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Mannitol

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Pharmaceutical Excipients

Mannitol

Mannitol is a hexahydric Sugar Alcohol (polyol) occurring as a white, crystalline powder. It is one of the most widely preferred excipients globally for solid dosage form manufacturing due to its Non-hygroscopic nature (it does not readily absorb moisture) and exceptional chemical stability. Mannitol is characterized by a cool, sweet taste (approximately 50% the sweetness of sucrose) and excellent compression properties, making it the primary choice for chewable tablets and Orally Disintegrating Tablets (ODTs).

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 Category:
Filler/Diluent, Sweetening Agent, and Disintegrant aid.
Chemical Structure:
(Hexane-1,2,3,4,5,6-hexol)..
Thermal Effect:
Possesses a Negative heat of solution, providing a distinct cooling sensation and refreshing mouthfeel.
Solubility:
Soluble in water; slightly soluble in ethanol and practically insoluble in organic solvents.
Chewable Tablets

Vitamins, antacids, and pediatric medications.

The sweet taste and cooling effect significantly improve patient compliance and palatability.

Orally Disintegrating Tablets (ODTs)

Medications requiring rapid onset or waterless administration.

Facilitates rapid tablet disintegration in the oral cavity..

Moisture-Sensitive Formulations

Capsules and tablets containing hydrolytically unstable APIs.

Its non-hygroscopic nature protects sensitive APIs from degradation caused by ambient moisture.

Parenteral Solutions

Osmotic diuretics.

Used in specific concentrations as a treatment for cerebral edema and increased intraocular pressure.

Regulatory Compliance

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

Particle Size Distribution

Optimized grades available (e.g., DC-grade) to ensure superior flowability and weight uniformity in high-speed tablet presses.

Chemical Purity

Stringent monitoring of reducing sugars and impurities to prevent discoloration or chemical interactions over the product's shelf life.

Allergen-Free

Non-GMO, gluten-free, and BSE/TSE compliant.

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