Polydextrose FCC Food USP NF Grade Manufacturers, with SDS GHS MSDS Sheet
Supplier, Manufacturer, Exporter of Polydextrose, 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 etc.
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Polydextrose CAS Number 68424-04-4, EINECS EC Number: --, Molecular Formula: (C6H12O6)x, Molecular Weight: Variable, HS Code ---**
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SDS MSDS Sheet of Polydextrose Manufacturers
Pure USP NF FCC Food Grade Suppliers
Polydextrose is a synthetic polymer of glucose. It is a food ingredient classified as soluble fiber by the US FDA as well as Health Canada, as of April 2013. It is frequently used to increase the dietary fiber content of food, to replace sugar, and to reduce calories and fat content. It is a multi-purpose food ingredient synthesized from dextrose (glucose), plus about 10 percent sorbitol and 1 percent citric acid. Its E number is E1200. Polydextrose is commonly used as a replacement for sugar, starch, and fat in commercial beverages, cakes, candies, dessert mixes, breakfast cereals, gelatins, frozen desserts, puddings, and salad dressings. Polydextrose is the ideal dietary fiber and prebiotics, providing body and texture in reduced calorie and sugar-free foods. It is clean-tasting and multi-functional ingredient, with high solubility, clarity, and process stability. Polydextrose is frequently used as an ingredient in low-carb, sugar-free, and diabetic cooking recipes. It is also used as a humectant, stabilizer, and thickening agent. Polydextrose is a form of soluble fiber and has shown healthful prebiotic benefits when tested in animals. It contains only 1 kcal per gram and, therefore, can help reduce calories. However, polydextrose is not universally well tolerated. As a pharmaceutical excipient, polydextrose is mainly used in the production of solid dosage forms. It has very low sweetness and it is not brittle and its compressibility is similar to that of Sucrose. It is offered as an off-white to light tan powder. Polydextrose is also available as a clear, light yellow to colourless liquid (70% dry substance).
Specifications of Polydextrose USP NF Grade:
Polydextrose is a randomly branched polymer prepared by melting and subsequent condensation of the ingredients, which consist of approximately 90 parts dextrose, 10 parts sorbitol, and up to 1-part citric acid or 0.1-part phosphoric acid. The 1,6-glycosidic linkage predominates in the polymer, but other linkages are present. It contains NLT 90.0% of dextrose polymer units, calculated on the anhydrous and ash-free basis. It contains small quantities of free dextrose, sorbitol, and 1,6-anhydro-d-glucose (levoglucosan), with traces of citric acid or phosphoric acid.
A. To 1 drop of a solution (1 in 10), add 4 drops of 5% phenol solution, then rapidly add 15 drops of sulfuric acid TS: a deep yellow to orange color is produced.
B. With vigorous swirling, add 1 mL of acetone to 1 mL of a solution (1 in 10): the solution remains clear.
C. With vigorous swirling, add 2 mL of acetone to the solution obtained in Identification test B: a heavy, milky turbidity develops immediately.
D. To 1 mL of a solution (1 in 50), add 4 mL of alkaline cupric citrate TS. Boil vigorously for 2–4 min. Remove from heat and allow the precipitate (if any) to settle: the supernatant is blue or blue-green.
Residue on Ignition: NMT 0.3%
Limit of Lead: To pass the test.
Procedure 1: Limit of 5-Hydroxymethylfurfural and Related Compounds: To pass the test.
Procedure 2: Limit of Monomers: To pass the test.
Molecular Weight Limit: To pass the test.
Acceptance criteria: No measurable peak above a molecular weight of 22,000 is found.
pH: 2.5–5.0, in a solution (1 in 10)
Water Determination: NMT 4.0%. Use a mixture of Hydranal solvent and Hydranal formamide dry (2:1) as a solvent. Perform the titration at 50° in a jacketed beaker.
Packaging and Storage: Preserve in tight, light-resistant containers. Store in a cool and dry place.
Polydextrose FCC Food Grade:Assay: Not less than 90.0% polymer, calculated on the anhydrous, ash-free basis.
INS: 1200 CAS 68424-04-4
Polydextrose occurs as an off white to light tan solid. It is a randomly bonded polymer prepared by the condensation of a melt that consists of approximately 90% D-glucose, 10% sorbitol, and 1% citric acid or 0.1% phosphoric acid on a weight basis. The 1,6-glycosidic linkage predominates in the polymer, but other possible bonds are present. The product contains small quantities of free glucose, sorbitol, and Danhydroglucoses (levoglucosan), with traces of citric acid or phosphoric acid. It may be partially reduced by transition metal catalytic hydrogenation in an aqueous solution. It may be neutralized with any food-grade base and decolorized and deionized for further purification. It is very soluble in water.
Function Bulking agent; humectant; texturizer.
A. Add 4 drops of 5% aqueous phenol solution to 1 drop of a 1:10 aqueous solution, then rapidly add 15 drops of sulfuric acid. A deep yellow to orange color appears.
