Docusate Sodium USP
Active Ingredient for Laxatives & Stool Softeners
A p p l i c a t i o n B u l l e t i n |
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| Docusate sodium USP (DSS) is used extensively in stool softener
formulations to provide consistent, predictable, and gentle relief. This
highly effective and versatile anionic surfactant (surface active agent)
is used as an active ingredient in a variety of combination
laxative/stool softener formulations. Cytec’s pharmaceutical-grade
DSS products are manufactured to the highest quality standards
under cGMP, and offer exceptional quality and performance as both
active ingredients and as excipients. |
Applications
In addition to being used as a formulating aid (excipient) in oral dosage
forms, DSS is particularly effective as an active ingredient in:
- Laxatives & stool softeners – for prevention and treatment of
various types of constipation
- Prenatal & geriatric vitamin preparations – to overcome
constipation induced by iron salts
- Colon cleansing aids – in preparation of a patient for X-ray
examination or surgery
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Features
- Pharmaceutical grade, manufactured under cGMP; EP and USP
compliant
- Virtually free from adverse reactions when used in recommended
doses
- Effective alone or in combination with peristaltic stimulants and
bulking agents
- 3 product forms: 100%, 85% granular, 50% in PEG
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Benefits
- Meets standards of quality, strength, purity, and potency recognized
worldwide
- Causes the least possible disturbance of normal body physiology;
non habit-forming
- Allows ability to optimize formulations and enhance performance
results
- Multiple product types provide flexibility in handling and ease of use
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| Timing index of stool softening with DSS |
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P r o d u c t I n f o r m a t i o n |
Docusate Sodium USP (DSS) |
Composition
DSS is the dioctyl ester of sodium sulfosuccinate (bis-2-ethylhexyl sodium sulfosuccinate). |
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| Typical Properties |
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| Products |
100% DSS |
85% DSS granular
with sodium benzoate |
50% DSS in
polyethylene glycol |
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STORAGE
DSS should be stored in tightly closed containers at temperatures below 75°F (24°C)
with relative humidity of less than 60%. Higher temperatures may cause the 100%
material to fuse and discolor.
HEALTH AND SAFETY INFORMATION
Direct contact may cause eye or skin irritation. Sodium dioctyl sulfosuccinate has acute
oral LD50 values for the rat and mouse of 1,900-4,000 mg/kg and 2,640 mg/kg, respectively.
Acute dermal (rabbit) LD50 value is greater than 10,000 mg/kg. Read the Cytec
Industries Inc. Material Safety Data Sheet on this product, before using, for detailed
safety and handling information. The Material Safety Data Sheet is available and is
routinely provided at the time of first shipment of this product. |
IMPORTANT NOTICE
The information and statements herein are believed to be reliable, but are not to be
construed as a warranty or representation for which we assume legal responsibility or as
an assumption of a duty on our part. Users should undertake sufficient verification and
testing to determine the suitability for their own particular purpose of any information,
products, or vendors referred to herein. NO WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE IS MADE. Nothing herein is to be taken as permission,
inducement or recommendation to practice any patented invention without a license. |
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