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Sorbitol 70%, D-sorbitol Liquid Powder, USP BP Ph Eur EP FCC Food Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Sorbitol 70%, D-sorbitol Liquid Powder and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.
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Sorbitol 70%, D-sorbitol Liquid Powder SDS of Manufacturers
Synonyms: Sorbitol 70%, D-sorbitol Liquid Powder
CAS Number: 50-70-4, Molecular Weight: 182.17, Chemical Formula: C6H14O6, EINECS EC Number: 200-061-5, FEMA: ----,
Sorbitol or Glucitol is a sugar alcohol with a sweet taste which the human body metabolizes slowly. It has an E number E420 thickeners for use in food industry.
General Properties and Specifications of Sorbitol 70%:
Appearance: Clear colorless syrupy liquid. It has sweet taste.
Assay: 70% active in water
Appearance: white crystalline powder.
Relative density: 1.49
Melting point: 94C to 96C.
Solubility in water: 2350 gm/liter.
Specifications of Sorbitol Solution USP Grade:
DEFINITION
Sorbitol Solution is an aqueous solution containing NLT 64.0% of d-sorbitol (C6H14O6 ). The amounts of total sugars, other polyhydric alcohols, and any hexitol anhydrides, if detected, are not included in the requirements or in the calculated amount under General Notices, 5.60.10. Other Impurities in USP and NF Articles.
IDENTIFICATION
A. Procedure
Sample solution: Dissolve 1.4 g of Sorbitol Solution in 75 mL of water.
Analysis: Transfer 3 mL of the Sample solution to a 15-cm test tube. Add 3 mL of freshly prepared catechol solution (1 in 10), and mix. Add 6 mL of sulfuric acid, mix again, and gently heat the tube in a flame for 30 s.
Acceptance criteria: A deep pink or wine-red color appears.
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
C. Limit of Diethylene Glycol and Ethylene Glycol: To pass the test.
Acceptance criteria:
Diethylene glycol: The peak area of diethylene glycol in the Sample solution is NMT the peak area of diethylene glycol in the Standard solution, corresponding to NMT 0.10% of diethylene glycol in Sorbitol Solution.
Ethylene glycol: The peak area of ethylene glycol in the Sample solution is NMT the peak area of ethylene glycol in the Standard solution, corresponding to NMT 0.10% of ethylene glycol in Sorbitol Solution.
Residue on Ignition: NMT 0.1%, calculated on the anhydrous basis, determined on a 2-g portion
Limit of Nickel:
To pass the test.
Acceptance criteria: NMT 1 ppm, calculated on the anhydrous basis.
Procedure: Reducing Sugars:
Sample: Equivalent to 3.3 g of sorbitol on the anhydrous basis from Sorbitol Solution.
Analysis: To the Sample, add 3 mL of water, 20.0 mL of cupric citrate TS, and a few glass beads. Heat so that boiling begins after 4 min, and maintain boiling for 3 min. Cool rapidly, and add 40 mL of diluted acetic acid, 60 mL of water, and 20.0 mL of 0.05 N iodine VS. With continuous shaking, add 25 mL of a mixture of 6 mL of hydrochloric acid and 94 mL of water. When the precipitate has dissolved, titrate the excess of iodine with 0.05 N sodium thiosulfate using 2 mL of starch, added toward the end of the titration, as an indicator.
Acceptance criteria: NLT 12.8 mL of 0.05 N sodium thiosulfate VS is required, corresponding to NMT 0.3% of reducing sugars, on the anhydrous basis, as glucose. [Note— The amount determined in this test is not included in the calculated amount under General Notices, 5.60.10. Other Impurities in USP and NF Articles .]
pH: 5.0–7.5, in a 14% (w/w) solution of Sorbitol Solution in carbon dioxide-free water.
Water Determination: 28.5%–31.5%.
Packaging and Storage: Preserve in well-closed containers. No storage requirements specified.
Specifications of Sorbitol BP Ph Eur Grade:
C6H14O6 --- 182.2 --- CAS 50-70-4
Action and use: Used for parenteral nutrition.
DEFINITION
d-Glucitol (d-sorbitol).
Content: 97.0 per cent to 102.0 per cent (anhydrous substance).
CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Very soluble in water, practically insoluble in ethanol (96 per cent).
It shows polymorphism.
IDENTIFICATION
First identification: A
Second identification: B, C, D
A. Examine the chromatograms obtained in the assay.
Results The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (a).
