Docusate sodium or Dioctyl sodium sulfosuccinate BP Ph Eur USP FCC Food GradeManufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Docusate sodium or Dioctyl sodium sulfosuccinate BP Ph Eur USP 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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Docusate sodium or Dioctyl sodium sulfosuccinate: CAS Number: 577-11-7, EINECS EC Number: 209-406-4, Molecular Formula: C20H37NaO7S, Molecular Weight: 444.56, HS Code ---**

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Docusate sodium or Dioctyl sodium sulfosuccinate.

Docusate or also known as docusate salts or dioctyl sulfosuccinate, is a laxative of the stool softener type used to treat constipation. Dioctyl sodium sulfosuccinate is approved for use in a variety of food products. It is approved for use as a surface-active agent, stabilizer, thickener, wetting agent, processing aid, solubilizing agent, emulsifying agent, and dispersing agent in foods. The highest amount found in food products is 0.5% by weight, which include pasteurized cheese spreads, cream, cheeses, and salad dressings. In food it is a thickener with E number of E480. The sodium salt, dioctyl sodium sulfosuccinate, also is used as a food additive, emulsifier, dispersant, and wetting agent, among other uses. Dioctyl sodium sulfosuccinate is used as a surfactant in a wide range of applications. It is also used as an excipient in pharmaceutical industry.

General Properties and Specifications of Docusate sodium or Dioctyl sodium sulfosuccinate:
Appearance: Colorless to white waxy solid.
Odor: Odorless.
Assay: 99% minimum.
Melting point: 153C to 157C literature.
Relative density: 1.1
Solubility: Slightly soluble in water. Soluble in alcohol and glycerin.

Specifications of Docusate Sodium USP Grade:
C20H37NaO7S --- 444.56
Butanedioic acid, sulfo-, 1,4-bis(2-ethylhexyl) ester, sodium salt;
Sodium 1,4-bis(2-ethylhexyl) sulfosuccinate --- 577-11-7.

DEFINITION
Docusate Sodium contains NLT 99.0% and NMT 100.5% of C20H37NaO7S, calculated on the anhydrous basis.

IDENTIFICATION
Procedure:
Sample: Place a small piece of Docusate Sodium on a salt plate, add one drop of acetone, and promptly cover with another salt plate. Rub the plates together to dissolve the specimen, slide the plates apart, and allow the acetone to evaporate.
Acceptance criteria: The IR absorption spectrum of the film exhibits maxima only at the same wavelengths as that of a similar preparation of USP Docusate Sodium.

ASSAY
Procedure:
Solution A: 2.5 g/L of tetra-n-butylammonium iodide in water
Solution B: A mixture of 100 g/L of anhydrous sodium sulfate and 10 g/L of sodium carbonate in water
Sample: 50 mg
Analysis: Dissolve the Sample in 50 mL of chloroform in a glass-stoppered, 250-mL conical flask. Add 50 mL of Solution B and 500 µL of bromophenol blue TS. Titrate with Solution A until 1 mL from the endpoint, and shake the stoppered flask vigorously for 2 min. Continue the titration in two-drop increments, shaking vigorously for 10 s after each addition, and then allow the flask to stand 10 s. Continue the titration until the chloroform layer just assumes a blue color. Each mL of Solution A is equivalent to 3.009 mg of C20H37NaO7S.
Acceptance criteria: 99.0%–100.5% on the anhydrous basis

Residue on Ignition: Between 15.5% and 16.5%, calculated on the anhydrous basis
To pass the test.
Acceptance criteria: NMT 0.4%
Water Determination: NMT 2.0%
Clarity of Solution:
Sample solution: 25 g in 100 mL of alcohol
Acceptance criteria: The Sample solution does not develop a haze within 24 h.
Packaging and Storage: Preserve in well-closed containers.

Specifications of Docusate Sodium BP Ph Eur Grade:
Dioctyl Sodium Sulphosuccinate
C20H37NaO7S --- 444.6 --- 577-11-7
Action and use: Stimulant laxative; faecal softener.

DEFINITION
Sodium 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxobutane-2-sulfonate.
Content: 98.0 to 101.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white, waxy masses or flakes, hygroscopic.
Solubility: Sparingly soluble in water, freely soluble in ethanol (96 per cent) and in methylene chloride.

