Milk sugar or Lactobiose, or Lactose Monohydrate n Anhydrous Agglomerated and Directly Compressible Lactose Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Milk sugar or Lactobiose or Lactose Monohydrate n Anhydrous, 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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Milk sugar or Lactobiose, or Lactose Monohydrate & Anhydrous Agglomerated and Directly Compressible Lactose: CAS Number: 63-42-3 for anhydrous and 64044-51-5 for Monohydrate, EINECS EC Number: 200-559-2, Molecular Formula: C12H22O11 (anhydrous), Molecular Weight: 342.30 (anhydrous), HS Code ---**

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Milk sugar or Lactobiose, or Lactose Monohydrate n Anhydrous Agglomerated and Directly Compressible Lactose.

Lactose is a large sugar molecule, found in milk, that is made up of two smaller sugar molecules, glucose and galactose. Lactose is a disaccharide. It is a sugar composed of galactose and glucose subunits and has the molecular formula C12H22O11. It is a white, water-soluble solid with a mildly sweet taste. It is used in the food industry. Its mild flavor and easy handling properties have led to its use as a carrier and stabiliser of aromas and pharmaceutical products. Lactose is added to tablet and capsule drug products as an ingredient because of its physical and functional properties, i.e., compressibility and cost-effective use. Lactose is the carbohydrate normally obtained from whey. It may be anhydrous or contain one molecule of water of crystallization or be a mixture of both forms.

General Properties and Specifications of lactose or Milk sugar or Lactobiose monohydrate or anhydrous:
Appearance: White solid.
Assay: 99% on anhydrous basis.
Moisture: 0.5% maximum.
Ash: 0.1% maximum.
Flash point: 357C to 358C
Relative density: around 1.52
Solubility: Soluble in water.
Coliform count: <10/g
E. coli: Negative
Listeria: Negative
Salmonella: Negative
Coagulase-positive Staphylococci: Negative.

Specifications of Lactose Monohydrate USP NF Grade:
Lactose Monohydrate is a natural disaccharide, obtained from milk, which consists of one glucose and one galactose moiety. [NOTE—Lactose Monohydrate may be modified as to its physical characteristics. It may contain varying proportions of amorphous lactose.]

Packaging and storage: Preserve in tight containers.
Labeling: Where the labeling states the particle size distribution, it also indicates the d10, d50, and d90 values and the range for each. For modified Lactose Monohydrate, also label it to indicate the method of modification.
Clarity and color of solution: A solution of 1 g in 10 mL of boiling water is clear and nearly colorless. Determine the absorbance of this solution at a wavelength of 400 nm. The absorbance divided by the path length in centimeters is not more than 0.04.
Identification:
A: Infrared Absorption.
B: To pass the chromatographic test.
C: Dissolve 250 mg in 5 mL of water. Add 3 mL of ammonium hydroxide, and heat in a water bath at 80C for 10 minutes: a red color develops.
Specific rotation: Dissolve 10 g by heating in 80 mL of water to 50 . Allow to cool, and add 0.2 mL of 6 N ammonium hydroxide. Allow to stand for 30 minutes, and dilute with water to 100 mL: the specific rotation, calculated on the anhydrous basis, determined at 20C, is between +54.4 and +55.9.
Microbial limits: The total aerobic microbial count does not exceed 100 cfu per g, the total combined molds and yeasts count does not exceed 50 cfu per g, and it meets the requirements of the test for absence of Escherichia coli.
Acidity or alkalinity: Dissolve 6 g by heating in 25 mL of carbon dioxide-free water, cool, and add 0.3 mL of phenolphthalein: the solution is colorless, and not more than 0.4 mL of 0.1 N sodium hydroxide is required to produce a red color.
Loss on drying: Dry it at 80 for 2 hours: the monohydrate form loses not more than 0.5% of its weight, and the modified monohydrate form loses not more than 1.0% of its weight.
Water: between 4.5% and 5.5%, determined on a preparation containing lactose monohydrate in a mixture of methanol and formamide (2:1).
Residue on ignition: not more than 0.1%, determined on a specimen ignited at a temperature of 600C± 25C.
Heavy metals: Dissolve 4 g in 20 mL of warm water, add 1 mL of 0.1 N hydrochloric acid, and dilute with water to 25 mL: the limit is 5 Micro-g per g.
Protein and light-absorbing impurities: Measure the light absorption of a 1% (w/v) solution in the range of 210 to 300 nm. The absorbance divided by the path length in centimeters is not more than 0.25 in the range of 210 to 220 nm and is not more than 0.07 in the range of 270 to 300 nm.

DEFINITION
Anhydrous Lactose is O-β-d-galactopyranosyl-(1→4)-β-d-glucopyranose (β-lactose), or a mixture of O-β-d-galactopyranosyl-(1→4)-β-d-glucopyranose and O-β-d-galactopyranosyl-(1→4)-α-d-glucopyranose (α-lactose).

IDENTIFICATION
A. Infrared Absorption
B. Thin-Layer Chromatographic Identification Test: To pass the test.

