Hydroxypropyl Betadex or HPBCD or 2- Hydroxypropyl-Beta-Cyclodextrin Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Hydroxypropyl beta cyclodextrin or Hydroxypropylbetadex, 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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Hydroxypropyl beta cyclodextrin or Hydroxypropylbetadex or Hydroxypropyl Betadex or Hydroxy propyl betacyclodextrine or 2-Hydroxypropyl-β-cyclodextrin: CAS Number: 128446-35-5 or 94035-02-6, EINECS EC Number: 420-920-1, Molecular Formula: C42H70O35-(C3H6O)n where n = 7 × MS, MS being molar substitution, Molecular Weight: 1134.98+58n, HS Code ---**

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Hydroxypropyl beta cyclodextrin or Hydroxypropylbetadex or Hydroxypropyl Betadex or Hydroxy propyl betacyclodextrine or 2-Hydroxypropyl-β-cyclodextrin or HPBCD or 2- Hydroxypropyl-Beta-Cyclodextrin.

Hydroxypropyl-beta-cyclodextrin in pharmaceuticals industry, can increase solubility and bioavailability of insoluble drugs, so that the efficacy of drugs can last longer with less ingestion of drugs. It is generally used in medicine, food, cosmetics.

General Properties and Specifications of Hydroxypropyl beta cyclodextrin or Hydroxypropylbetadex or Hydroxypropyl Betadex or Hydroxy propyl betacyclodextrine or 2-Hydroxypropyl-β-cyclodextrin:
Appearance (Color): White Powder
Assay (HPLC): 99% minimum on drybasis.
Moisture content: As agreed.
Residue on ignition: 2% maximum.
Heavy metal (Pb): 0.0025% maximum.
Arsenic (As): 0.0002% maximum.
Solubility: ≥ 100 g/100ml @25.

Specifications of Hydroxypropyl Betadex USP NF Grade:
C42H70O35 (C3H6O)x where x = 7 × MS, MS being molar substitution
Beta cyclodextrin, 2-hydroxypropyl ether --- [CAS 94035-02-6].

DEFINITION
Hydroxypropyl Betadex is a partially substituted poly(hydroxypropyl) ether of Betadex. The number of hydroxypropyl groups per anhydroglucose unit expressed as molar substitution (MS) is NLT 0.40 and NMT 1.50 and is within 10% of the value stated on the label.

IDENTIFICATION
A. Infrared Absorption: The spectrum obtained with Hydroxypropyl Betadex shows the same absorption bands as the spectrum acquired with USP Hydroxypropyl Betadex RS. Due to the difference in the substitution of the substance, the intensity of some absorption bands may vary.
B. It meets the requirements of the test for Clarity of Solution.

ASSAY
To pass the test.
Acceptance criteria: 0.40–1.50 and within 10% of the value stated on the label

Limit of Betadex, Propylene Glycol, and Other Related Substances:
To pass the test by Chromatography.
Limit of Propylene Oxide:
To pass the test by Chromatography.
Acceptance criteria: NMT 0.0001%
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.
Loss on Drying:
Sample: 1 g
Analysis: Dry the Sample at 20C for 2 h.
Acceptance criteria: NMT 10.0%
Clarity of Solution:
Sample: 1.0 g
Analysis: Dissolve the Sample in 2.0 mL of water, and heat.
Acceptance criteria: The resulting solution is clear and remains transparent after cooling to room temperature.
Bacterial Endotoxins Test: The level of bacterial endotoxins is such that the requirement under the relevant dosage form monograph(s) in which Hydroxypropyl Betadex is used can be met. Where the label states that Hydroxypropyl Betadex must be subjected to further processing during the preparation of injectable dosage forms, the level of bacterial endotoxins is such that the requirement under the relevant dosage form monograph(s) in which Hydroxypropyl Betadex is used can be met.
Sterility Tests: Where the label states that Hydroxypropyl Betadex is sterile, it meets the requirements for Sterility Tests in the relevant dosage form monograph(s) in which Hydroxypropyl Betadex is used.
Conductivity:
Acceptance criteria: NMT 200 microS/cm
Packaging and Storage: Preserve in well-closed containers. Store at room temperature.
Labeling: Label it to indicate the molar substitution (MS). Where Hydroxypropyl Betadex is intended for use in the manufacture of injectable dosage forms, it is so labeled. Where Hydroxypropyl Betadex must be subjected to further processing during the preparation of injectable dosage forms to ensure acceptable levels of bacterial endotoxins, it is so labeled. Where Hydroxypropyl Betadex is sterile, it is so labeled.

