Pharmacopeial Specifications
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Identification: Complies with pharmacopeial standards
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Solubility: Soluble in water, forming a colloidal solution; insoluble in organic solvents
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pH (1% solution): 8.0–10.0
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Loss on Drying: ≤5.0%
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Heavy Metals: ≤0.002%
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Residual Solvents: Complies with regulatory limits
Applications in Pharmaceutical Formulation
Sodium stearate functions as a lubricant, emulsifier, and stabilizer in pharmaceutical formulations. It is used in topical preparations, tablet formulations, and suppositories, enhancing the spreadability and texture of creams and lotions while providing structural integrity in solid dosage forms.
Comments
Sodium stearate is a well-tolerated excipient with a long history of safe use. Its surfactant properties make it useful in various formulations, though it may interact with certain drug compounds, potentially affecting dissolution rates.
