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Mannitol USP Pure AR LR ACS Analytical Reagent FCC Food Grade Manufacturers, SDS MSDS Sheet
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 (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 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 FCC Food Grade
D-Mannitol; Mannite; 1,2,3,4,5,6-Hexanehexol
C6H14O6 Formula weight 182.17
INS: 421 CAS: [69-65-8]
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.
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 ACS AR Analytical Reagent Grade
Formula weight 182.17
CAS Number 69-65-8
Specific rotation [α]25°/D +23.3° to +24.3° Reducing sugars Passes test
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.
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Last 23 March, 2017
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Mannitol SDS MSDS Sheet, Material Safety Data Sheet
Section 1: Chemical Product and Company Identification
Product Name: Mannitol
EINECS EC Number: 200-711-8
Chemical Formula: C6H14O6.
Molecular Weight: 182.17
Relevant Uses: 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
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.
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
Composition Name: Mannitol
EINECS EC Number: 200-711-8
% by Weight: 100
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: Mannitol 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.
Section 6: Accidental Release Measures
Small Spill: 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 through the sanitary system.
Section 7: Handling and Storage
Precautions: Keep Mannitol away from heat. Keep away from sources of ignition. Empty containers pose a fire risk, evaporate the residue under a fume hood. Ground all equipment containing material. Do not breathe dust. Keep away from incompatibles such as oxidizing agents.
Storage: Keep containers tightly closed. Keep container in a cool, well-ventilated area. 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.
Personal Protection: Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.
Personal Protection in Case of a Large Spill: Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used to avoid inhalation of the product.
Exposure Limits: This product does not contain any hazardous materials with occupational exposure limits established by the region specific regulatory bodies.
Section 9: Physical and Chemical Properties
Physical state and appearance: Mannitol is powdered solid.
Chemical Formula: C6H14O6.
Molecular Weight: 182.17
pH (1% soln/water): 5-6.5.
Melting Point: 166C to 170C.
Specific Gravity: 1.5 (Water = 1)
Solubility: Soluble in cold water, hot water.
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.
Section 12: Ecological Information
Ecotoxicity: Not available.
Products of Biodegradation: Possibly hazardous short term degradation products are not likely. However, long term degradation products may arise.
Toxicity of the Products of Biodegradation: 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 (US) & ADR/RID: Not dangerous goods
IMDG: Not dangerous goods
IATA: Not dangerous goods
Section 15: Other Regulatory Information
TSCA: Listed on the TSCA Inventory.
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
EINECS EC Number: 200-711-8.
WHMIS (Canada): Not controlled under WHMIS (Canada).
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.