Maltitol & Maltitol Liquid Solution USP BP Ph Eur FCC Food Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Maltitol & Maltitol Liquid Solution USP BP Ph Eur 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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Maltitol & Maltitol Liquid Solution: CAS Number: 585-88-6, EINECS EC Number: 209-567-0, Molecular Formula: C12H24O11, Molecular Weight: 344.31, HS Code ---**

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Maltitol is a sugar alcohol—a type of carbohydrate that is neither sugar nor alcohol. Maltitol and other sugar alcohols such as erythritol are commonly used in low-carb or “sugar-free” products such as candy and nutrition bars. These sweeteners are similar to sugar in terms of taste, texture, and interaction with other ingredients. Maltitol is estimated to have around 75 percent to 90 percent of the sweetness of sugar. It has an E number of E965. In the United States, it is a generally recognized as safe (GRAS) substance. In chemical terms, maltitol is known as 4-O-α-glucopyranosyl-D-sorbitol. Maltitol is a disaccharide produced by hydrogenation of maltose obtained from starch. Maltitol syrup, a hydrogenated starch hydrolysate, is created by hydrogenating corn syrup, a mixture of carbohydrates produced from the hydrolysis of starch.

General Properties and Specifications of Maltitol:
White powder.
Melting point: 148C to 151C literature.
Solubility: Very soluble in water, slightly soluble in ethanol.

Specifications of Maltitol USP NF Grade:
C12H24O11 --- 344.31
d-Glucopyranosyl-d-glucitol --- [CAS 585-88-6].

DEFINITION
Maltitol contains NLT 92.0% and NMT 100.5% of d-maltitol (C12H24O11 ), calculated on the anhydrous basis. The amounts of total sugars, other polyhydric alcohols, and any polyol anhydrides, if detected, are not included in the requirements or in the calculated amount in General Notices and Requirements, 5.60.10 Other Impurities in USP and NF Articles.

IDENTIFICATION
A. Infrared Absorption
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

ASSAY
To pass the test by Chromatography
Acceptance criteria: 92.0%–100.5% on the anhydrous basis
Limit of Nickel:
To pass the test
Acceptance criteria: NMT 1 micro-g/g
Reducing Sugars:
Acceptance criteria: To pass the test corresponding to NMT 0.3% of reducing sugars, as glucose.
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count using the Plate Method does not exceed 103 cfu/g, and the total combined molds and yeasts count does not exceed 102 cfu/g.
Conductivity:
To pass the test
Acceptance criteria: NMT 20 µS/cm
Water Determination: NMT 1.0%
Packaging and Storage: Preserve in well-closed containers. No storage requirements are specified.

DEFINITION
Maltitol Solution is a water solution containing, on the anhydrous basis, NLT 50.0% of d-maltitol (C12H24O11 ) (w/w) and NMT 8.0% of d-sorbitol (C6H14O6 ) (w/w). The amounts of total sugars, other polyhydric alcohols, and any polyol anhydrides, if detected, are not included in the requirements nor in the calculated amount under Other Impurities.

IDENTIFICATION
A. Procedure
Sample: 1.4 g of Maltitol Solution
Analysis: Dissolve the Sample in 75 mL of water. Transfer 3 mL of this solution to a 15-cm test tube, add 3 mL of freshly prepared catechol (1 in 10), and mix. Add 6 mL of sulfuric acid, and mix. Gently heat the tube in a flame for about 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 by Chromatography
Acceptance criteria
Diethylene glycol: The peak area ratio of diethylene glycol to the internal standard in the Sample solution is NMT the peak area ratio of diethylene glycol to the internal standard in the Standard solution, corresponding to NMT 0.10% of diethylene glycol in Maltitol Solution.
Ethylene glycol: The peak area ratio of ethylene glycol to the internal standard in the Sample solution is NMT the peak area ratio of ethylene glycol to the internal standard in the Standard solution, corresponding to NMT 0.10% of ethylene glycol in Maltitol Solution.

ASSAY
To pass the test by Chromatography
Acceptance criteria: NLT 50.0% of d-maltitol (w/w) and NMT 8.0% of d-sorbitol (w/w), on the anhydrous basis

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
Reducing Sugars:
Acceptance criteria: To pass the test corresponding to NMT 0.3% of reducing sugars, on the anhydrous basis, as glucose.
Microbial Enumeration Tests and Tests for Specific Microorganisms: The total aerobic microbial count using the Plate Method is NMT 1000 cfu/mL, and the total combined molds and yeasts count is NMT 100 cfu/mL.
pH: 5.0–7.5, in a 14% (w/w) solution of Maltitol Solution in carbon dioxide-free water
Water Determination: NMT 31.5%
Packaging and Storage: Preserve in well-closed containers. No storage requirements are specified.

Specifications of Maltitol BP Ph Eur Grade:
C12H24O11 --- 344.3 --- CAS 585-88-6
Action and use: Sweetening agent.

DEFINITION
4-O-α-d-Glucopyranosyl-d-glucitol (d-maltitol).
Content: 98.0 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 anhydrous ethanol.