IDENTIFICATION
A. Infrared absorption spectrophotometry.
Preparation Place about 3 mg of the substance to be examined on a sodium chloride plate, add 0.05 mL of acetone and immediately cover with another sodium chloride plate. Rub the plates together to dissolve the substance to be examined, slide the plates apart and allow the acetone to evaporate.
Comparison docusate sodium CRS.
B. In a crucible, ignite 0.75 g in the presence of dilute sulfuric acid, until an almost white residue is obtained. Allow to cool and take up the residue with 5 mL of water. Filter. 2 mL of the filtrate gives reaction (a) of sodium.

TESTS
Alkalinity: Dissolve 1.0 g in 100 mL of a mixture of equal volumes of methanol and water, previously neutralised to methyl red solution. Add 0.1 mL of methyl red solution. Not more than 0.2 mL of 0.1 M hydrochloric acid is required to change the colour of the indicator to red.
Related non-ionic substances: To pass the test by Gas chromatography.
Limits: test solution (a):
-any impurity: for each impurity, not more than the area of the peak due to the internal standard (0.4 per cent).
Chlorides: Maximum 350 ppm.
Sodium sulfate: Maximum 2 per cent.

Specifications of Dioctyl Sodium Sulfosuccinate FCC Food Grade:
DOSS; Docusate Sodium
C20H37NaO7S Formula wt 444.56
INS: 480 CAS: [577-11-7]

DESCRIPTION
Dioctyl Sodium Sulfosuccinate occurs as a white, wax-like, plastic solid. One gram of sample dissolves slowly in about 70 mL of water. It is freely soluble in alcohol and in glycerin, and it is very soluble in solvent hexane.
Function: Emulsifier; wetting agent.

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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Docusate sodium or Dioctyl sodium sulfosuccinate or DOSS SDS, Safety Data Sheet
MSDS, Material Safety Data Sheet 17-Oct-20

Product Name & Other Names: Docusate sodium or Dioctyl sodium sulfosuccinate or DOSS.
CAS Number: 577-11-7
EINECS EC Number: 209-406-4
Molecular Formula: C20H37NaO7S
Molecular Weight: 444.56
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Supplier: As per the letterhead.

GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008

Skin corrosion/irritation (Category 2) H315
Serious eye damage (Category 1) H318

Hazard statements:
H315: Causes skin irritation.
H318: Causes serious eye damage.

Precautionary statements:
P261: Avoid breathing dust/ fume/ gas/ mist/ vapors/ spray.
P262: Do not get in eyes, on skin, or on clothing.
P264 Wash skin thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P273: Avoid release to the environment.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P330: Rinse mouth.
P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P302+P352: IF ON SKIN: Wash with soap and water.
P304+340: 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.
P314: Get Medical advice/attention if you feel unwell.
P337+P313: If eye irritation persists: Get medical advice/ attention.
P501: Dispose of contents/ container to an approved waste disposal plant.

Classification according to European Directive 67/548/EEC as amended:
Hazard symbols:
Xi Irritant
C Corrosive
R-phrases:
R34 Causes burns.
R38 Irritating to skin.
R41 Risk of serious damage to eyes.

Product Name & Other Names: Docusate sodium or Dioctyl sodium sulfosuccinate or DOSS.
CAS Number: 577-11-7
EINECS EC Number: 209-406-4

Eye Contact: Do not allow victim to rub eye (s). Let the eye (s) water naturally for a few minutes. If particle/dust does not dislodge, flush with lukewarm, gently flowing water for 5 minutes or until particle/dust is removed, while holding eyelid (s) open. If irritation persists, obtain medical attention. DO NOT attempt to manually remove anything stuck to the eye.
Skin Contact: Remove contaminated clothing, shoes and leather goods (e.g. watchbands, belts). Quickly and gently blot or brush away excess chemical. Wash gently and thoroughly with lukewarm gently flowing water and non-abrasive soap for 5 minutes. If irritation persists, repeat flushing. Obtain medical advice. Completely decontaminate clothing, shoes and leather goods before reuse or else discard.
Inhalation: If symptoms are experienced, remove source of contamination or move victim to fresh air. Obtain medical advice.
Ingestion: Never give anything by mouth if victim is rapidly losing consciousness or is unconscious or convulsing. Have victim rinse mouth thoroughly with water. DO NOT INDUCE VOMITING.

