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DOCUSATE SODIUM USP / BP/ PH.EUR
CAS NO: 557 - 11 - 7 / 78207-03-1
ChemicalFormula: C20H37NaO7S
Molecular Weight : 444.56
SYNONYMS: Sodium 1,4-bis[(2-ethylhexyl)oxy]-1,4-dioxo-2-butanesulfonate / DOSS / DSS / Dioctyl Sodium Sulphosuccinate / Dioctyl Sodium Sulfosuccinate / NatriDocusas / Aerosol OT / AOT / 1,4-Bis(2-Ethylhexyl) Sodium Sulfosuccinate / 2-Ethylhexyl Sulfosuccinate Sodium / Bis(2-Ethylhexyl) Sodium Sulfosuccinate / Bis(2-Ethylhexyl) Sodium Sulfosuccinate / Bis(2-Ethylhexyl) S-Sodium Sulfosuccinate / Bis(2-Ethylhexyl) Sulfosuccinate Sodium Salt / Bis(2-Ethylhexyl)Sodium Sulfosuccinate / NatriDocusas / Sulfosuccinic Acid, Bis(2-Ethylhexyl)Ester Sodium Salt
DOCUSATE SODIUM USP
| TESTS | SPECIFICATIONS & LIMITS |
| Description | White, wax-like, plastic solid, having a characteristic odor suggestive of octyl alcohol, but no odor of other solvents. |
| Solubility | Sparingly soluble in water, very soluble in solvent hexane, freely soluble in alcohol and in glycerin. |
| Identification | Infrared absorption spectrum of sample should be concordant with the reference spectrum of USP Docusate Sodium reference working standard. |
|
Assay (on the anhydrous basis) |
Not less than 99.0% and Not more than 100.5% |
| IMPURITIES | |
|
Inorganic Impurities Residue on ignition (on the anhydrous basis) Heavy metals |
Between 15.5% and 16.5%
Not more than 10 ppm |
|
Organic Impurities Limit of Bis (2-Ethylhexyl) Maleate |
Not more than 0.4% |
SPECIFIC TESTS
|
Water content Clarity of solution |
Not more than 2.0% 25 gm dissolved in 100 ml of alcohol. The sample solution does not develop a haze within 24 hours. |
DOCUSATE SODIUM BP
| CHARACTERS | SPECIFICATIONS & LIMITS |
| 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) Should comply Infrared absorption spectrum B) The filtrate gives reaction (a) of sodium |
TESTS
| Alkalinity | Not more than 0.2 ml |
| Related non - ionic substances | Not more than 0.4 per cent |
| Chlorides | Maximum 350 ppm |
| Sodium Sulphate | Maximum 2 per cent |
| Heavy metals | Maximum 10 ppm |
| Water | Maximum 3.0 per cent |
|
Assay (anhydrous substance) |
98.0 to 101.0 per cent |
DOCUSATE SODIUM 85% - POWDER (Docusate Sodium USP/BP 85% with Sodium Benzoate NF 15%)
| TESTS | SPECIFICATIONS & LIMITS |
| Description | White to almost white, crystalline powder, hygroscopic. |
| Identification | The Infrared absorption spectrum of the film exhibits maxima at the same wavelengths as that of a similar preparation of Docusate Sodium reference working standard. |
| Water content | Not more than 2.0% |
| Residue on Ignition | Between 19% and 23% |
| Arsenic | Not more than 3 ppm |
| Heavy Metals | Not more than 10 ppm |
| Limit of Bis(2 Ethylhexyl ) maleate | Not more than 0.4% |
|
Assay Docusate Sodium (on the anhydrous basis) |
Not Less than 83 % |
|
Assay Sodium Benzoate (on the anhydrous basis) |
Not More than 17 % |
DOCUSATE SODIUM USP/BP 50 % with Polyethylene Glycol 400
| TESTS | SPECIFICATIONS & LIMITS |
| Description | White to yellow, clear, viscous liquid, free from suspended particles. |
| Water content | Not more than 2.0% |
| Specific Gravity @ 25°C | 1.11g – 1.15g |
| Heavy Metals | Not more than 10 ppm |
|
Assay (on the anhydrous basis) |
Not Less than 48.5% - Not more than 51.5% |
DOCUSATE SODIUM USP/BP 75 % with Isopropyl Alcohol (IPA)
| TESTS | SPECIFICATIONS |
| Description | White to almost white, clear, viscous liquid, free from suspended solids |
| Specific Gravity @ 25°C | 1.00 - 1.20g |
| Heavy Metals | Not more than 10 ppm |
| Assay Docusate Sodium | Not Less than 74% |
- Docusate Sodium
- Docusate Sodium Powder
- Dioctyl Sodium Sulphosuccinate
