+91 84258 80640 export@saliuspharma.com

Product Overview

Aspartame is used as a sweetener that provides sweetness without adding significant calories. It is also used as a flavor enhancer that helps mask bitterness or unpleasant taste of some APIs.

Product Type: Pharmaceutical Excipient

Chemical Name L-alpha-Aspartyl-L-phenylalanine methyl ester
Chemical Formula C₁₄H₁₈N₂O₅
CAS Number 22839-47-0
Molecular Weight 294.30 g/mol
Application Role Sweetening agent and flavor enhancer in pharmaceutical, nutraceutical, and food formulations
Regulatory Compliance IP / BP / USP-NF / EP
Manufacturing Suitability Suitable for oral solid and liquid dosage forms; not suitable for heat-intensive processes
Storage Conditions Store in a cool, dry place preferably below 25°C; protect from moisture and light
Certifications cGMP, ISO, USP / Ph. Eur
Availability Widely available globally from chemical distributors, excipient manufacturers, and ingredient suppliers in bulk and pharma-grade packaging
HS Code 29242990

Excipient Technical Profile

Appearance White or off-white crystalline powder
Bulk Density 0.35 – 0.55 g/cm³
Solubility Slightly soluble in water; insoluble in ethanol
pH (1% aqueous solution) 4.3 – 5.0

Typical Applications

Key Benefits

High sweetness intensity
Compatible with various dosage forms
Low-calorie
Rapid dissolution
Improves palatability
Non-cariogenic

Safety Info

Aspartame – Safety Information

Metabolism & Breakdown Products

  • Breaks down into aspartic acid, phenylalanine, and methanol in very small amounts
  • These components are also naturally present in many foods

Toxicity & Acceptable Intake

  • EFSA ADI: 40 mg/kg body weight/day
  • FDA ADI: 50 mg/kg body weight/day
  • Normal consumption is well below these limits

Special Populations

  • Individuals with phenylketonuria (PKU) must avoid aspartame due to phenylalanine content
  • Products containing aspartame carry phenylalanine warning labels
  • Considered safe for pregnancy and children within ADI limits

Regulatory & Scientific Reviews

  • Approved by FDA, EFSA, WHO, and JECFA
  • Extensive studies show no consistent evidence of carcinogenicity or neurotoxicity at approved levels
  • IARC classified aspartame as possibly carcinogenic (Group 2B) in 2023; JECFA reaffirmed established ADI levels

Common Side Effects

  • Rarely reported
  • Some individuals report headaches or sensitivities without confirmed causal relationship

Storage & Handling Safety

  • Store in a cool, dry place to prevent degradation
  • Avoid exposure to heat and moisture

Why Choose Salius Pharma?

  • GMP-Compliant Quality: Stringent QC to ensure consistent, premium-grade excipients.
  • Regulatory Support: Comprehensive documentation available.
  • Reliable Supply: Global distribution with timely delivery.
  • Technical Expertise: Dedicated formulation support and customer service.
  • Customized Solutions: Flexible packaging and product grades tailored to your needs.
Documents We Provide

FAQs

Aspartame provides a taste closer to sugar with less bitterness compared to some sweeteners, but its heat sensitivity limits certain applications.

Aspartame production has a moderate environmental footprint and is biodegradable, without long-term environmental persistence.

True allergic reactions are extremely rare; reported sensitivities such as headaches have not shown a confirmed causal link.

Yes. COA, MSDS, DMF, Stability Data, COS, Impurity Profile, BA/BE Studies, and WHO-GMP/ISO certificates are available upon request.

No significant drug interactions have been reported.

You can contact export@saliuspharma.com or submit an inquiry through the website Visit On www.saliusapi.com Responses are provided within 24–48 hours.

What You Receive with Every Order

At Salius Pharma, we deliver more than just an excipient — we deliver confidence, compliance, and quality. Every shipment is thoughtfully prepared to meet international regulatory standards and your exact specifications.

What’s Included:

✔ Premium Product:
✔ Custom Packaging Options:

Place an Order or Request a Quote from Salius Pharma

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