Betadex or beta-Cyclodextrin or Caraway or Cycloheptaamylose or Cyclomaltoheptaose or Schardinger beta-Dextrin Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Betadex or beta-Cyclodextrin, 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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Betadex or beta-Cyclodextrin or Caraway or Cycloheptaamylose or Cyclomaltoheptaose or Schardinger beta-Dextrin: CAS Number: 7585-39-9, EINECS EC Number: 231-493-2, Molecular Formula: C42H70O35 or (C6H10O5)7, Molecular Weight: 1134.98, FEMA Number: 4028, HS Code ---**

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Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Betadex or beta-Cyclodextrin or Caraway or Cycloheptaamylose or Cyclomaltoheptaose or Schardinger beta-Dextrin.

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SDS MSDS Sheet of Betadex or beta-Cyclodextrin or Caraway or Cycloheptaamylose or Cyclomaltoheptaose or Schardinger beta-Dextrin Manufacturers

Betadex
beta-Cyclodextrin or Caraway or Cycloheptaamylose or Cyclomaltoheptaose or Schardinger beta-Dextrin Pure Suppliers
Betadex

Betadex or beta-cyclodextrin or Cyclomaltoheptaose, is a chemical reagent and complexing agent often used in pharmaceutical industry. Betadex or Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven α-1,4-linked D-glucopyranosyl units. It is used in personal care products like toothpastes, skin creams and dusting powders. It finds applications in the cosmetic industry for products like detergents and perfumes for the controlled release of fragrances. It is also used to produce HPLC columns allowing chiral enantiomers separation and used  to decrease the level of cholesterol in milk fat.

General Properties and Specifications of Betadex or β-Cyclodextrin or Caraway or Cycloheptaamylose or Cyclomaltoheptaose or Schardinger β-Dextrin:
Appearance: White to slight orange or green powder or crystal.
Assay: 99% minimum.
Water: 14% maximum.
Melting point: 290C to 300C literature.
Soluble: Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol. It is used in food as flavoring agent or adjuvant, and as formulation aid.
Appearance of solution in hot water: Almost transparent.


Specifications of Betadex USP NF Grade:
(C6H10O5 )7 1134.98
Beta Cyclodextrin --- 7585-39-9.

DEFINITION
Betadex is a nonreducing cyclic compound composed of seven alpha-(1–4) linked d-glucopyranosyl units. It contains NLT 98.0% and NMT 102.0% of betadex (C6H10O5)7, calculated on the anhydrous basis.

IDENTIFICATION
A.
Infrared Absorption: On undried specimen
B. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
C. It meets the requirements of the test for Optical Rotation.
D.
Sample: 0.2 g
Analysis: Mix the Sample with 2 mL of iodine, warm in a water bath to dissolve, and allow to stand at room temperature.
Acceptance criteria: A yellow-brown precipitate is formed.

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

Residue on Ignition: NMT 0.1%
Limit of Reducing Sugars:
To pass the test.
Acceptance criteria: 0.2%; the absorbance of the Sample solution is NMT that of the Standard solution.
Limit of Light-Absorbing Impurities:
To pass the test.
Acceptance criteria:
Absorbance:
NMT 0.10, 230–350 nm
NMT 0.05, 350–750 nm
Related Compounds:
To pass the test.
Acceptance criteria:
Alpha cyclodextrin: 0.25%; the area of any peak corresponding to alpha cyclodextrin is NMT 0.5 times the area of the corresponding peak from the Standard solution.
Gamma cyclodextrin: 0.25%; the area of any peak corresponding to gamma cyclodextrin is NMT 0.5 times the area of the corresponding peak from the Standard solution.
Other related substances: 0.5%; the sum of all of the peak areas, excluding the alpha cyclodextrin, beta cyclodextrin, gamma cyclodextrin, and artifact peaks is NMT the area of the peak due to betadex (beta cyclodextrin) from the Standard solution.
Microbial Enumeration Tests and Tests for Specified Microorganisms: The total aerobic microbial count does not exceed 103 cfu/g, and the total combined molds and yeasts count does not exceed 102 cfu/g. It meets the requirements of the tests for absence of Salmonella species and Escherichia coli.
Optical Rotation, Specific Rotation:
Sample solution: 10 mg/mL in water
Acceptance criteria: 160° to +164°, determined at 20C
Water Determination: NMT 14.0%
Color and Clarity of Solution:
Sample solution: Dissolve 0.2 g in 20.0 mL of freshly boiled and cooled water.
Acceptance criteria: The resulting solution is clear and colorless.
pH:
Sample solution: Add 0.1 mL of a saturated solution of potassium chloride to 10 mL of a 10 mg/mL aqueous solution of Betadex.
Acceptance criteria:  5.0–8.0
Packaging and Storage: Preserve in tight containers. No storage requirements specified.


Specifications of Betadex BP Ph Eur Grade:
Betacyclodextrin
[C6H10O5]7 --- 1135 --- 7585-39-9
Action and use: Carrier molecule for drug delivery systems.

DEFINITION
Cycloheptakis-(1→4)-(α-d-glucopyranosyl) (cyclomaltoheptaose or β-cyclodextrin).
Content: 98.0 per cent to 101.0 per cent (dried substance).

CHARACTERS
Appearance: White or almost white, amorphous or crystalline powder.
Solubility: Sparingly soluble in water and in propylene glycol, practically insoluble in anhydrous ethanol and in methylene chloride.

IDENTIFICATION
A. Specific optical rotation (see Tests).
B. Examine the chromatograms obtained in the assay.
Results: The principal peak in the chromatogram obtained with test solution (b) is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution (c).
C. Dissolve 0.2 g in 2 mL of iodine solution by warming on a water-bath, and allow to stand at room temperature. A yellowish-brown precipitate is formed.