B. While vigorously swirling (vortex mixer), add 1.0 mL of acetone to 1.0 mL of a 1:10 aqueous solution. The solution remains clear. Retain this solution for Identification Test C.
C. While vigorously swirling, add 2.0 mL of acetone to the solution from Identification Test B. A heavy, milky turbidity develops immediately.
D. Add 4 mL of alkaline cupric citrate TS to 1 mL of a 1:50 aqueous solution. Boil vigorously for 2 to 4 min. Remove from heat, and allow the precipitate (if any) to settle. The supernatant liquid is blue or blue-green.
5-Hydroxymethylfurfural and Related Compounds: Not more than 0.1%, calculated on the anhydrous, ash-free basis.
Lead: Not more than 0.5 mg/kg.
Molecular Weight Limit: Passes test.
Monomers: D-Anhydroglucoses: Not more than 4.0%, calculated on the anhydrous, ash-free basis; Glucose and Sorbitol: Not more than 6.0%, calculated on the anhydrous, ash-free basis.
Nickel: Not more than 2 mg/kg for hydrogenated Polydextrose.
pH of a 10% Solution: Untreated Polydextrose: Between 2.5 and 7.0; Neutralized or Decolorized Polydextrose: Between 5.0 and 6.0.
Residue on Ignition: Untreated Polydextrose: Not more than 0.3%; Neutralized or Decolorized Polydextrose: Not more than 2.0%.
Water Not more than 4.0%.
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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Last 27 August, 2022
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Polydextrose SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 12-Jul-22
Section 1: Chemical Product and Company Identification
Product Name & Other Names: Polydextrose.
CAS Number: 68424-04-4
EINECS EC Code: NA
Linear Formula: (C6H12O6)x
Molecular Weight: Varies
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.
Section 2: Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Hazard Class and Category Code(s), Regulation (EC) No 1272/2008 (CLP)
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.
Labeling Regulation EC 1272/2008 (CLP) & GHS
GHS Label Elements
Signal Word: None
Hazards not otherwise classified (HNOC):
May causes mild skin irritation.
May causes mild eye irritation.
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.
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.
Section 3: Composition and Information on Ingredients
Product Name & Other Names: Polydextrose.
CAS Number: 68424-04-4
EINECS EC Code: NA
Section 4: First Aid Measures
Always seek medical advice after the first aid treatment.
Skin: Rinse with water. Soap may be used. Seek Medical Aid.
Eyes: Wash eyes with plenty of water for at least 15 minutes, lifting lids occasionally. Seek Medical Aid.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
Ingestion: If swallowed, induce vomiting immediately after giving two glasses of water. Never give anything by mouth to an unconscious person.
Section 5: Fire and Explosion Data
Flammability of the Product: Non-flammable.
Products of Combustion: Oxides of Carbon.
Fire Fighting Media and Instructions: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Wear self-contained breathing apparatus for firefighting if necessary.
Extinguishing Media Not recommended: Avoid using solid water jet as it may scatter the fire.
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.
Section 6: Accidental Release Measures
Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. 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: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to legal requirements.
Large Spill: Do not inhale dust, vapors, mist, or gas. Avoid dust formation. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). 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.
Section 7: Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. 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. 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. 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 strong oxidizing agents.
Section 8: Exposure Controls/Personal Protection
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits.
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.
Section 9: Physical and Chemical Properties
Physical state and appearance: Solid white powder or crystals.
Odor: Not available.
Odor threshold: Not available.
pH: less than 7.
Relative density: Not available.
Melting point/freezing point: Melting point/range: 110 - 130C
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: (C6H12O6)x
Molecular Weight: Varies
Section 10: Stability and Reactivity Data
Stability: It is stable in room temperature in closed containers under normal storage & handling.
Incompatibility with various substances: Avoid high temperatures, sparks, open flames, and moisture. Avoid contact with strong oxidizing agents.
Polymerization: Will not occur.
Section 11: Toxicological Information
LD50 Oral - Rat - Not available.
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as possible or confirmed human carcinogen by IARC, ACGIH, OSHA and NTP.
Teratogenic Effects: Not available.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.
Section 12: Ecological Information
Toxicity to fish: No information available.
Persistence and Degradability: No information available.
Mobility: No information available.
Bioaccumulation/ Accumulation: No information available.
Results of PBT and vPvB assessment: No data available for assessment.
Section 13: Disposal Considerations
Waste Disposal: Waste must be disposed of in accordance with federal, state, and local environmental control regulations.
Section 14: Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not dangerous goods.
IMDG/IMO & IATA/ICAO: Not dangerous goods.
Section 15: Other Regulatory Information
SARA 311/312 Hazards: No SARA Hazards
California Prop 65:California No Significant Risk Level: None of the chemicals in this product are listed.
Section 16 - Additional Information
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.