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Lactobionic Acid BP & Pure Grade Manufacturers, SDS GHS MSDS Sheet

Lactobionic Acid: CAS Number: 96-82-2, EINECS EC Number: 202-538-3, Molecular Formula: C12H22O12, Molecular Weight: 358.30 HS Code ---**

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SDS MSDS Sheet of Lactobionic Acid Manufacturers

Lactobionic Acid
Pure BP n Pure Grade
Lactobionic Acid

Lactobionic acid (4-O-β-galactopyranosyl-D-gluconic acid) is a sugar acid. It is a disaccharide formed from gluconic acid and galactose. It can be formed by oxidation of lactose. Lactobionic acid is also used in the cosmetics industry as an antioxidant and in the pharmaceutical industry as an excipient for formulation.

Lactobionic Acid BP Grade
Ph Eur
C12H22O12 (acid form)ıı358.3ıı96-82-2
C12H20O11 (d-lactone)ıı340.3ıı5965-65-1

DEFINITION
Mixture in variable proportions of 4-O-b-D-galactopyranosyl-D-gluconic acid and 4-O-b-Dgalactopyranosyl-D-glucono-1,5-lactone.
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white powder.
Solubility: Freely soluble in water, slightly soluble in glacial acetic acid, in anhydrous ethanol and in methanol.
mp: About 125 °C with decomposition.

IDENTIFICATION
A. Infrared absorption spectrophotometry.
Comparisonılactobionic acid CRS.
If the spectra obtained show differences, dissolve the substance to be examined and the reference substance separately in water, dry at 105C and record new spectra using the residues.
B. Thin-layer chromatography.
Test solution: Dissolve 10 mg of the substance to be examined in water and dilute to 1 ml with the same solvent.
Reference solution: Dissolve 10 mg of lactobionic acid CRS in water and dilute to 1 ml with the same solvent.
Plate TLC silica gel plate.
Mobile phase concentrated ammonia, ethyl acetate, water, methanol.
Application: 5 μl.
Development: Over 3/4 of the plate.
Detection: Spray 3 times with ammonium molybdate solution and heat in an oven at 110C for 15 min.
Results: The principal spot in the chromatogram obtained with the test solution is similar in position and colour to the principal spot in the chromatogram obtained with the reference solution.

TESTS
Appearance of solution: The solution is clear and not more intensely coloured than reference.
Specific optical rotation: + 23.0 to + 29.0 (anhydrous substance).
Dissolve 1.0 g in 80 ml of water and dilute to 100.0 ml with the same solvent. Allow to stand for 24 h.
Reducing sugars: Maximum 0.2 per cent, calculated as glucose.
Dissolve 5.0 g in 25 ml of water  with the aid of gentle heat. Cool and add 20 ml of cupricitric solution and a few glass beads. Heat so that boiling begins after 4 min and maintain boiling for 3 min. Cool rapidly and add 100 ml of a 2.4 per cent V/V solution of glacial acetic acid and 20.0 ml of 0.025 M iodine. With continuous shaking, add 25 ml of a mixture of 6 volumes of hydrochloric acid and 94 volumes of water and, when the precipitate has dissolved, titrate the excess of iodine with 0.05 M sodium thiosulphate using 1 ml of starch solution, added towards the end of the titration, as indicator. Not less than 12.8 ml of 0.05 M sodium thiosulphate is required.
Heavy metals: Maximum 20 ppm.
Water: Maximum 5.0 per cent, determined on 0.50 g.
Total ash: Maximum 0.2 per cent.

ASSAY
Dissolve 0.350 g in 50 ml of carbon dioxide-free water, previously heated to 30C. Immediately titrate with 0.1 M sodium hydroxide and determine the 2 equivalence points potentiometrically.
The first equivalence point (V1) corresponds to the acid form of lactobionic acid and the second equivalence point (V2 - V1) corresponds to the d-lactone form.
1 ml of 0.1 M sodium hydroxide is equivalent to 35.83 mg of C12H22O12.
1 ml of 0.1 M sodium hydroxide is equivalent to 34.03 mg of C12H20O11.
The sum of the 2 results is expressed as a percentage content of lactobionic acid.

