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Glycerin

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Pharmaceutical Excipients

Glycerin

Glycerin, also known as Glycerol, is a clear, colorless, odorless, sweet-tasting, liquid Trihydric Alcohol (a compound with three hydroxyl groups). It is a natural byproduct of the soap manufacturing process or the hydrolysis of fats. Glycerin is one of the most important excipients in the pharmaceutical and cosmetic industries, primarily functioning as a Solvent, a Potent Humectant (preventing products from drying out), and an Emollient in topical formulations. It is a key agent in improving the texture, palatability, and stability of solutions and semi-solid products.

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:
Solvent, Humectant, Emollient, Viscosity Modifier.
Chemical Structure:
$\text{Propane-1,2,3-triol}$ ($\text{C}_3\text{H}_8\text{O}_3$).
Solubility:
Completely miscible with water and ethanol, immiscible with hydrocarbon oils.
Mechanism of Action:
As a Humectant : Its high capacity to draw and retain moisture from the air prevents the desiccation of films and solutions..
As a Solvent : Used as a cosolvent to increase the solubility of many hydrophobic APIs.
As an Emollient : Applied topically to soften and soothe the skin and mucous membranes.
Oral Solutions

Syrups, oral rinses, and dropper solutions..

Acts as a sweetener, solvent, and viscosity stabilizer to prevent component separation.

Topical and Dermal Preparations

Creams, ointments, and medicinal films.

Enhances moisture, improves product texture, and aids in emulsification.

Suppositories

Used as a water-soluble suppository base, often in conjunction with other materials.

Blends well with fast-dissolving bases (e.g., PEG).

Soft Gel Capsules

Key ingredient in the capsule shell.

Imparts flexibility and durability to the shell..

Regulatory Compliance

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

Purity and Impurity Control

Strict control over Glycerol purity, focusing on minimizing the content of toxic impurities such as Diethylene Glycol (DEG), chlorides, and fatty substances.

Chemical Determination

Accurate determination of Specific Gravity to confirm concentration and purity.

Manufacturing Operations

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

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