CAS Number 69-65-8, Mannitol USP EP IP BP Ph Eur Analytical Reagent FCC Food Grade Manufacturers Exporters
CAS Number 69-65-8, Mannitol USP EP IP BP Ph Eur Analytical Reagent FCC Food Grade Manufacturer ExporterFor Properties Specifications of Mannitol Click Properties, Specifications of Mannitol Manufacturer.
For Uses of Mannitol Click Uses of Mannitol Manufacturer.
For For SDS MSDS Sheet of Mannitol Click SDS Safety Data Sheet MSDS Sheet of Mannitol Manufacturer.
The Properties and Specifications of Mannitol:
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
TESTS
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.
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 USP
C6H14O6 182.17
D-Mannitol.
D-Mannitol CAS 69-65-8Mannitol 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, 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 69-65-8DESCRIPTION
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
REQUIREMENTS
Formula weight 182.17
CAS Number 69-65-8
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
We also manufacture Mannitol IP and EP Grades.
The Uses of Mannitol:
Mannitol is 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.
The MSDS-SDS Hazard Statement of Mannitol:
Mannitol SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 24-Nov-24Section 1: Chemical Product and Company Identification
Product Name & Other Names: Mannitol or Mannite
CAS#: 69-65-8
EINECS EC Number: 200-711-8
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 1272/2008Not 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
NONESignal Word: None
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.
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: 200-711-8Section 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.
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 solid water jet as it can 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.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.).
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.
Large Spill: Use a shovel to put the material into a convenient waste disposal container.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. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
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 inhalation of dust/mist/vapor. Do not store with incompatible materials like oxidizing agents. Do not store above 23C (73.4F).Section 8: Exposure Controls/Personal Protection
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels low.
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.
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.
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. Handle in accordance with good industrial hygiene and safety practice.Section 9: Physical and Chemical Properties
Physical state and appearance: White powdered solid.
Odor: Odorless.
Odor threshold: Not applicable.
pH (1% soln/water): 5-6.5.
Relative density: 1.5
Melting Point: 166C to 170C.
Initial boiling point and boiling range: No data found.
Flash point: No data found.
Auto-ignition temperature: No data found.
Decomposition temperature: No data found.
Upper/lower flammability or explosive limits: No data found.
Vapor pressure: No data found.
Vapor density: No data found.
Evaporation rate: No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility: Soluble in water.
Viscosity: No data found.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: No data found.
Developmental Toxicity: No data found.
Reproductive Effects: No data found.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. Follow all the pollution control rules.
Section 14: Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not controlled.
IMDG/IMO: Not controlled.
IATA: Not controlled.Section 15: Other Regulatory Information
USA:
16. Other Information
SARA 311/312 Hazards: See section 2.DISCLAIMER: The information and recommendations set forth herein 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.
Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is an off-shoot of Anmol Chemicals Taloja. It is located in MIDC Taloja and it is manufacturing pharmaceutical grades of API, Excepients, Food grade and Reagent grade chemicals. Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies for actual users, retail or small pack supplies for research and development chemicals, fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, Analytical reagent grade, IP BP USP Ph Eur EP JP and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals, Mineral Fortifiers at best prices.
Mannitol StructureCAS Number 69-65-8, Mannitol Manufacturer Exporter
ANMOL CHEMICALS & PHARMACEUTICALS Pvt. Ltd.
India, USA, Europe, UAE
TELEPHONE: +912223770100
Navi Mumbai, INDIAe-mail: info(At the rate i.e. @)anmol.org
Copyright. 11-dec-24
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