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Aspartame

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Pharmaceutical Excipients

Aspartame

Aspartame is a High-Intensity Artificial Sweetener, a dipeptide compound composed of aspartic acid and phenylalanine. It is one of the most important sugar substitutes in pharmaceutical formulations, offering superior sweetness up to 200 times that of sucrose with a negligible caloric contribution. Aspartame is primarily used to enhance the palatability of drugs, particularly those with a bitter or unpleasant taste, and is a key ingredient in compressed, chewable tablets, and oral solutions.Aspartame is a High-Intensity Artificial Sweetener, a dipeptide compound composed of aspartic acid and phenylalanine. It is one of the most important sugar substitutes in pharmaceutical formulations, offering superior sweetness up to 200 times that of sucrose with a negligible caloric contribution. Aspartame is primarily used to enhance the palatability of drugs, particularly those with a bitter or unpleasant taste, and is a key ingredient in compressed, chewable tablets, and oral solutions.

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:
High-Intensity Sweetener, Flavoring Agent.
Chemical Structure:
$\text{N-L- } \alpha \text{-aspartyl-L-phenylalanine methyl ester}$
Sweetening Power:
$\sim 200$ times sweeter than Sucrose..
Mechanism of Action:
As a Sweetener : Provides an immediate and clean sweetness profile similar to sugar, thereby improving patient compliance.
Stability : Shows good stability under dry conditions. Requires careful consideration in liquid formulations with high $\text{pH}$ or high temperatures (it hydrolyzes into diketopiperazine).
Optimal Use : Ideal for chewable formulations, orally disintegrating tablets (ODTs), and liquid medications requiring potent sweetening at a small dose.
:
Oral Tablets

Chewable tablets, effervescent tablets, and lozenges.

Requires a very low dose for desired sweetness, minimizing tablet size.

Solutions and Syrups

Liquid medicines for adults and pediatrics.

Used at low concentrations to improve taste without significantly increasing viscosity or caloric load.

Powders and Blends

Dry powder blends and sachets.

Blends well with other diluents and flavoring agents.

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).

Sweetening Power and Purity

Rigorous testing on Aspartame purity and sweetening intensity.

Stability

Close monitoring for degradation products (such as $\text{DKP}$ - Diketopiperazine) to ensure quality.

Manufacturing Operations

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

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