Mannitol USP BP Ph Eur Pure Analytical Reagent FCC Food Grade Manufacturers, with SDS MSDS Sheet

Supplier, Manufacturer, Exporter of Mannitol, 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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Mannitol CAS Number 69–65–8, EINECS EC Number 200-711-8, HS Code ---**; Molecular Weight 182.17, Molecular Formula: C6H14O6

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MSDS Sheet of Mannitol Manufacturers

Mannitol
Commercial USP BP Ph Eur Pure Analytical Reagent Grade Suppliers
Mannitol

Mannitol (also referred to as mannite or manna sugar) is a white, crystalline solid with the chemical formula C6H8(OH)6. It has several industrial uses. It is classified as a sugar alcohol. Mannitol increases blood glucose to a lesser extent than sucrose and is therefore used as a sweetener for people with diabetes, and in chewing gums. The pleasant taste and mouth-feel of mannitol also makes it a popular excipient for chewable tablets.

Mannitol USP Grade Specifications

C6H14O6 182.17
D-Mannitol.
D-Mannitol [CAS 69-65-8].
Mannitol contains not less than 96.0 percent and not more than 101.5 percent of C6H14O6, calculated on the dried basis. The amounts of total sugars, other polyhydric alcohols, and any hexitol anhydrides, if detected, are not included in the requirements nor the calculated amount under Other Impurities.

Identification: Infrared Absorption 197K.
Melting range: between 164 and 169.
Specific rotation: between +137 and +145.
Acidity: Dissolve 5.0 g in 50 mL of carbon dioxide-free water, add 3 drops of phenolphthalein TS, and titrate with 0.020 N sodium hydroxide to a distinct pink endpoint: not more than 0.30 mL of 0.020 N sodium hydroxide is required for neutralization.
Loss on drying: Dry it at 105 for 4 hours: it loses not more than 0.3% of its weight.
Chloride: A 2.0-g portion shows no more chloride than corresponds to 0.20 mL of 0.020 N hydrochloric acid (0.007%).
Sulfate: A 2.0-g portion shows no more sulfate than corresponds to 0.20 mL of 0.020 N sulfuric acid (0.01%).
Arsenic: 1 ppm.
Reducing sugars: To 5 mL of alkaline cupric citrate TS add 1 mL of a saturated solution of Mannitol (about 200 mg). Heat for 5 minutes in a boiling water bath: not more than a very slight precipitate is formed. The amount determined in this test is not included in the calculated amount under Other Impurities.


Mannitol BP Ph Eur Grade:
C6H14O6 --- 182.2 CAS 69-65-8 
Action and use: Diuretic.

DEFINITION
D-Mannitol.
Content: 97.0 per cent to 102.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white crystals or powder.
Solubility: Freely soluble in water, practically insoluble in ethanol (96 per cent).
It shows polymorphism.

IDENTIFICATION
First identification: C
Second identification: A, B, D
A. Specific optical rotation: + 23 to + 25 (dried substance).
Dissolve 2.00 g of the substance to be examined and 2.6 g of disodium tetraborate in about 20 mL of water at 30C; shake continuously for 15-30 min without further heating. Dilute the resulting clear solution to 25.0 mL with water.
B. Melting point.
C Infrared absorption spectrophotometry.
D. Thin-layer chromatography.

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 µS⋅cm-1.
Dissolve 20.0 g in carbon dioxide-free water prepared from distilled water by heating at 40-50C and dilute to 100.0 mL with the same solvent. After cooling, measure the conductivity of the solution while gently stirring with a magnetic stirrer.
Melting point: 165C to 170C.
Reducing sugars: Maximum 0.1 per cent (calculated as glucose equivalent).
Related substances: To pass the test by Liquid chromatography.
Nickel: Maximum 1 ppm.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 105C for 4 h.
Microbial contamination: To pass the test.
Bacterial endotoxins: To pass the test.

Mannitol FCC Food Grade

D-Mannitol; Mannite; 1,2,3,4,5,6-Hexanehexol
C6H14O6 Formula weight 182.17
INS: 421 CAS: [69-65-8]

DESCRIPTION
Mannitol occurs as a white, crystalline powder or as free flowing granules consisting of D-mannitol and a small quantity of sorbitol. It is soluble in water and in pyridine, very slightly soluble in alcohol, and practically insoluble in chloroform and ether.
Function: Nutritive sweetener; texturizing agent.

