Specifications, Uses, SDS of Lactitol Manufacturers

	King of Chemicals Manufacturers
Specifications, Properties, Uses, SDS of Lactitol USP NF BP Ph Eur Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 585-86-4 & 81025-04-9 & 81025-03-8.
King of Chemicals has several associated companies having accreditations like cGMP, GLP - FDA Approved Good Manufacturing Practice and Good Laboratory Practice of WHO standard, ISO-9001, ISO-14001, ISO/IEC 17025, ISO ISO-45000, HACCP, FSSC 220000, FSSAI, "REACH" Registered, Kosher & Halal Certified. e-CTD and DMF support can be made available if needed. We offer USP NF BP Ph Eur EP IP JP Analytical Reagent FCC Food Grade Chemicals & Nutraceuticals.

Muby Chem Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies of Lactitol for actual users, including retail or small pack supplies for research and development work.

We supply 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 at best prices. We and/or our associated units have all the facilities to supply as per cGMP standard observing good manufacturing practice and good laboratory practice. We can assure low microbial count and also offer a test certificate for the same. We maintain warehouses across USA, India, and UAE. Our group exports to USA, Canada, Mexico, Argentina, Brazil, Chile, Korea, Malaysia, Thailand, Indonesia, Europe, and several other parts of the world. We supply in wholesale container loads to small pack of few grams. Solid products may be specified for it size and shape as desired by the buyer.

Lactitol is a laxative which softens the stools by pulling in water from the body to the large intestine. It is also used to reduce the amount of ammonia in the blood of patients with liver disease. Lactitol is a sugar alcohol used as a replacement bulk sweetener for low calorie foods with approximately 40% of the sweetness of sugar. Lactitol is used in a variety of low food energy or low-fat foods. High stability makes it popular for baking. It is used in candies, cookies, biscuits), chocolate, and ice cream. Lactitol is listed as an excipient in some prescription drugs.

Lactitol USP NF Grade Specifications
C12H24O11 --- 344.31
4-O- -D-Galactopyranosyl-D-glucitol --- [CAS 585-86-4].
Monohydrate. 362.34 [CAS 81025-04-9].
Dihydrate. 380.35 [CAS 81025-03-8].

Lactitol contains not less than 98.0 percent and not more than 101.0 percent of C12H24O11, calculated on the anhydrous basis.

Identification, Infrared Absorption.
Water: between 4.5% and 5.5% (monohydrate); between 9.5% and 10.5% (dihydrate); and not more than 0.5% for the anhydrous form.
Residue on ignition: not more than 0.5%.
Heavy metals: Dissolve 4 g of it in 25 mL of water: the limit is 5 microgm per gm.
Reducing sugars: To pass the test. (0.2%, as dextrose).
Related compounds: To pass the test. The total of the percentages of all related compounds is not more than 1.5%.

Lactitol Monohydrate BP Ph Eur Grade Specifications
Ph. Eur.
C12H24O11-H2O --- 362.3 --- CAS 81025-04-9
Action and use: Osmotic laxative.

DEFINITION
4-O-β-D-Galactopyranosyl-D-glucitol monohydrate.
Content: 96.5 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Very soluble in water, slightly soluble in ethanol (96 per cent), practically insoluble in methylene chloride

IDENTIFICATION
First identification: B
Second identification: A, C
A. Specific optical rotation (see Tests).
B. Infrared absorption spectrophotometry.
C. Thin-layer chromatography.

TESTS
Solution S: Dissolve 5.000 g in carbon dioxide-free water and dilute to 50.0 mL with the same solvent.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Acidity or alkalinity: To 10 mL of solution S add 10 mL of ;carbon dioxide-free water R. To 10 mL of this solution add 0.05 mL of phenolphthalein solution. Not more than 0.2 mL of 0.01 M sodium hydroxide is required to change the colour of the indicator to pink. To a further 10 mL of the solution add 0.05 mL of ;methyl red solution. Not more than 0.3 mL of 0.01 M hydrochloric acid is required to change the colour of the indicator to red.
Specific optical rotation: + 13.5 to + 15.5 (anhydrous substance), determined on solution S.
Related substances: To pass the test.
Reducing sugars: Maximum 0.2 per cent.
Lead: Maximum 0.5 ppm.
Nickel: Maximum 1 ppm.
Water: 4.5 per cent to 5.5 per cent, determined on 0.30 g.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Microbial contamination:
TAMC: acceptance criterion 103 CFU/g.
TYMC: acceptance criterion 102 CFU/g.
Absence of Escherichia coli.
Absence of Salmonella.
Absence of Pseudomonas aeruginosa.

Product Name & Other Names: Lactitol (Monohydrate, Dihydrate or Anhydrous) or 4-O-β-D-Galactopyranosyl-D-glucitol.
CAS Number: 81025-04-9 (Monohydrate), 81025-03-8 (Dihydrate) and 585-86-4 (Anhydrous)
EINECS EC Code: 209-566-5
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

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.

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.

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.

Flammability of the Product: Non-flammable.
Products of Combustion: Fumes and 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.

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.). Do not approach facing the wind.
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage: Contain spilled material. Do not inhale vapors, mist, or gas. Avoid dust formation. 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. 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. Do not store with incompatible materials like oxidizing agents, acids.

Exposure Guidelines: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels low.
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.

Physical state and appearance: Solid off-white to white crystals powder or granules.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting point/freezing point: 95C - 98C
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.
Molecular Formula: C12H24O11-H2O or C12H24O11-2H2O or C12H24O11
Molecular Weight: 362.3 or 380.35 or 344.31 depending on hydration.

Stability: It is stable in room temperature in closed containers under normal storage & handling.
Conditions of instability: Incompatible materials, Moisture
Incompatibility with various substances: Avoid high temperatures, sparks, open flames, and moisture. Avoid contact with strong oxidizing agents and acids.
Polymerization: Will not occur.

LD50 Oral - Rat: > 30,000 mg/kg
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Reproductive toxicity: No data found.
Teratogenicity: No data found.
Developmental Effects: No data found.

Toxicity to fish: No data found.
Mobility: Will likely be mobile in the environment due to its water solubility.
Persistence and Degradability: Unlikely to persist due to its water solubility.
Bioaccumulation/ Accumulation: No data found.

Waste Disposal: Waste must be disposed of in accordance with federal, state, and local environmental control regulations.

Land Transport DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
Sea transport IMDG/IMO: Not regulated.
Air Transport ICAO/IATA: Not regulated.

SARA 311/312 Hazard Categories: Not applicable
California Prop 65: California No Significant Risk Level: None of the chemicals in this product are listed.

Lactitol Manufacturers, Suppliers, Exporters, Wholesalers:

Plot No. 2900/46&47 + 2900/163to167, GIDC, Ankleshwar, Dist. Bharuch, India
India, USA, UAE
TEL: (Office) 91-22-23774610, 91-22-23723564

If I give you “My Word” Nobody can undo it.
If I sign an “Agreement” my Lawyer will undo it

Our products are for industrial and laboratory use only. The user must test the material before use. We are not dispensing chemists or druggist and do not offer over the counter type (OTC) products for medical use by individuals.

Specifications, Properties, Uses, SDS of Lactitol USP NF BP Ph Eur Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 585-86-4 & 81025-04-9 & 81025-03-8.

Lactitol Manufacturers, Suppliers, Exporters, Wholesalers: