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for Active Substance to be imported into European Union (EU).Docusate Sodium or Dioctyl Sodium Sulfosuccinate USP BP Ph Eur FCC Food Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Docusate Sodium or Dioctyl Sodium Sulfosuccinate and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.
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Docusate Sodium or Dioctyl Sodium Sulfosuccinate SDS of Manufacturers
Synonyms: Docusate Sodium or Dioctyl Sodium Sulfosuccinate
CAS Number: 577-11-7, Molecular Weight: 444.56, Chemical Formula: C20H37NaO7S, EINECS EC Number: 209-406-4, FEMA: ----,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 basisResidue 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.
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 weight 444.56
INS: 480 CAS 577-11-7DESCRIPTION
REQUIREMENTS
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.
Identification: The infrared absorption spectrum of a film of the sample between two salt plates exhibits relative maxima at the same wavelengths as those of a similar preparation of USP Docusate Sodium Reference Standard.
Assay: Not less than 98.5% of C20H37NaO7S, calculated on the dried basis.
Bis(2-ethylhexyl)maleate: Not more than 0.4%.
Clarity of Solution: Passes test.
Lead: Not more than 2 mg/kg.
Loss on Drying: Not more than 2.0%.
Residue on Ignition: Between 15.5% and 16.2%.Keywords: Docusate Sodium or Dioctyl Sodium Sulfosuccinate IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 577-11-7 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
Manufacturer Supplier Exporter
ANMOL CHEMICALS
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Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIAe-mail: info@anmol.org
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Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.
All products are Sold for Industrial and Laboratory Use only. No other use is permitted.
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