D-sorbitol Liquid and Powder, Sorbitol 70% USP BP Ph Eur EP FCC Food Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of D-sorbitol Liquid and Powder, Sorbitol 70% USP BP Ph Eur EP FCC Food Grade, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc.

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Export to USA UAE Europe Africa Tanzania Kenya Egypt Turkey Jumbo Packing; Exports to USA UAE Europe Africa Tanzania Kenya Uganda Egypt Turkey Brazil Chile Argentina Dubai etc. Packing Palletized and Shrink Wrapped; 25kg or 50kg or 55 lbs HDPE laminated bags with an extra HMHDP liner Drum Packing for better transportation Drum Packing & Palletized Liquid Chemical Export Import Air Freighting Sorbitol Crystalline Powder Sorbitol Liquid 70%

D-sorbitol Liquid and Powder, Sorbitol 70%: CAS Number: 50-70-4, EINECS EC Number: 200-061-5, Molecular Formula: C6H14O6, Molecular Weight: 182.17, HS Code ---**

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for D-sorbitol Liquid and Powder, Sorbitol 70%.

Sorbitol, less commonly known as 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. It has lower calories per gram than sugar. Sorbitol often is used in modern cosmetics as a humectant and thickener. Sorbitol is also used as a humectant in cookies and low-moisture foods like peanut butter and fruit preserves. It is also used in baking.

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.

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.

LABELLING
The label states:
— where applicable, the maximum concentration of bacterial endotoxins;
— where applicable, that the substance is suitable for use in the manufacture of parenteral preparations.

IMPURITIES
A. D-mannitol,
B. D-iditol,
C. 4-O-α-D-glucopyranosyl-D-glucitol (D-maltitol).

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.

LABELLING
The label states the content of D-sorbitol and the content of 1,4-sorbitan (= nominal values).

Specifications of Sorbitol FCC Food Grade:
D-Sorbitol; D-Glucitol; D-Sorbite; 1,2,3,4,5,6-Hexanehexol
C6H14O6 Formula wt 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.

For Original Monographs of IP Indian Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.

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D-sorbitol Liquid and Powder, Sorbitol SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 19-Nov-20

Product Name & Other Names: D-sorbitol Liquid and Powder, Sorbitol.
CAS#: 50-70-4
EINECS EC Number: 200-061-5
Chemical Formula: C6H14O6.
Molecular Weight: 182.17
Relevant uses and uses advised against (if any): Industrial use only.
Supplier: As per letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.

Hazards not otherwise classified (HNOC):
May causes mild skin irritation.
May causes mild eye irritation.

Precautionary statements:
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P303+P361+P353: IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+313: If eye irritation persists get medical advice/attention.

Product Name & Other Names: D-sorbitol Liquid and Powder, Sorbitol.
CAS#: 50-70-4
EINECS EC Number: 200-061-5
% by Weight: Powder is almost 100% and the dilution is only with water.

Eye Contact: Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention if irritation occurs.
Skin Contact: Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.
Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing such as a collar, tie, belt, or waistband.

Flammability of the Product: May be combustible at high temperature.
Products of Combustion: Not available.
Fire Hazards in Presence of Various Substances: Slightly flammable to flammable in presence of heat.
Risks of explosion of the product in presence of mechanical impact: Not available.
Fire Fighting Media and Instructions: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
SMALL FIRE: Use DRY chemical powder.
LARGE FIRE: Use water spray, fog or foam. Do not use water jet.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and the suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.

Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Ensure adequate ventilation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment Cleanup procedures and Storage:
Small Spill: Contain spilled material. Use appropriate tools to put the spilled in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to local and regional authority requirements.
Large Spill: Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like oxidizing agents. Do not store above 23C.

Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume, or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

Physical state and appearance: White or almost white, crystalline powder or its solution in water.
Odor: Odorless.
Odor threshold: Not available.
pH (1% soln/water): 5,0 - 7 at 182 g/l at 25C.
Relative density: 1.49
Melting Point: 94C to 96C.
Initial boiling point and boiling range: Not available.
Flash point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Soluble in water.
Viscosity: Not available.
Chemical Formula: C6H14O6.
Molecular Weight: 182.17

Stability: It is stable.
Conditions of Instability: Excess heat, incompatible materials.
Incompatibility with various substances: Reactive with oxidizing agents.
Polymerization: Will not occur.

Toxicity to Animals:
LD50 Oral - Rat - 15900 mg/kg
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Ecotoxicity: Not available.
Products of Biodegradation: Possibly hazardous short-term degradation products are not likely. However, long term degradation products may arise.
Results of PBT and vPvB assessment: This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

Waste Disposal: Waste must be disposed of in accordance with environmental control regulations.

DOT USA, TDG Canada & ADR/RID Europe: Not dangerous goods.
IMDG/IMO: Not dangerous goods.
IATA: Not dangerous goods.

USA:
SARA 302: No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313: This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.
SARA 311/312 Hazards: No SARA Hazards

Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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