Flash Point: 170C
Fire and Explosion Hazards: Will burn on heating.
Extinguishing Media: Use means of extinction appropriate for the surrounding fire conditions such as water spray, carbon dioxide, dry chemical, or foam.
Fire Fighting: Apart from oxides of carbon. toxic fumes of sulfur dioxide and undefined fumes may result from combustion. Closed containers may explode from heat of a fire. As with any fire, fire fighters should be fully trained and wear full protective clothing including an approved, self-contained breathing apparatus which supplies a positive air pressure within a full-face piece mask. Do not use water directly on material. Do not allow water run-off to enter sewers or watercourses. Use water spray to cool unopened containers.
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.

Procedures for Cleanup: Stop release if possible to do so safely. Contain spill, isolate hazard area, and deny entry. Sweep up or vacuum. Place contaminated material in suitable, labeled containers for final disposal. Dispose of waste material consistent with the requirements of waste disposal authorities.
Personal Precautions: Gloves and coveralls or other protective clothing are recommended for persons responding to an accidental release. Close-fitting safety goggles may be necessary in some circumstances to prevent eye contact.
Environmental Precautions: Contamination of soil and water should be prevented. Keep spillage and runoff from storage areas from entering soil, streams or sewers.

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: Keep away from sources of ignition - No smoking. Take measures to prevent the build-up of electrostatic charge. 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. generating dust and the release of dust into the workplace. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid contact with skin and eyes. 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.
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: Colorless to white waxy solid.
Odor: Odorless.
Odor threshold: Not available.
pH: 5.5 to 10.5 @ 10% solution.
Relative density: around 1.1
Melting point/freezing point: 153C to 157C 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(ies): Slightly soluble in water. Soluble in alcohol and glycerin.
Viscosity: Not available.
Molecular Formula: C20H37NaO7S
Molecular Weight: 444.56

Stability and Reactivity: Stable and not considered reactive under normal temperatures and pressures. Hazardous polymerization or runaway reactions will not occur.
Incompatibilities: Oxidizing agents. Avoid excessive heat.
Hazardous Decomposition Products: High temperature operations will generate carbon oxide and fumes. Under such conditions, sulfur dioxide will also be generated and can cause respiratory distress.

Acute Toxicity:
LD50 Oral - Rat - male and female: >3000 mg/kg.
LD50 Dermal - Rabbit – male: > 10.000 mg/kg
Carcinogenicity: IARC: No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Eco toxicological data:
Toxicity to fish: LC50 - Danio rerio (zebra fish) - 49 mg/l - 96 h.
Toxicity to daphnia and other aquatic invertebrates: static test EC50 - Daphnia magna (Water flea) - 10,3 mg/l - 48 h.
Persistence and Degradability: Soluble in water Persistence is unlikely based on information available.
Bioaccumulation/ Accumulation: No information available.
Mobility: Will likely be mobile in the environment due to its water solubility.

Do not wash the material down drain. Put uncontaminated material back into the process if possible. Place contaminated material in suitable, labeled containers for disposal. Dispose of waste material consistent with the requirements of waste disposal authorities.

DOT USA & ADR/RID Europe: Not regulated.
IATA: Not regulated.
IMDG: Not regulated.
IMDG/IMO: Not regulated.

USA Regulations:
SARA 302 Components: No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313 Components: 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.
SARA 311/312 Hazards: Acute Health Hazard, Chronic Health Hazard.
California Prop. 65 Components: This product does not contain any chemicals known to State of California to cause cancer, birth defects, or any other reproductive harm.

European Labeling in Accordance with EC Directives:
H315: Causes skin irritation.
H318: Causes serious eye damage.
Classification according to European Directive 67/548/EEC as amended:
Hazard symbols:
Xi Irritant
C Corrosive
R-phrases:
R34 Causes burns.
R38 Irritating to skin.
R41 Risk of serious damage to eyes.

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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