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
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Last 17 May, 2017

List of All the IP BP USP FCC ACS Grades of Chemicals
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Borax; Sodium Borate Boric Acid
Calcium Acetate Calcium Chloride
Calcium Gluconate Calcium Hydroxide
Calcium Lactate Calcium Oxide
Calcium Saccharate Calcium Sulfate
Chromic Chloride Citric Acid
Calcium Citrate Copper Gluconate
Copper Sulfate, Cupric Sulphate Cupric Chloride
Ferrous Fumarate Ferrous Gluconate
Fumaric Acid Ferrous Sulphate
Ferric Sulfate Ferric Ammonium Citrate
Ferric Chloride  
Gentian Violet Mannitol
Magnesium Chloride Magnesium Gluconate
Magnesium Lactate Dihydrate Magnesium Sulfate
Magnesium Trisilicate Maleic Acid
Malic Acid BP USP Manganese Gluconate
Manganese Sulfate Manganese Chloride
Methylene Blue Potassium Bromide
Potassium Chloride Potassium Gluconate
Potassium Bitartrate, Cream of Tartar Potassium Hydroxide
Potassium Iodide Potassium Iodate
Potassium Sorbate Sodium Acetate
Sodium Bicarbonate Sodium Butyrate
Sodium Caprylate Sodium Fluoride
Sodium Gluconate Sodium Hydroxide Pellets
Sodium Iodide Sodium Lactate
Sodium Perborate Sodium Propionate
Sodium Thiosulfate Sodium Sulfate
Stannous Chloride Dihydrate Zinc Carbonate
Zinc Chloride Zinc Gluconate
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Lactobionic Acid SDS GHS, MSDS Sheet, Material Safety Data Sheet

Section 1: Chemical Product and Company Identification

Product Name: Lactobionic Acid.
Synonym:
4-O-β-D-Galactopyranosyl-D-gluconic acid
CAS Number: 96-82-2
EINECS EC Code: 202-538-3
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: Lactobionic Acid.
CAS Number
: 96-82-2
EINECS EC Code: 202-538-3
Percentage: >97%

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

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 crystals powder or granules.
Odor: None.
Specific Gravity: NA.
pH (10% soln/water): 1.0-3.0.
Melting point/freezing point: 113 - 118C
Solubility: Soluble in water.
Molecular Formula: C12 H22 O12
Molecular Weight: 358.29

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 - > 5,000 mg/kg(4-O-ß-D-galactopyranosyl-D-gluconic acid)
LD50 Dermal - Rat - > 2,000 mg/kg(4-O-ß-D-galactopyranosyl-D-gluconic acid)
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.

Section 12: Ecological Information

Toxicity to fish: static test LC50 - Oncorhynchus mykiss (rainbow trout) - > 100 mg/l - 96 h(4-O-ß-D-galactopyranosyl-D-gluconic acid)
BOD5 and COD: Not available.
Products of Biodegradation: The product itself and its products of degradation are slightly toxic.
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 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:
TSCA: CAS# 96-82-2 is not listed on the TSCA Inventory.
SARA 313: Not applicable
SARA 311/312 Hazard Categories: Not applicable
OSHA: None of the chemicals in this product are considered highly hazardous by OSHA.
California Prop 65: California No Significant Risk Level: None of the chemicals in this product are listed.

Canada:
WHMIS Hazard Class: Not controlled.
Canada : None of the chemicals in this product are listed on the DSL/NDSL list.CAS# 96-82-2 is not listed on Canada's Ingredient Disclosure List.

EINECS EC Code: 202-538-3

Section 16 - Additional 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.