Trehalose Dihydrate and Anhydrous USP NF BP Ph Eur FCC Food Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Trehalose Dihydrate and Anhydrous USP NF BP Ph Eur FCC Food Grade, 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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Trehalose Dihydrate and Anhydrous: CAS Number: 99-20-7 Anhydrous and 6138-23-4 Dihydrate, EINECS EC Number: 202-739-6, Molecular Formula: C12H22O11 Anhydrous and C12H22O11-2H2O Dihydrate, Molecular Weight: 342.296 g/mol (anhydrous) and 378.33 g/mol (dihydrate), HS Code ---**

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

Trehalose is a sugar consisting of two molecules of glucose. Trehalose has high water retention capabilities, and is used in food, cosmetics and as a drug.

General Properties and Specifications of Trehalose Dihydrate and Anhydrous:
Appearance: White to almost white powder.
Assay: 99% minimum.
pH of 5% solution in water: 4.5 to 6.5
Melting point: 203C (anhydrous) and 97C (dihydrate)
Solubility: Soluble in water and ethanol.

Specifications of Trehalose USP NF Grade:
C12H22O11 --- 342.30
C12H22O11- 2H2O --- 378.33
α-d-Glucopyranosyl α-d-glucopyranoside.
Anhydrous --- CAS 99-20-7
Dihydrate --- CAS 6138-23-4

DEFINITION
Trehalose is a stable, nonreducing disaccharide with two glucose molecules linked in an α,α-1,1 configuration. It is obtained through enzymatic conversion of food-grade starch. It contains NLT 97.0% and NMT 102.0% of trehalose (C12H22O11 ), calculated on the anhydrous basis.

IDENTIFICATION
A. Infrared Absorption
B.
Sample solution: 400 mg/mL of Trehalose
Analysis: Add 0.4 mL of a solution containing 1-naphthol in 95% alcohol (1 in 20) to 1 mL of the Sample solution. Gently add 2 mL of sulfuric acid to the solution.
Acceptance criteria: A violet color develops at the interface between the two solutions.
C.
Glycine solution: 40 mg/mL of glycine
Sample solution: 40 mg/mL of Trehalose
Analysis: Add 1 mL of diluted hydrochloric acid to 2 mL of the Sample solution. Allow to stand for 20 min at room temperature. Add 4 mL of sodium hydroxide TS and 2 mL of Glycine solution to the Sample solution. Heat the solution for 10 min in boiling water.
Acceptance criteria: A brown color does not develop.

ASSAY
To pass the test by Chromatographic system
Acceptance criteria: 97.0%–102.0% on the anhydrous basis

Residue on Ignition: NMT 0.1%, determined on 2.0 g of Trehalose
Related Substances: To pass the test by Chromatographic system
Acceptance criteria: For the Sample solution, the areas of any peaks corresponding to maltotriose and other polysaccharrides and eluting before trehalose are NMT half of the area of the peak corresponding to trehalose in the chromatogram of the Standard solution (0.5%). The areas of any peaks corresponding to glucose and eluting after trehalose are NMT half of the area of the peak corresponding to trehalose in the chromatogram of the Standard solution (0.5%).
Color and Clarity of Solution: To pass the test.
Optical Rotation, Specific Rotation:
Sample solution: 100 mg/mL
Acceptance criteria: +197° to +201° at 20C
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 100 cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
pH:
Sample solution: 100 mg/mL
Acceptance criteria: 4.5–6.5
Water Determination:
Sample: 0.1 g
Acceptance criteria
Anhydrous: NMT 1.0%
Dihydrate: 9.0%–11.0%
Bacterial Endotoxins Test: If labeled for use in preparing parenteral dosage forms, it also meets the following requirements. The level of bacterial endotoxins is such that the requirement in the relevant dosage form monograph(s) in which Trehalose is used can be met. Where the label states that Trehalose must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is such that the requirement in the relevant dosage form monograph(s) in which Trehalose is used can be met.
Chloride and Sulfate, Chloride:
Sample: 2.0 g
Acceptance criteria: No more chloride than corresponds to 0.70 mL of 0.01 M hydrochloric acid (NMT 0.0125%)
Chloride and Sulfate, Sulfate:
Sample: 2.0 g
Acceptance criteria: No more sulfate than corresponds to 0.83 mL of 0.005 M sulfuric acid (NMT 0.0200%)
Nitrogen Determination:
Sample: 5.0 g
Analysis: Proceed as directed in Method II, except increase the volume of sulfuric acid for digestion to 30 mL and the volume of the sodium hydroxide solution (2 in 5) to 45 mL.
Acceptance criteria: NMT 0.005%
Soluble Starch:
Sample solution: 10% Trehalose (w/v)
Analysis: Add several drops of iodine TS to the Sample solution.
Acceptance criteria: No blue color develops.
Packaging and Storage: Preserve in tight containers. No storage requirements specified.
Labeling: Where Trehalose is intended for use in the manufacture of injectable dosage forms, it is so labeled. Where Trehalose must be subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled.

