amino acids in plaque, thereby neutralizing plaque acids. A study suggests that xylitol may also promote remineralization of deeper layers of demineralized enamel by facilitating Ca2+ and phosphate movement and accessibility.

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    DMF Number : 8316

    Submission : 1989-12-07

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    About the Company : Aroma-Zone project was conceived with a simple aim to share our expertise and enthusiasm for essential oils, the potent essences of plant life. We are dedicated to providing transp...

    Aroma-Zone project was conceived with a simple aim to share our expertise and enthusiasm for essential oils, the potent essences of plant life. We are dedicated to providing transparent information about our products, including their origins, production methods, and benefits. Our detailed technical guides empower you to make informed choices that align with your preferences. Aroma-Zone has been committed to making 100% natural skincare accessible to as many people as possible, ensuring our presence both in physical stores and online for your convenience.
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    [{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704997800,"product":"FINE ORGANIC COMPOUNDSRIBITOL (488-81-3)","address":"PLOT NO.176\/A, PHASE-II,","city":"HYDERABAD. AP.","supplier":"BIOSYN RESEARCH CHEMICALS PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"SHANGHAI","customer":"Z-TRANS BIOCHEMISTRY TECHNOLOGY(SUZ","customerCountry":"CHINA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"280","totalValueFC":"1376.5","currency":"USD","unitRateINR":22880,"date":"12-Jan-2024","totalValueINR":"114400","totalValueInUsd":"1376.5","indian_port":"Hyderabad Air","hs_no":"29054900","bill_no":"6700511","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.176\/A, PHASE-II,, HYDERABAD. AP.","customerAddress":""}]
    12-Jan-2024
    12-Jan-2024
    KGS
    overview
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    ABOUT THIS PAGE

    Ribitol Manufacturers

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

    Ribitol Suppliers

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

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

    Ribitol USDMF

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

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

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

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

    Ribitol 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 Ribitol as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Ribitol 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 Ribitol 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 Ribitol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ribitol NDC to their finished compounded human drug products, they may choose to do so.

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

    Ribitol GMP

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

    Ribitol CoA

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

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

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