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Product Overview

Saccharin Sodium is the sodium salt of saccharin, a high-intensity, non-nutritive artificial sweetener. It is approximately 300–500 times sweeter than sucrose and is widely used in pharmaceutical, food, beverage, and personal care formulations. Due to its excellent stability, cost-effectiveness, and broad regulatory acceptance, Saccharin Sodium is a preferred sweetening agent in solid and liquid dosage forms.

Product Type: Pharmaceutical Excipient

Chemical Name Sodium Saccharin; Saccharin Sodium Salt
CAS Number 128-44-9
Molecular Weight 205.17 g/mol
Application Role High-intensity sweetening agent, taste-masking excipient, non-nutritive sugar substitute
Regulatory Compliance IP / BP / USP / Ph.Eur / FCC
Manufacturing Suitability Tablets (chewable, dispersible, lozenges), syrups, oral solutions, suspensions, powders, sachets, nutraceutical formulations, and oral care products (toothpaste, mouthwash)
Storage Conditions Store in a well-closed container in a cool, dry place, protected from moisture and direct light
Certifications GMP, ISO 9001, WHO-GMP
Availability Available in pharmaceutical, food, and FCC grades; supplied in multiple pack sizes as per customer and regulatory requirements
HS Code 2925.11

Excipient Technical Profile

Appearance White to off-white crystalline powder
Density (at 25°C) Approximately 0.83 – 0.90 g/cm³ (bulk density may vary with grade and particle size)
Solubility Freely soluble in water<br>Slightly soluble in ethanol<br>Practically insoluble in chloroform and ether
Acidity / Alkalinity Neutral to slightly alkaline

Typical Applications

Key Benefits

High Sweetening Power at Low Concentrations
Broad Global Regulatory Acceptance
Excellent Thermal and Chemical Stability
Cost-Effective Compared to Other Sweeteners
Non-Caloric and Non-Cariogenic
Cost-Effective and Widely Available

Safety Info

⚠️ Safety Information: PVP K 30 (Polyvinylpyrrolidone)

Toxicology & Safety Profile

  • Non-carcinogenic when used within regulatory limits
  • Safe for diabetic and calorie-controlled formulations
  • Extensive history of use in pharmaceuticals and foods

Handling Precautions

  • Avoid inhalation of fine powder
  • Use appropriate PPE during handling
  • Follow GMP and hygiene practices

Storage & Stability

  • Store in well-closed containers
  • Keep in a cool, dry place away from moisture
  • Stable under normal storage conditions

Why Choose Salius Pharma?

  • GMP-Compliant Quality Systems
  • Consistent, High-Purity Pharmaceutical Grades
  • Complete Regulatory Documentation Support
  • Reliable Global Supply Chain
  • Custom Packaging and Grade Options
Documents We Provide

FAQs

Yes. Technical and regulatory assistance is provided to support local importer registrations.

Identification, assay, solubility, pH, loss on drying, impurities, and microbial limits as per pharmacopeial standards.

Strict GMP controls, validated processes, and in-process quality monitoring ensure batch-to-batch consistency.

Pharmacopeial compliance, strong documentation support, export-ready packaging, regulatory expertise, and a dependable global supply chain.

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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