Specifications of Trehalose Dihydrate BP Ph Eur Grade:
C12H22O11-2H2O --- 378.3 --- CAS 6138-23-4

DEFINITION
α-d-Glucopyranosyl α-d-glucopyranoside dihydrate (α,α-trehalose dihydrate). It is obtained by enzymatic modification of starch.
Content: 97.0 per cent to 102.0 per cent (anhydrous substance).

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

IDENTIFICATION
A. Infrared absorption spectrophotometry.
Comparison trehalose dihydrate CRS.
B. Dissolve 2 g in 5 mL of water. To 1 mL of this solution add 0.4 mL of a 50 g/L solution of α-naphthol in ethanol (96 per cent) and mix thoroughly. Carefully add 2 mL of sulfuric acid. A violet colour develops at the interface.
C. Dissolve 1 g in 25 mL of water. To 2 mL of this solution add 1 mL of dilute hydrochloric acid and mix. Keep the solution for 20 min at room temperature. Add 4 mL of a 40 g/L solution of sodium hydroxide and 2 mL of a 40 g/L solution of glycine and mix. Heat the solution in a water-bath for 10 min. No brown colour develops.

TESTS
Solution S: Dissolve 10.0 g in carbon dioxide-free water prepared from distilled water and dilute to 100.0 mL with the same solvent.
Appearance of solution: Solution S is clear and colourless.
pH: 4.5 to 6.5 for solution S.
Specific optical rotation: + 197 to + 201 (anhydrous substance), determined on solution S.
Related substances: To pass the test by Liquid chromatography.
Limits:
-impurities A, B: for each impurity, not more than 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.5 per cent);
-unspecified impurities: for each impurity, not more than the area of the principal peak in the chromatogram obtained with reference solution (c) (0.2 per cent);
-total: not more than the area of the principal peak in the chromatogram obtained with reference solution (b) (1.0 per cent);
-disregard limit: 0.5 times the area of the principal peak in the chromatogram obtained with reference solution (c) (0.1 per cent).
Chlorides: Maximum 125 ppm.
Sulfates: Maximum 200 ppm.
Soluble starch: Dissolve 1 g in 10 mL of water. Add 0.1 mL of iodine solution. No blue colour develops.
Water: 9.0 per cent to 11.0 per cent, determined on 0.10 g.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Microbial contamination:
If intended for use in the manufacture of parenteral preparations:
-TAMC: acceptance criterion 100 CFU/g.
If not intended for use in the manufacture of parenteral preparations:
-TAMC: acceptance criterion 1000 CFU/g;
-TYMC: acceptance criterion 100 CFU/g;
-absence of Escherichia coli;
-absence of Salmonella.
Bacterial endotoxins:
If intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins:
-less than 4 IU/g for parenteral preparations having a concentration of 100 g/L or less of trehalose dihydrate;
-less than 2.5 IU/g for parenteral preparations having a concentration of more than 100 g/L of trehalose dihydrate.

LABELLING
The label states:
-where applicable, the maximum concentration of bacterial endotoxins;
-where applicable, that the substance is suitable for use in the manufacture of parenteral preparations.

IMPURITIES
Specified impurities A, B
A. d-glucopyranose (glucose),
B. oligosaccharides, mainly glucosyltrehalose: mixture of α-D-glucopyranosyl α-D-glucopyranosyl-(1→4)-α-D-glucopyranoside (4-O-glucosyltrehalose or α-D-maltosyl α-D-glucoside) and α-D-glucopyranosyl-(1→6)-α-D-glucopyranosyl α-D-glucopyranoside (6-O-glucosyltrehalose or α-D-isomaltosyl α-D-glucoside).

Specifications of Trehalose FCC Food Grade:
C12H22O11·2H2O Formula wt 378.33
CAS: anhydrous [99-20-7]
CAS: dihydrate [6138-23-4]

DESCRIPTION
Trehalose occurs as a nonhygroscopic, white, crystalline powder. It is obtained through enzymatic conversion of food-grade starch into a stable, nonreducing disaccharide with two glucose molecules linked in an _,_-1,1 configuration. The powder is freely soluble or readily dispersible in water. Trehalose is typically used in its dihydrate form.
Function: Humectant; nutritive sweetener; stabilizer; thickener; texturizer.

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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Trehalose Dihydrate and Anhydrous SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 22-Nov-20

Product Name & Other Names: Trehalose Dihydrate and Anhydrous.
CAS Number: 99-20-7 Anhydrous and 6138-23-4 Dihydrate
EINECS EC Code: 202-739-6
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.

Product Name & Other Names: Trehalose Dihydrate and Anhydrous.
CAS Number: 99-20-7 Anhydrous and 6138-23-4 Dihydrate
EINECS EC Code: 202-739-6

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 to almost white powder or crystals or granules.
Odor: Not available.
Odor threshold: Not available.
pH: 4.5 to 6.5.
Relative density: Not available.
Melting point/freezing point: 203C (anhydrous) and 97C (dihydrate).
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 and ethanol.
Viscosity: Not available.
Molecular Formula: C12H22O11 Anhydrous and C12H22O11-2H2O Dihydrate
Molecular Weight: 342.296 g/mol (anhydrous) and 378.33 g/mol (dihydrate).

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.

LD50 Oral - Rat: No data available.
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: No information available. However unlikely to persist.
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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