TESTS
Solution S: Dissolve 1.000 g in carbon dioxide-free water with heating, allow to cool and dilute to 100.0 mL with the same solvent.
Appearance of solution: Solution S is clear.
pH: 5.0 to 8.0.
To 10 mL of solution S add 0.1 mL of a saturated solution of potassium chloride.
Specific optical rotation: + 160 to + 164 (dried substance), determined on solution S.
Reducing sugars: Maximum 0.2 per cent.
Light-absorbing impurities: Examine solution S between 230 nm and 750 nm. Between 230 nm and 350 nm, the absorbance is not greater than 0.10. Between 350 nm and 750 nm, the absorbance is not greater than 0.05.
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 corresponding peak in the chromatogram obtained with reference solution (b) (0.25 per cent);
-sum of impurities other than A and B: not more than 0.5 times the area of the peak due to betadex in the chromatogram obtained with reference solution (b) (0.5 per cent).
Residual solvents: To pass the test by gas chromatography.
Limits:
-trichloroethylene: maximum 10 ppm;
-toluene: maximum 10 ppm.
Loss on drying: Maximum 16.0 per cent, determined on 1.000 g by drying in an oven at 120 °C for 2 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.

STORAGE
In an airtight container.

IMPURITIES
Specified impurities A, B
A. cyclohexakis-(1→4)-(α-d-glucopyranosyl) (alfadex or cyclomaltohexaose or α-cyclodextrin),
B. cyclooctakis-(1→4)-(α-d-glucopyranosyl) (cyclomaltooctaose or γ-cyclodextrin).


Specifications of beta-Cyclodextrin FCC Food Grade:
β-Cyclodextrin; BCD
(C6H10O5)7 Formula wt 1135.0
INS: 459 CAS: [7585-39-9]

DESCRIPTION
Beta-Cyclodextrin occurs as a white, fine, crystalline solid, frequently a fine, crystalline powder. It is a nonreducing cyclic compound consisting of seven alpha-(1,4) linked D-glucopyranosyl units. It is slightly soluble in water.
Function: Encapsulating agent; stabilizer.

REQUIREMENTS
Identification:
A. The infrared absorption spectrum of a potassium bromide dispersion of sample exhibits relative maxima at the same wavelengths as those of a similar preparation of USP beta-Cyclodextrin Reference Standard.
B. The retention time of the major peak in the chromatogram of Assay Preparation corresponds to that in the chromatogram of Standard Preparation, obtained as directed in the Assay.
Assay: Not less than 98.0% and not more than 101.0% of (C6H10O5)7 as beta-Cyclodextrin, calculated on the anhydrous basis.
Lead: Not more than 1 mg/kg.
Optical (Specific) Rotation [α]D20°: Between +160° and +164°, calculated on the anhydrous basis.
Reducing Sugars (dextrose equivalent): Not more than 1.0%, calculated on the anhydrous basis.
Residue on Ignition: Not more than 0.1%.
Toluene: Not more than 1 mg/kg.
Trichloroethylene: Not more than 1 mg/kg.
Water: Not more than 14.0%.

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 Hydroxypropyl Betadex.

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 1-877-682-9243 (1-877-MUBYCHEM)

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Copyright and Usual Disclaimer is Applicable.
Last 2 October, 2023

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Betadex or beta-Cyclodextrin or Caraway or Cycloheptaamylose or Cyclomaltoheptaose or Schardinger beta-Dextrin SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet

Section 1: Chemical Product and Company Identification

Product Name & Other Names: Betadex or beta-Cyclodextrin or Caraway or Cycloheptaamylose or Cyclomaltoheptaose or Schardinger beta-Dextrin.
CAS Number: 7585-39-9
EINECS EC Code: 231-493-2
Molecular Formula: C42H70O35 or (C6H10O5)7
Molecular Weight: 1134.98
Relevant uses and uses advised against (if any): 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.
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.

Section 3: Composition and Information on Ingredients

Product Name & Other Names: Betadex or beta-Cyclodextrin or Caraway or Cycloheptaamylose or Cyclomaltoheptaose or Schardinger beta-Dextrin.
CAS Number: 7585-39-9
EINECS EC Code: 231-493-2

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.
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.

Section 6: Accidental Release Measures

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.

Section 7: Handling and Storage

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.

Section 8: Exposure Controls/Personal Protection

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.

Section 9: Physical and Chemical Properties

Physical state and appearance: White to slight orange or green powder or crystal.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: 1.44
Melting point/freezing point: 290C to 300C literature.
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: Sparingly soluble in water and in propylene glycol, practically insoluble in anhydrous ethanol and in methylene chloride.
Viscosity: Not available.
Molecular Formula: C42H70O35 or (C6H10O5)7
Molecular Weight: 1134.98

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 and acids.
Polymerization: Will not occur.

Section 11: Toxicological Information
LD50 Oral - Rat: >10000 mg/kg.
LD50 Dermal – Rat: > 2.000 mg/kg.
LC50 Inhalation – Rat: 4 h - >= 4,9 mg/l
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.

Section 12: Ecological Information

Toxicity to fish: static test LC50 - Cyprinus carpio (Carp) - 7.561 mg/l  - 96 h.
Toxicity to daphnia and other aquatic invertebrates: Immobilization EC50 - Daphnia magna (Water flea) - > 100 mg/l  - 48 h.
BOD5 and COD: Not available.
Mobility: Not available.
Persistence and Degradability: No information available. However unlikely to persist.
Bioaccumulation/ Accumulation: No information available. However unlikely to accumulate.

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) & ADR/RID Europe: Not dangerous goods
IMDG: 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
California Prop 65: California No Significant Risk Level: None of the chemicals in this product are listed.

Section 16 - Additional Information

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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