REQUIREMENTS
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 Preparation corresponds to that in the chromatogram of the Standard Preparation as obtained from the Assay.
Assay: Not less than 96.0% and not more than 101.5% of C6H14O6, calculated on the dried basis.
Lead: Not more than 1 mg/kg.
Loss on Drying: Not more than 0.3%.
Nickel: Not more than 1 mg/kg.
pH of a 10% (w/w) Solution: Between 4.0 and 7.5.
Reducing Sugars: Not more than 0.3%.
Residue on Ignition: Not more than 0.1%.


Mannitol Analytical Reagent Grade

HOCH2(CHOH)4CH2OH
Formula weight 182.17
CAS Number 69-65-8

REQUIREMENTS
Specific rotation [α]25°/D +23.3° to +24.3°
Reducing sugars Passes test

MAXIMUM ALLOWABLE
Insoluble matter 0.01%
Loss on drying at 105C 0.05%
Residue after ignition 0.01%
Titrable acid 0.0008 meq/g
Heavy metals (as Pb) 5 ppm

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.

We manufacture and supply as under:

Corn Syrup Solids and Corn Syrup

Dextrin

Dextrose

Galactose

High Fructose Corn Syrup HFCS

Lactose Monohydrate n Anhydrous and Directly Compressible Lactose

Liquid Glucose SO2 Free

Maltitol & Maltitol Liquid Solution

Maltodextrin

Maltose Monohydrate n Anhydrous

Mannitol

D-Mannose or Mannose

D-Ribose

Sorbitol

Sucrose

Trehalose

Xylitol

D-Xylose.

Sugar Spheres, Compressible Sugar Confectioner’s Sugar.

Manufacturers:

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
Current Date Time in India GMT+5:30

e-mail: info@mubychem.com

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Last 12 March, 2024

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Mannitol SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet
28-Oct-20

Section 1: Chemical Product and Company Identification

Product Name & Other Names: Mannitol or Mannite
CAS#: 69–65–8
EINECS EC Number: 200-711-8
Chemical Formula: C6H14O6.
Molecular Weight: 182.17
Relevant uses and uses advised against (if any): Industrial use only.
Supplier: As per letterhead.

Section 2: Hazards Identification

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.

Labeling according to GHS & Regulation (EC) No 1272/2008

GHS Label Elements
NONE

Signal Word: None

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.

Section 3: Composition and Information on Ingredients

Product Name & Other Names: Mannitol or Mannite
CAS#: 69–65–8
EINECS EC Number: 200-711-8

Section 4: First Aid Measures

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.

Section 5: Fire and Explosion Data

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.

Section 6: Accidental Release Measures

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.

Section 7: Handling and Storage

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 (73.4°\F).

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. 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.

Section 9: Physical and Chemical Properties

Physical state and appearance: White powdered solid.
Odor: Odorless.
Odor threshold: Not available.
pH (1% soln/water): 5-6.5.
Relative density: 1.5
Melting Point: 166C to 170C.
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 cold water, hot water.
Viscosity: Not available.
Chemical Formula: C6H14O6.
Molecular Weight: 182.17

Section 10: Stability and Reactivity Data

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

Section 11: Toxicological Information

Toxicity to Animals:
LD50 Oral - Rat - 13500 mg/kg
LD50 Oral - Mouse - 22000 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.

Section 12: Ecological Information

Ecotoxicity: Not available.
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.

Section 13: Disposal Considerations

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

Section 14: Transport Information

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

Section 15: Other Regulatory Information

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.

16. Other Information

DISCLAIMER: The information and recommendations set forth herein (hereinafter "Information") are presented in good faith and believed correct as of the date hereof. It is compiled from various sources and it is not necessarily all inclusive nor fully adequate in every circumstance. In addition, these suggestions should not be confused with nor followed in violation of applicable laws, regulations, rules or insurance requirements applicable. This MSDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. Individuals receiving the information must exercise their independent judgment in determining its appropriateness for a particular purpose.