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Vaseline

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Pharmaceutical Excipients

Vaseline

White Petrolatum (also known as Petrolatum or Petroleum Jelly) is a translucent, odorless, semi-solid Ointment Base consisting of a purified blend of high molecular weight saturated hydrocarbons. Petrolatum is one of the most essential excipients in dermatological and topical formulations, primarily functioning as an Occlusive Agent to create a protective barrier on the skin that prevents water loss ($\text{Trans-epidermal Water Loss - TEWL}$). It is also widely used as a Chemically Inert Ointment Base.

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:
Ointment Base, Occlusive/Protectant Agent, Emollient.
Chemical Composition:
A blend of liquid and semi-solid saturated hydrocarbons.
Solubility:
Immiscible with water and ethanol; soluble in ether, chloroform, and petroleum oils..
Mechanism of Action:
As a Barrier : Forms an impermeable (Hydrophobic) fatty layer on the skin's surface, significantly reducing water loss and maintaining skin hydration.
As a Base : Provides a stable fatty medium for the dispersion of lipid-soluble APIs or water-sensitive materials.
Stability : Exhibits excellent chemical and physical stability, making it resistant to oxidation and degradation.
Ointments and Protectants

Burn ointments, skin protective formulations, and ophthalmic ointments.

Offers long-lasting protection and a superior water barrier with minimal irritation.

Creams and Emulsions

Part of the Oil Phase in the preparation of water-in-oil (W/O) emulsions.

Contributes to emulsion stability and enhances the final product's occlusive properties.

Tablet/Capsule Manufacturing

Occasionally used as an external Lubricant in specific manufacturing processes.

Works to lubricate press surfaces to prevent powder sticking.

Regulatory Compliance

The product fully complies with the requirements specified in the United States Pharmacopeia (USP) (as $\text{White Petrolatum}$), the European Pharmacopoeia (EP), and/or other relevant standards.

Critical Tests

Rigorous testing of Melting Range and Viscosity to ensure consistency in the semi-solid physical properties of the product.

Purity and Impurity Control

The product is tested to ensure freedom from volatile organic impurities and any harmful particulates (critical for ophthalmic use).

Manufacturing Operations

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

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