Menthol BP Ph Eur USP & Tablets & Encapsulated Controlled or Slow Release, Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Menthol, 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, Bangladesh, etc.

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Menthol: CAS Number: 2216-51-5, EINECS EC Number: 218-690-9, Molecular Formula: C10H20O, Molecular Weight: 156.27, FEMA Number: 2665, HS Code ---**

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Menthol.

Menthol is an organic compound made synthetically or obtained from the oils of corn mint, peppermint, or other mints. It is a waxy, crystalline substance, clear or white in color, which is solid at room temperature and melts slightly above. Menthol has local anesthetic and counter-irritant qualities, and it is widely used to relieve minor throat irritation.

General Specifications of Menthol:
Appearance: Colorless, hexagonal crystals
Odor: Characteristic, peppermint, refreshing and sweet odor.
Solubility: Very soluble in ethanol 95%
Identification: Equal weight of camphor and menthol, mixture liquifies
Organic Volatile Impurities by GC: Negligible
Melting Point: 41-44C
Optical Rotation: -45° to -51°
Non-Volatile Residue: < 0.05%
L Menthol: 99.5%

Menthol USP Grade Specifications
C10H20O --- 156.27
Cyclohexanol, 5-methyl-2-(1-methylethyl)- [CAS 1490-04-6].

Menthol is an alcohol obtained from diverse mint oils or prepared synthetically.
Menthol may be levorotatory (l-Menthol), from natural or synthetic sources, or racemic (dl-Menthol).

Packaging and storage: Preserve in tight containers, preferably at controlled room temperature.
Labeling: Label it to indicate whether it is levorotatory or racemic.

Identification: When it is triturated with about an equal weight of camphor, of chloral hydrate, or of phenol, the mixture liquefies.
Melting range of l-Menthol: between 41 and 44C.
Congealing range of dl-Menthol: [NOTE—Perform this test preferably in a room having a temperature below 30C and a relative humidity below 50%.] Place about 10 g of racemic Menthol, previously dried in a desiccator over silica gel for 24 hours, in a dry test tube of from 18- to 20-mm internal diameter, and melt the contents at a temperature of about 40C. Suspend the test tube in water having a temperature of 23 to 25C, and stir the contents of the tube continually with a thermometer, keeping the bulb of the thermometer immersed in the liquid. Racemic Menthol congeals at a temperature between 27 and 28C. Shortly after the temperature has stabilized at the congealing point, add a few mg of dried racemic Menthol to the congealed mass, and continue the stirring: after a few minutes the temperature of the mass quickly rises to 30.5 to 32.0C.
Specific rotation: between 45 and 51 for l-Menthol; between 2 and +2 for dl-Menthol.
Limit of nonvolatile residue: Volatilize 2 g, accurately weighed, in a tared open porcelain dish on a steam bath, and dry the residue at 105 for 1 hour: the residue weighs not more than 1 mg (0.05%).
Chromatographic purity: To pass the test.
Readily oxidizable substances in dl-Menthol: Place 500 mg of dl-Menthol in a clean, dry test tube, add 10 mL of a solution of potassium permanganate, prepared by diluting 3 mL of 0.1 N potassium permanganate with water to 100 mL, and place the test tube in a beaker of water at a temperature between 45 and 50C. Remove the tube from the bath at intervals of 30 seconds, and mix quickly by shaking: the purple color of potassium permanganate is still apparent after 5 minutes.
Organic volatile impurities: meets the requirements.

Levomenthol BP Ph Eur Grade Specifications
C10H20O --- 156.3 --- CAS 2216-51-5
Action and use: Decongestant.

CHARACTERS
Appearance: Prismatic or acicular, colourless, shiny crystals.
Solubility: Practically insoluble in water, very soluble in ethanol (96 per cent) and in light petroleum, freely soluble in fatty oils and in liquid paraffin, very slightly soluble in glycerol.
mp: About 43C.

IDENTIFICATION
First identification: A, C
Second identification: B, D
A. Specific optical rotation.
B. Thin-layer chromatography.
C. Examine the chromatograms obtained in the test for related substances.
D. Dissolve 0.20 g in 0.5 mL of anhydrous pyridine. Add 3 mL of a 150 g/L solution of dinitrobenzoyl chloride in anhydrous pyridine. Heat on a water-bath for 10 min. Add 7.0 mL of water in small quantities with stirring and allow to stand in iced water for 30 min. A precipitate is formed. Allow to stand and decant the supernatant. Wash the precipitate with 2 quantities, each of 5 mL, of iced water, recrystallise from 10 mL of acetone, wash with iced acetone and dry at 75C at a pressure not exceeding 2.7 kPa for 30 min. The crystals melt at 154C to 157C.

TESTS
Solution S: Dissolve 2.50 g in 10 mL of ethanol (96 per cent) and dilute to 25.0 mL with the same solvent.
Appearance of solution: Solution S is clear and colourless.
Acidity or alkalinity: Dissolve 1.0 g in ethanol (96 per cent and dilute to 10 mL with the same solvent. Add 0.1 mL of phenolphthalein solution. The solution is colourless. Not more than 0.5 mL of 0.01 M sodium hydroxide is required to change the colour of the indicator to pink.
Specific optical rotation: -48 to -51, determined on solution S.
Related substances: To pass the test by gas chromatography.
Residue on evaporation: Maximum 0.05 per cent.