Content of Alpha and Beta Anomers: To pass the test.
Residue on Ignition: NMT 0.1%
Clarity and Color of Solution: To pass the test.
Loss on Drying:
Analysis: Dry a sample at 80C for 2 h.
Acceptance criteria: NMT 0.5%
Water Determination: To pass the test.
Acceptance criteria: NMT 1.0%
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count is NMT 100 cfu/g and the total combined molds and yeasts count is NMT 50 cfu/g. It meets the requirements of the test for absence of Escherichia coli.
Protein and Light-Absorbing Impurities: To pass the test.
Acidity or Alkalinity:
Sample solution: Dissolve 6 g by heating in 25 mL of carbon dioxide-free water, cool, and add 0.3 mL of phenolphthalein.
Acceptance criteria: The solution is colorless, and NMT 0.4 mL of 0.1 N sodium hydroxide is required to produce a pink or red color.
Optical Rotation, Specific Rotation:
Sample solution: Dissolve 10 g by heating in 80 mL of water to 50°. Allow to cool, and add 0.2 mL of 6 N ammonium hydroxide. Allow to stand for 30 min, and dilute with water to 100 mL.
Acceptance criteria: +54.4° to +55.9°, calculated on the anhydrous basis, at 20C.
Packaging and Storage: Preserve in tight containers.
Labeling: Where the labeling indicates the relative quantities of alpha- and beta-lactose, determine compliance using Content of Alpha and Beta Anomers. Where the labeling states the particle size distribution, it also indicates the d 10 , d 50 , and d 90 values and the range for each.

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

IDENTIFICATION
First identification: A, D
Second identification: B, C, D
A. Infrared absorption spectrophotometry.
Comparison lactose monohydrate CRS.
B. Thin-layer chromatography.
To pass the test.
C. Dissolve 0.25 g in 5 mL of water. Add 5 mL of ammonia and heat in a water-bath at 80C for 10 min. A red colour develops.
D. Water (see Tests).

TESTS
Solution S: Dissolve 1.0 g in boiling water, allow to cool and dilute to 10.0 mL with water.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Acidity or alkalinity: Dissolve 6.0 g by heating in 25 mL of carbon dioxide-free water, cool and add 0.3 mL of phenolphthalein solution. The solution is colourless. Not more than 0.4 mL of 0.1 M sodium hydroxide is required to change the colour of the indicator to pink or red.
Specific optical rotation: + 54.4 to + 55.9 (anhydrous substance).
Water: 4.5 per cent to 5.5 per cent, determined on 0.50 g, using a mixture of 1 volume of formamide and 2 volumes of methanol as solvent.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Microbial contamination:
TAMC: acceptance criterion 102 CFU/g.
Absence of Escherichia coli.

Specifications of Lactose Anhydrous BP Ph Eur Grade:
Anhydrous Lactose
C12H22O11 --- 342.3 --- 63-42-3
Action and use: Excipient.

DEFINITION
O-β-d-Galactopyranosyl-(1→4)-β-d-glucopyranose or mixture of O-β-d-galactopyranosyl-(1→4)-α-d-glucopyranose and O-β-d-galactopyranosyl-(1→4)-β-d-glucopyranose.

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

IDENTIFICATION
First identification: A, D
Second identification: B, C, D
A. Infrared absorption spectrophotometry.
Comparison anhydrous lactose CRS.
B. Thin-layer chromatography
To pass the test.
C. Dissolve 0.25 g in 5 mL of water. Add 5 mL of ammonia and heat in a water-bath at 80C for 10 min. A red colour develops.
D. Water (see Tests).

TESTS
Solution S: Dissolve 1.0 g in boiling water, allow to cool and dilute to 10.0 mL with water.
Appearance of solution: Solution S is clear and not more intensely coloured than reference solution.
Acidity or alkalinity: Dissolve 6.0 g by heating in 25 mL of carbon dioxide-free water, cool and add 0.3 mL of phenolphthalein solution. The solution is colourless. Not more than 0.4 mL of 0.1 M sodium hydroxide is required to change the colour of the indicator to pink or red.
Specific optical rotation: + 54.4 to + 55.9 (anhydrous substance).
Water: Maximum 1.0 per cent, determined on 1.00 g, using a mixture of 1 volume of formamide and 2 volumes of methanol as solvent.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Microbial contamination:
TAMC: acceptance criterion 100 CFU/g.
Absence of Escherichia coli.

Lactose Monohydrate Analytical Reagent Grade:
C12H22O11-H2O --- Formula Wt 360.32
CAS Number 64044-51-5

MAXIMUM ALLOWABLE
Insoluble matter: 0.005%
Residue after ignition: 0.03%
Dextrose: Passes test
Sucrose: Passes test
Heavy metals (as Pb): 5 ppm
Iron (Fe): 5 ppm.

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.

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Milk sugar or Lactobiose, or Lactose Monohydrate & Anhydrous Agglomerated and Directly Compressible Lactose SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 25-Oct-20

Product Name & Other Names: Milk sugar or Lactobiose, or Lactose Monohydrate & Anhydrous Agglomerated and Directly Compressible Lactose.
CAS Number: 63-42-3 for anhydrous and 64044-51-5 for Monohydrate
EINECS EC Code: 200-559-2
Molecular Formula: C12H22O11 (anhydrous)
Molecular Weight: 342.30 (anhydrous)
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.

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.

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.
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.

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.). 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. 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. 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. Do not leave the material container open. 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 oxidizing agents.

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.
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.

Physical state and appearance: White solid with a mildly sweet taste.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Melting point/freezing point: Not available.
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: C12H22O11 (anhydrous)
Molecular Weight: 342.30 (anhydrous)

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: >10000 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.

Toxicity to fish: No data available.
BOD5 and COD: Not available.
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 information available. However unlikely to accumulate.

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

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

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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