CAS Number 598-82-3 and 5965-65-1, Lactobionic Acid USP NF BP EP Ph Eur Grade Manufacturers Exporters

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CAS Number 598-82-3 and 5965-65-1, Lactobionic Acid Manufacturer Exporter

For Properties Specifications of Lactobionic Acid Click Properties, Specifications of Lactobionic Acid Manufacturer.

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The Properties and Specifications of Lactobionic Acid:

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

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).

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 125C with decomposition.

A. Infrared absorption spectrophotometry.
Comparison lactobionic 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.

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.

Lactobionic Acid USP NF Grade Specifications:
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.
UNII: 65R938S4DV

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.

Infrared Absorption: [Note— If the spectra obtained show differences, dissolve the test substance and USP Lactobionic Acid RS separately in water, dry at 105C, and record new spectra using the residues. ]
B. Thin-Layer Chromatography: Acceptance criteria: The principal spot from the Sample solution is similar in position and color to the principal spot from the Standard solution.

To pass the test.
Acceptance criteria: 98.0%–102.0% on the anhydrous basis

Water Determination
Acceptance criteria: 5.0% maximum.
Appearance of Solution
Sample solution: 120 mg/mL of Lactobionic Acid
Standard stock solution: Pipet 24.0 mL of ferric chloride CS and 6.0 mL of cobaltous chloride CS into a 100-mL volumetric flask. Dilute with 1% (w/v) hydrochloric acid to volume.
Reference solution: Pipet 12.5 mL of the Standard stock solution into a 100-mL volumetric flask. Dilute with 1% (w/v) hydrochloric acid to volume.
Acceptance criteria: The Sample solution is clear and not more intensely colored than the Reference solution.
Optical Rotation
Sample solution: 10 mg/mL of Lactobionic Acid. Allow to stand for 24 h.
Acceptance criteria: +23.0° to +29.0° (anhydrous substance).
Reducing Sugars
Sample solution: Dissolve 5.0 g of Lactobionic Acid in 25 mL of water with the aid of gentle heat, and cool.
Analysis: To the Sample solution add 20 mL of cupric citrate TS 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% solution of glacial acetic acid and 20.0 mL of 0.025 M iodine VS. With continuous shaking, add 25 mL of a mixture of 6 mL of hydrochloric acid and 94 mL of water. When the precipitate has dissolved, titrate the excess iodine with 0.05 M sodium thiosulfate VS using 1 mL of starch TS, added toward the end of the titration as an indicator.
Acceptance criteria: NLT 12.8 mL of 0.05 M sodium thiosulfate is required, corresponding to NMT 0.2% of reducing sugars, as glucose.
Articles of Botanical Origin: 0.2% maximum.

Lactobionic Acid EP is also supplied.

The Uses of Lactobionic Acid:
Lactobionic acid is used similarly to AHAs in providing antiaging and enhanced cell turnover effects. Lactobionic acid provides benefits to skin beyond traditional AHAs as a result of its unique chemical structure and molecular composition. It's a multitasker. Lactobionic acid can do it all, it: moisturisers the skin, is an antioxidant and of course exfoliates the skin.

The MSDS-SDS Hazard Statement of Lactobionic Acid:

Lactobionic Acid SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet

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.

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

Signal 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: 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.

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.). 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. 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. 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. 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.
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

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.

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.
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 controlled.
IMDG/IMO: Not controlled.
IATA: Not controlled.

Section 15: Other Regulatory Information

USA Regulations:
SARA 311/312 Hazard Categories: See section 2.
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.

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.

Lactobionic Acid Suppliers
Lactobionic Acid Structure

CAS Number 96-82-2, 50-21-5 and 598-82-3 Lactobionic Acid Manufacturer Exporter

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Copyright. 12-jan-23

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