Racementhol BP Ph Eur Grade Specifications
C10H20O --- 156.3 --- CAS 89-78-1

DEFINITION
Mixture of equal parts of (1RS,2SR,5RS)-5-methyl-2-(1-methylethyl)cyclohexanol.

CHARACTERS
Appearance: Free-flowing or agglomerated, crystalline powder or prismatic or acicular, colourless, shiny crystals.
Solubility: Practically insoluble in water, very soluble in ethanol (96 per cent) and in light petroleum, freely soluble in fatty oils and in liquid paraffin, very slightly soluble in glycerol.
mp: about 34C.

IDENTIFICATION
First identification: A, C
Second identification: B, D
A. Optical rotation.
B. Thin-layer chromatography.
C. Examine the chromatograms obtained in the test for related substances.
D. Dissolve 0.20 g in 0.5 mL of anhydrous pyridine. Add 3 mL of a 150 g/L solution of dinitrobenzoyl chloride in anhydrous pyridine. Heat on a water-bath for 10 min. Add 7.0 mL of water in small quantities with stirring and allow to stand in iced water for 30 min. A precipitate is formed. Allow to stand and decant the supernatant. Wash the precipitate with 2 quantities, each of 5 mL, of iced water, recrystallise from 10 mL of acetone, wash with iced acetone and dry at 75C at a pressure not exceeding 2.7 kPa for 30 min. The crystals melt at 130C to 131C.

TESTS
Solution S: Dissolve 2.50 g in 10 mL of ethanol (96 per cent) and dilute to 25.0 mL with the same solvent.
Appearance of solution: Solution S is clear and colourless.
Acidity or alkalinity: Dissolve 1.0 g in ethanol (96 per cent) and dilute to 10 mL with the same solvent. Add 0.1 ;mL of phenolphthalein solution. The solution is colourless. Not more than 0.5 mL of 0.01 M sodium hydroxide is required to change the colour of the indicator to pink.
Optical rotation: -0.2° to + 0.2°, determined on solution S.
Related substances: To pass the test by Gas chromatography.
Residue on evaporation: Maximum 0.05 per cent.

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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Menthol SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 28-Oct-20

Product Name & Other Names: Menthol.
Synonyms : 1S,2R,5S)-5-methyl-2-(1-methylethyl)-cyclohexanol; D-Menthol; (1S,2R,5S)-(+)-Menthol.
CAS Number: 2216-51-5
EINECS EC Number: 218-690-9
Formula : C10H20O
Molecular Weight: 156.27
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):

Precautionary statements:
P264: Wash … thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P362: Take off contaminated clothing and wash before reuse.
P302+352: IF ON SKIN: Wash with soap and water.
P332+313: If skin irritation occurs: Get medical advice/attention.

Move the exposed person to fresh air at once. Get medical attention if any discomfort continues.
Ingestion: NEVER MAKE AN UNCONSCIOUS PERSON VOMIT OR DRINK FLUIDS! Immediately rinse mouth and provide fresh air. Get medical attention if any discomfort continues.
Skin Contact: Remove affected person from source of contamination. Remove contaminated clothing and affected body parts with soap and water. Get medical attention if any discomfort continues.
Eye Contact: Promptly wash eyes with plenty of water while lifting the eye lids. Continue to rinse for at least 15 minutes and get medical attention.
Inhalation: If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician.

Suitable extinguishing media: Water spray. Foam, carbon dioxide or dry powder.
Special hazards arising from the substance or mixture: Carbon oxides
Advice for firefighters: 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. 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: Do not inhale dust, vapors, mist, or gas. Avoid dust formation. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g. sand, earth, diatomaceous earth, vermiculite). 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. 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.

Exposure limit(s): Contains no substances with occupational exposure limit values.
Engineering Measures: Provide adequate general and local exhaust ventilation.
Respiratory Equipment: No specific recommendation made, but protection against nuisance dust must be used when the general level exceeds 10 mg/m3.
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.

Appearance: White or transparent powder, dust, crystals.
Odor: Characteristic.
Odor threshold: Not available.
pH: Not available.
Relative density: about 0.89
Boiling Point: (C) 216C
Melting Point: (C) 41-44C
Flash point: 101C - closed cup
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: Slightly soluble in water.
Viscosity: Not available.
Formula : C10H20O
Molecular Weight: 156.27

Stable under normal temperature conditions. Avoid excessive heat for prolonged periods of time.
Hazardous Polymerization: Will not occur.
Materials to Avoid: Strong oxidizing substances.
Hazardous Decomposition Products: Toxic gases/vapors/fumes of Oxides of Carbon.

LD 50 Oral Rat - 3300 mg/kg
LD50 Dermal - Rabbit - > 5.000 mg/kg
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.
Teratogenic Effects: Not available.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Toxicity to fish: LC50 Pimephales promelas (fathead minnow): 18.9 mg/l; 96 h.
Persistence and degradability: Readily biodegradable.
Mobility in soil: No information available.
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.

Contact specialist disposal companies. Dissolve or mix the material with a combustible solvent. Burn in chemical incinerator equipped with an afterburner and scrubber Observe all regulations.

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

USA:
SARA 302: No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313: This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.
California Prop 65 Components: This product does not contain any chemicals known to the State of California to cause cancer, birth, or any other reproductive defects.

European Labeling in Accordance with EC Directives:
H315 Causes skin irritation.

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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