Lactobionic Acid USP NF EP BP & Pure Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Lactobionic Acid, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade 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.

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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

Spanish Fabricantes de ácido lactobiónico

Lactobionic Acid
Pure USP NF EP BP n Pure Grade Suppliers
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.

Specifications of Lactobionic Acid USP NF Grade:
C12H22O12 (acid form) --- 358.30 --- CAS 96-82-2.
C12H20O11 (δ-lactone) 340.28 --- CAS 5965-65-1
4-O-β-Galactopyranosyl-d-gluconic acid.    

DEFINITION
Lactobionic Acid is a mixture in variable proportions of 4-O-β-d-galactopyranosyl-d-gluconic acid and 4-O-β-d-galactopyranosyl-d-glucono-1,5-lactone. It contains 98% toT 102%, on the anhydrous basis.

IDENTIFICATION
A.
Infrared Absorption: To pass the test.
B. Thin-Layer Chromatography: To pass the test.

IMPURITIES
Water: 5.0% maximum.
Appearance of Solution: 120 mg/mL of Lactobionic Acid
Standard stock solution: The Sample solution is clear and not more intensely colored than the Reference solution.
Optical Rotation: 10 mg/mL of Lactobionic Acid. Allow to stand for 24 h. Acceptance criteria: +23.0° to +29.0° (anhydrous substance).
Reducing Sugars: To pass the test. Maximum 0.2% of reducing sugars, as glucose.
Articles of Botanical Origin: 0.2% maximum.

Lactobionic Acid BP Grade
Ph Eur
C12H22O12 (acid form) 358.3 CAS 96-82-2
C12H20O11 (d-lactone) 340.3 CAS 5965-65-1

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.

Lactobionic Acid EP is also manufactured by us.

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.

We also manufacture and supply as under:

Calcium Lactobionate

Lactobionic Acid

Sodium lactobionate

Orotic Acid.

Manufacturers:

MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
Current Date Time in India GMT+5:30

e-mail: info@mubychem.com

USA, Canada, Mexico and other American
neighbouring buyers may
e-mail: us@mubychem.com
Call toll-free 1-844-682-9243 (1-844-MUBYCHEM)

Manufacturers india
Copyright and Usual Disclaimer is Applicable.
Last 21 September, 2022

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Lactobionic Acid SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet
25-Oct-20

Section 1: Chemical Product and Company Identification

Product Name & Other Names : Lactobionic Acid or 4-O-β-D-Galactopyranosyl-D-gluconic acid.
CAS Number: 96-82-2
EINECS EC Code: 202-538-3
Molecular Formula: C12 H22 O12
Molecular Weight: 358.29
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.
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: Lactobionic Acid or 4-O-β-D-Galactopyranosyl-D-gluconic acid.
CAS Number: 96-82-2
EINECS EC Code: 202-538-3

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. However, it can burn at higher temperatures.
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.
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. Uninvolved persons should evacuate to a safe place.

Section 6: Accidental Release Measures

Personal precautions, protective equipment, and emergency procedures: Ventilate area of leak or spill. Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
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: 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: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). Vacuum or sweep-up and remove to an approved disposal container. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.

Section 7: Handling and Storage

Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. 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. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.). Prevent any contact with hot surfaces.
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. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents.

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.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
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. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
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. Dust deposits on floors and other surfaces may pick up moisture and cause the surfaces to become slippery and present safety hazards. Handle in accordance with good industrial hygiene and safety practice. Wash hands after handling.

Section 9: Physical and Chemical Properties

Appearance: Solid. Off-white crystals powder or granules.
Odor: None.
Odor threshold: Not available.
pH (10% soln/water): 1.0-3.0.
Relative density: Not available.
Melting point/freezing point: 113 - 118C
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: 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)
Carcinogenicity: No component of this product present at levels greater than or equal to 0.1% is identified as possible or confirmed human carcinogen by IARC, ACGIH, OSHA and NTP.
Mutagenic Effects: Not available.
Teratogenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

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)
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 federal, state, and local environmental control regulations.

Section 14: Transport Information

DOT USA, TDG Canada & ADR/RID Europe: Not dangerous goods
IMDG/IMO: 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
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.

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.