IDENTIFICATION
First identification: A
Second identification: B, C, D
A. Infrared absorption spectrophotometry
Comparison maltitol CRS.
B. Melting point: 148C to 151C.
C. Specific optical rotation: + 105.5 to + 108.5 (anhydrous substance).
D. Thin-layer chromatography: To pass the test by chromatography.
Results The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (a).

TESTS
Appearance of solution: The solution is clear and colourless.
Dissolve 5.0 g in water and dilute to 50 mL with the same solvent.
Conductivity: Maximum 20 microS/cm.
Dissolve 20.0 g in carbon dioxide-free water prepared from distilled water and dilute to 100.0 mL with the same solvent. Measure the conductivity of the solution, while gently stirring with a magnetic stirrer.
Reducing sugars: Maximum 0.2 per cent, expressed as glucose equivalent.
Related substances:
To pass the test by Liquid chromatography.
Limits:
-any impurity: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);
-total: not more than twice the area of the principal peak in the chromatogram obtained with reference solution (b) (2.0 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 1.0 per cent, determined on 1.00 g.
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 maltitol;
-less than 2.5 IU/g for parenteral preparations having a concentration of 100 g/L or more of maltitol.

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-glucitol (D-sorbitol),
B. O-α-d-glucopyranosyl-(1→4)-O-α-d-glucopyranosyl-(1→4)-d-glucitol (maltotriitol).

Specifications of Liquid Maltitol BP Ph Eur Grade:
Action and use: Excipient.

DEFINITION
Aqueous solution of a hydrogenated, partly hydrolysed starch, composed of a mixture of mainly 4-O-α-d-glucopyranosyl-d-glucitol (d-maltitol) with d-glucitol (d-sorbitol) and hydrogenated oligo- and polysaccharides.
Content:
-d-maltitol (C12H24O11): minimum 50.0 per cent m/m (anhydrous substance) and 95.0 per cent to 105.0 per cent of the content stated on the label;
-d-sorbitol (C6H14O6): maximum 8.0 per cent m/m (anhydrous substance);
-anhydrous substance: 68.0 per cent m/m to 85.0 per cent m/m.

CHARACTERS
Appearance: Clear, colourless, syrupy liquid.
Solubility: Miscible with water and with glycerol.

IDENTIFICATION
First identification: A
Second identification: B, C
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 to the principal peak in the chromatogram obtained with reference solution (a).
B. Thin-layer chromatography: To pass the test.
Results The principal spot in the chromatogram obtained with the test solution is similar in position and colour to the principal spot in the chromatogram obtained with reference solution (a).
C. To 3 mL of a freshly prepared 100 g/L solution of pyrocatechol, add 6 mL of sulfuric acid while cooling in iced water. To 3 mL of the cooled mixture, add 0.3 mL of solution S (see Tests). Heat gently over a naked flame for about 30 s. A pink colour develops.

TESTS
Solution S: Dilute 7.0 g to 50 mL with water.
Appearance of solution: Solution S is clear and colourless.
Conductivity: Maximum 10 microS/cm, measured on undiluted liquid maltitol 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: 15.0 per cent m/m to 32.0 per cent m/m, determined on 0.100 g. Use as solvent a mixture of equal volumes of anhydrous methanol and formamide. Carry out the titration at about 50C.

Specifications of Maltitol FCC Food Grade:
D-Maltitol; Hydrogenated Maltose; _-D-Glucopyranosyl-1,4-D-glucitol
C12H24O11 Formula weight 344.31
INS: 965 CAS: [585-88-6]

DESCRIPTION
Maltitol occurs as a white, crystalline powder containing small amounts of sorbitol and related polyhydric alcohols. It is very soluble in water and slightly soluble in ethanol.
Function: Sweetener; humectant; stabilizer.

REQUIREMENTS
Identification: To pass the test by thin-layer chromatography
Assay: Not less than 92.0% and not more than 100.5% of D-maltitol as C12H24O11, calculated on the dried basis.
Lead: Not more than 1 mg/kg.
Nickel: Not more than 1 mg/kg.
Other Hydrogenated Saccharides: Not more than 7.0%.
Reducing Sugars (as glucose): Not more than 0.3%.
Residue on Ignition: Not more than 0.1%.
Water: Not more than 1.5%.

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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Maltitol or Maltitol Liquid Solution SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 27-Oct-20

Product Name & Other Names: Maltitol or Maltitol Liquid Solution.
CAS#: 585-88-6
EINECS EC Number: 209-567-0
Chemical Formula: C12H24O11.
Molecular Weight: 344.31
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: Maltitol or Maltitol Liquid Solution.
CAS#: 585-88-6
EINECS EC Number: 209-567-0
% by Weight: Powder is almost 95% and the dilution of solution 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.

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.
Exposure Limits: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
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 powder or its solution in water.
Odor: Odorless.
Odor threshold: Not available.
pH (1% soln/water): Not available.
Relative density: Not available
Melting Point: 148C to 151C literature for dry substance.
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: Very soluble in water, practically insoluble in anhydrous ethanol.
Viscosity: Not available.
Chemical Formula: C12H24O11.
Molecular Weight: 344.31

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: Not available.
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.

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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