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Sorbitol

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Pharmaceutical Excipients

Sorbitol

Sorbitol is a polyhydric sugar alcohol, typically obtained by the reduction of glucose. It is one of the most important multifunctional excipients in the pharmaceutical and nutritional industries, primarily used as a Sweetener (non-cariogenic), a Humectant to prevent formulations from drying out, and a Diluent in compressed tablets. Sorbitol is also known for its ability to act as a mild Laxative at higher doses. It is available either as a crystalline powder or a 70% aqueous solution (Sorbitol Solution).

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).
A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.
A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.
Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).
Functional Class:
Sweetener, Humectant, Diluent (Filler), Laxative.
Chemical Structure:
$\text{D-glucitol}$ or $\text{D-sorbitol}$ ($\text{C}_6\text{H}_{14}\text{O}_6$).
Mechanism of Action:
As a Sweetener : Provides a sweet taste, ranging from 50% to 60% the sweetness of sucrose, with a noticeable cooling effect in the mouth.
As a Humectant : Absorbs and retains moisture, which prevents tablets from hardening or ointments from drying out.
As a Laxative : Draws water into the gastrointestinal tract, increasing stool bulk and softening.
Optimal Use:
Ideal for chewable formulations that require good palatability and stability against moisture.
Crystalline Powder

Compressed Tablets, Chewable Tablets, Capsules.

Functions as a compressible diluent that imparts hardness to tablets.

70% Aqueous Solution

Syrups, Oral Rinses, Toothpastes, and Ointments.

Used as a humectant, a viscosity stabilizer, and a texture enhancer in liquid formulations.

Lozenges/Troches

Lozenges and pastilles.

Provides sweetness and a cooling sensation with an extended dissolution time.

Regulatory Compliance

The product fully complies with the requirements specified in the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), and/or other food/supplementary standards (FCC).

Sorbitol Content (Assay)

Strict control over sorbitol content to ensure consistency in functional and sweetening properties.

Impurities

Accurate determination of residual sugars (e.g., glucose) and solvents.

Manufacturing Operations

Production is conducted in a rigorous cGMP environment, ensuring consistency in physicochemical properties.

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