Specifications of Hydroxypropylbetadex BP Ph Eur grade:
C42H70O35(C3H6O) with x = 7 MS
Action and use: Excipient.

DEFINITION
Hydroxypropylbetadex (β-cyclodextrin, 2-hydroxypropyl ether) is a partially substituted poly(hydroxypropyl) ether of betadex.
Content: Hydroxypropyl groups per anhydroglucose unit, expressed as molar substitution (MS): 0.40 to 1.50 and content within 10 per cent of the value stated on the label.

CHARACTERS
Appearance: White or almost white, amorphous or crystalline powder.
Solubility: Freely soluble in water and in propylene glycol.

IDENTIFICATION
A. Infrared absorption spectrophotometry.
Comparison hydroxypropylbetadex CRS.
Results The spectrum obtained with the substance to be examined shows the same absorption bands as the spectrum obtained with hydroxypropylbetadex CRS. Due to differences in the substitution of the substance, the intensity of some absorption bands can vary.
B. Appearance of solution (see Tests).

TESTS
Solution S: Dissolve 5.0 g in carbon dioxide-free water prepared from distilled water and dilute to 50.0 mL with the same solvent.
Appearance of solution: The solution is clear and colourless, and remains so after cooling to room temperature.
Dissolve 5.0 g in 10.0 mL of water, with heating.
Conductivity: Maximum 200 microS/cm.
Measure the conductivity of solution S, while gently stirring with a magnetic stirrer.
Related substances:
To pass the test by liquid chromatography.
Limits:
-impurity A: maximum 1.5 per cent;
-sum of impurities other than A: maximum 1.0 per cent;
-reporting threshold: 0.05 per cent; disregard any peak eluting after impurity A.
Impurity B
To pass the test by gas chromatography.
Limit:
-impurity B: maximum 2.5 per cent.
Loss on drying: Maximum 10.0 per cent, determined on 1.000 g by drying in an oven at 120 °C for 2 h.
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 1002 CFU/g;
-absence of Escherichia coli;
-absence of Salmonella.
Bacterial endotoxins: Less than 10 IU/g, if intended for use in the manufacture of parenteral preparations without a further appropriate procedure for the removal of bacterial endotoxins.

LABELLING
The label states:
-the molar substitution (MS);
-where applicable, that the substance is suitable for use in the manufacture of parenteral preparations.

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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Hydroxypropyl Betadex or HPBCD or 2- Hydroxypropyl-Beta-Cyclodextrin SDS GHS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 23-Oct-20

Product Name & Other Names: Hydroxypropyl Betadex or HPBCD or 2- Hydroxypropyl-Beta-Cyclodextrin.
CAS Number: 128446-35-5
EINECS EC Code: 420-920-1
Molecular Formula: C42H70O35 (C3H6O)x where x = 7 × MS, MS being molar substitution
Molecular Weight: --
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: Hydroxypropyl Betadex or HPBCD or 2- Hydroxypropyl-Beta-Cyclodextrin.
CAS Number: 128446-35-5
EINECS EC Code: 420-920-1

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.

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 or almost white, amorphous or crystalline powder.
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: Freely soluble in water and in propylene glycol.
Viscosity: Not available.
Molecular Formula: C42H70O35 (C3H6O)x where x = 7 × MS, MS being molar substitution
Molecular Weight: --

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: > 2200 mg/kg.
LD50 Dermal – Rat: > 2.000 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: LC50 - Danio rerio (zebra fish) - > 1.131 mg/l - 96 h.
Toxicity to daphnia and other aquatic invertebrates: EC50 - Daphnia magna (Water flea) - > 1.084 mg/l - 48 h.
BOD5 and COD: Not available.
Mobility: Likely to be mobile due to 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: 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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