Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance & Flavor 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. The products are offered as per required specifications and in correct shape and size in mm or meshs or microns as specified by the buyer.
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Lactitol BP USP NF Grade Manufacturers, SDS GHS MSDS Sheet

Lactitol: CAS Number: 81025-04-9 (Monohydrate), 81025-03-8 (Dihydrate) and 585-86-4 (Anhydrous), EINECS EC Number: 209-566-5, Molecular Formula: C12H24O11-H2O or C12H24O11-2H2O or C12H24O11, Molecular Weight: 362.3 or 380.35 or 344.31, HS Code ---**

For SDS MSDS Sheet Click
SDS MSDS Sheet of Lactitol BP USP NF Grade Manufacturers

Lactitol
Pure BP USP NF Grade
Lactitol

Lactitol is a sugar alcohol used as a replacement bulk sweetener for low calorie foods with approximately 40% of the sweetness of sugar. It is also used medically as a laxative.

Lactitol Monohydrate BP
Ph. Eur.
C12H24O11-H2O --- 362.3 --- 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.
IMPURITIES
A. 4-O-β-D-galactopyranosyl-D-glucopyranose (lactose),
B. 3-O-β-D-galactopyranosyl-D-glucitol (lactulitol),
C. D-mannitol,
D. galactitol (dulcitol),
E. D-glucitol (D-sorbitol).


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

Packaging and storage: Preserve in well-closed containers.
Labeling: Label it to indicate whether it is the monohydrate, the dihydrate, or the anhydrous form.
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%.

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.

Manufacturers:

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) 91-22-23770100, 23726950
Current Date Time in India GMT+5:30

e-mail: info@mubychem.com

USA & Canadian Customers may
e-mail: usa@mubychem.com
Call toll-free 1-844-682-9243 (1-844-MUBYCHEM)

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Last 9 March, 2018

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Lactitol SDS GHS, MSDS Sheet, Material Safety Data Sheet

Section 1: Chemical Product and Company Identification

Product Name: Lactitol (Monohydrate, Dihydrate or Anhydrous).
Synonym:
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
Recommended usage: Industrial Manufacturing.
Suppliers: As per letterhead.

Section 2: Hazards Identification

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.

Labeling Regulation as per GHS & EC 1272/2008 (CLP) & GHS

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: Lactitol (Monohydrate, Dihydrate or Anhydrous).
Synonym:
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

Section 4: First Aid Measures

Always seek medical advice after the first aid treatment.

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.

Section 5: Fire and Explosion Data

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

Section 6: Accidental Release Measures

Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to legal requirements.
Large Spill: 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 through the sanitary system. Be careful that the product is not present at a concentration level above TLV. Check TLV with local authorities.

Section 7: Handling and Storage

Precautions: Do not breathe dust. Keep away from incompatibles such as oxidizing agents, acids.
Storage: Keep container tightly closed. Keep container in a cool, well-ventilated area.

Section 8: Exposure Controls/Personal Protection

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 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. Suggested protective clothing might not be sufficient; consult a specialist BEFORE handling this product.

Section 9: Physical and Chemical Properties

Physical state and appearance: Solid off-white to white crystals powder or granules.
Odor: None.
Specific Gravity: NA.
pH (10% soln/water): NA.
Melting point/freezing point: 95C - 98C
Solubility: Soluble in water.
Molecular Formula: C12H24O11-H2O or C12H24O11-2H2O or C12H24O11
Molecular Weight: 362.3 or 380.35 or 344.31

Section 10: Stability and Reactivity Data

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.
Polymerization: Will not occur.

Section 11: Toxicological Information

LD50 Oral - Rat: > 30,000 mg/kg
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Reproductive toxicity: No data available.
Teratogenicity: No data available.
Developmental Effects: No data available.
The toxicological properties have not been fully investigated.

Section 12: Ecological Information

Toxicity to fish: No data available.
BOD5 and COD: Not available.
Products of Biodegradation: The product itself and its products of degradation are slightly toxic.
Mobility: Will likely be mobile in the environment due to its water solubility.
No further data available.

Section 13: Disposal Considerations

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

Section 14: Transport Information

DOT (USA) & ADR/RID: Not dangerous goods
IMDG: Not dangerous goods
IATA: Not dangerous goods

Section 15: Other Regulatory Information

USA Regulations:
SARA 313: Not applicable
SARA 311/312 Hazard Categories: Not applicable
California Prop 65: California No Significant Risk Level: None of the chemicals in this product are listed.

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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