B. Dissolve 0.5 g with heating in a mixture of 0.5 mL of pyridine and 5 mL of acetic anhydride. After 10 min, pour the solution into 25 mL of water and allow to stand in iced water for 2 h. The precipitate, recrystallised from a small volume of ethanol (96 per cent) and dried in vacuo, melts at 98C to 104C.
C. Thin-layer chromatography: To pass the chromatography test.
D. Specific optical rotation: + 4.0 to + 7.0 (anhydrous substance).
TESTS
Appearance of solution: The solution is clear and colourless.
Dissolve 5 g in water and dilute to 50 mL with the same solvent.
Conductivity: Maximum 20 microS/cm.
Reducing sugars: Maximum 0.2 per cent, expressed as glucose equivalent.
Related substances: To pass the chromatography test.
Limits:
- any impurity: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (2 per cent);
- total: not more than 1.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (3 per cent);
- disregard limit: the area of the principal peak in the chromatogram obtained with reference solution (c) (0.1 per cent).
Lead: Maximum 0.5 ppm.
Nickel: Maximum 1 ppm.
Water: Maximum 1.5 per cent, determined on 1.00 g. Use a mixture of 1 volume of formamide and 2 volumes of anhydrous methanol as solvent.
Microbial contamination:
If intended for use in the manufacture of parenteral preparations:
- TAMC: acceptance criterion 100 CFU/g .
If not intended for use in the manufacture of parenteral preparations:
- TAMC: acceptance criterion 1000 CFU/g
- TYMC: acceptance criterion 100 CFU/g
- absence of Escherichia coli
- absence of Salmonella.
Bacterial endotoxins:
If intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins:
- less than 4 IU/g for parenteral preparations having a concentration of less than 100 g/L of sorbitol;
- less than 2.5 IU/g for parenteral preparations having a concentration of 100 g/L or more of sorbitol.
Specifications of Liquid Sorbitol (Crystallising) BP Ph Eur:
Sorbitol Solution (70 per cent) (Crystallising)
Action and use: Excipient.
DEFINITION
Aqueous solution of a hydrogenated, partly hydrolysed starch.
Content:
- anhydrous substance: 68.0 per cent m/m to 72.0 per cent m/m,
- D-glucitol (D-sorbitol, C6H14O6): 92.0 per cent to 101.0 per cent (anhydrous substance).
CHARACTERS
Appearance: Clear, colourless, syrupy liquid, miscible with water.
IDENTIFICATION
A. Examine the chromatograms obtained in the assay.
B. To 7.0 g add 40 mL of water and 6.4 g of disodium tetraborate, allow to stand for 1 h, shaking occasionally, and dilute to 50.0 mL with water. Filter if necessary. The angle of rotation is 0 to + 1.5.
C. It is a clear, syrupy liquid at a temperature of 25C.
TESTS
Appearance of solution: The solution is clear and colourless.
Dilute 7.0 g to 50 mL with water.
Conductivity: Maximum 10 µS/cm1 measured on the undiluted liquid sorbitol (crystallising) while gently stirring with a magnetic stirrer.
Reducing sugars: Maximum 0.2 per cent calculated as glucose equivalent.
Lead: Maximum 0.5 ppm.
Nickel: Maximum 1 ppm.
Water: 28.0 per cent to 32.0 per cent m/m, determined on 0.1 g.
Specifications of Liquid Sorbitol (Non-crystallising) BP Ph Eur Grade:
Sorbitol Solution (70 per cent) (Non-crystallising)
Action and use: Excipient.
DEFINITION
Aqueous solution of a hydrogenated, partly hydrolysed starch.
Content:
- anhydrous substance: 68.0 per cent m/m to 72.0 per cent m/m,
- D-glucitol (D-sorbitol, C6H14O6): 72.0 per cent to 92.0 per cent (anhydrous substance).
CHARACTERS
Appearance: Clear, colourless, syrupy liquid, miscible with water.
IDENTIFICATION
A. Examine the chromatograms obtained in the assay.
B. To 7.0 g add 40 mL of water and 6.4 g of disodium tetraborate. Allow to stand for 1 h, shaking occasionally, and dilute to 50.0 mL with water. Filter if necessary. The angle of rotation is + 1.5° to + 3.5°.
C. It is a clear, syrupy liquid at 25C.
TESTS
Appearance of solution: The solution is clear and colourless.
Dilute 7.0 g to 50 mL with water.
Conductivity: Maximum 10 microS/cm1 measured on the undiluted liquid sorbitol (non crystallising) while gently stirring with a magnetic stirrer.
Reducing sugars: Maximum 0.2 per cent calculated as glucose equivalent.
Reducing sugars after hydrolysis: Maximum 9.3 per cent calculated as glucose equivalent.
Lead: Maximum 0.5 ppm.
Nickel: Maximum 1 ppm.
Water: 28.0 per cent to 32.0 per cent m/m, determined on 0.1 g.
Specifications of Partially Dehydrated Liquid Sorbitol BP Ph Eur Grade:
Action and use: Excipient.
DEFINITION
Partially dehydrated liquid sorbitol is obtained by acid-catalysed partial internal dehydration of liquid sorbitol. It contains not less than 68.0 per cent m/m and not more than 85.0 per cent m/m of anhydrous substances, composed of a mixture of mainly D-sorbitol and 1,4-sorbitan, with mannitol, hydrogenated oligo- and disaccharides, and sorbitans.
Content:
(nominal value):
- 1,4-sorbitan (C6H12O5): minimum 15.0 per cent (anhydrous substance);
- D-sorbitol (C6H14O6): minimum 25.0 per cent (anhydrous substance).
The contents of 1,4-sorbitan and D-sorbitol are within 95.0 per cent to 105.0 per cent of the nominal values.
CHARACTERS
Appearance: Clear, colourless, syrupy liquid.
Solubility: Miscible with water, practically insoluble in mineral oils and vegetable oils.
IDENTIFICATION
Examine the chromatograms obtained in the assay.
Results The 2 principal peaks in the chromatogram obtained with the test solution are similar in retention time and size to the peaks in the chromatogram obtained with reference solution (a).
TESTS
Solution S: Dilute the substance to be examined with carbon dioxide-free water prepared from distilled water to obtain a solution containing 50.0 per cent m/m of anhydrous substance.
Appearance of solution: Solution S is clear and colourless.
Conductivity: Maximum 20 µS/cm.
Measure the conductivity of solution S, while gently stirring with a magnetic stirrer.
Reducing sugars: Maximum 0.3 per cent, calculated as glucose (anhydrous substance).
Nickel: Maximum 1 ppm (anhydrous substance).
Water: 15.0 per cent to 32.0 per cent, determined on 0.10 g.
Microbial contamination:
TAMC: acceptance criterion 1000 CFU/g.
TYMC: acceptance criterion 100 CFU/g.
Absence of Escherichia coli.
Absence of Salmonella.
We also supply Sorbitol EP Grade.
Specifications of Sorbitol FCC Food Grade:
D-Sorbitol; D-Glucitol; D-Sorbite; 1,2,3,4,5,6-Hexanehexol
C6H14O6 Formula weight 182.17
INS: 420 CAS 50-70-4
DESCRIPTION
Sorbitol occurs as a white powder, as granules, or as crystalline masses. It is very soluble in water; slightly soluble in ethanol, in methanol, and in acetic acid; and insoluble in ether. It is hygroscopic.
Function: Humectant; texturizing agent; nutritive sweetener.
Identification:
A. Dissolve 1 g of sample in 75 mL of water. Transfer 3 mL of this solution into a 15-cm test tube, add 3 mL of a freshly prepared 1:10 catechol solution, and mix. Add 6 mL of sulfuric acid, mix again, then gently heat the tube in a flame for about 30 s. A deep pink or wine-red color appears.
B. The retention time of the major peak in the chromatogram of the Assay Solution corresponds to that in the chromatogram of the Standard Solution obtained in the Assay.
Assay: Not less than 91.0% and not more than 100.5% of D-Sorbitol (C6H14O6), calculated on the anhydrous basis.
Lead: Not more than 2 mg/kg.
Nickel: Not more than 1 mg/kg.
pH of a 10% (w/w) Solution: Between 3.5 and 7.0.
Reducing Sugars: Not more than 0.3%.
Residue on Ignition: Not more than 0.1%.
Water: Not more than 1.5%.
Keywords: Glucitol or Sorbitol 70%, D-sorbitol Liquid Powder IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 50-70-4 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
Manufacturer Supplier Exporter
ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIA
e-mail: info@anmol.org
Copyright and Usual Disclaimer is Applicable
Last updated
1-nov-24
Exporters to USA, Canada, UAE, Kuwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnam, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.
Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.
All products are Sold for Industrial and Laboratory Use only. No other use is permitted.
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Sorbitol 70%, D-sorbitol Liquid Powder
USP BP Ph Eur EP FCC Food Grade Manufacturers