+91 84258 80640 export@saliuspharma.com

Product Overview

Potato starch is a natural polysaccharide derived from the tubers of solanum tuberosum.It is widely used in pharmaceutical industry as an excipient which is an inactive substance formulated alongside the API to aid in the manufacturing process and improve the performance of the final dosage form.

Product Type: Pharmaceutical Excipient

Chemical Name Starch (Potato-derived)
Chemical Formula (C₆H₁₀O₅)ₙ
CAS Number 9005-25-8
Molecular Weight ~162.14 g/mol
Application Role Binder, Disintegrant, Filler/Diluent, Glidant
Regulatory Compliance FDA
Manufacturing Suitability Suitable for direct compression, wet granulation, and capsule filling, Compatible with a wide range of APIs, Non-reactive and stable under standard conditions
Storage Conditions Store in a cool, dry, well-ventilated area, Protect from moisture, heat, and direct sunlight
Certifications FDA GRAS, GMP (depending on manufacturer)
Availability Widely available globally, Supplied as a white to off-white, odorless powder
HS Code 1108.13

Excipient Technical Profile

Appearance White to off-white Fine powder
Bulk Density 0.50 – 0.65 g/cm³
Solubility Insoluble In Cold Water, Insoluble In Organic Solvents

Typical Applications

Key Benefits

Excellent Disintegration Properties
Inert and Chemically Stable
Natural and Biocompatible
Cost-Effective and Readily Available
Multifunctional Excipient
Regulatory Acceptance

Safety Info

⚠️ Starch (Potato)– Safety Information

Toxicological Profile

  • Acute Toxicity: Non-toxic; no adverse effects reported at typical oral doses.
  • Chronic Toxicity: No known chronic toxicity when used within recommended limits.

Sensitization and Allergic Reactions

  • Non-irritating under normal handling conditions.
  • Inhalation of dust may cause mild respiratory discomfort in sensitive individuals.

Environmental Impact

  • Biodegradability: Fully biodegradable
  • Environmental Impact: Minimal; derived from renewable sources
  • Disposal: Safe for disposal as non-hazardous waste in accordance with local regulations.

Handling Precautions

  • Dust Hazard: Fine powder may pose a dust explosion risk in large quantities; use proper dust control measures in industrial settings
  • PPE: Use appropriate dust masks, gloves, and eye protection during handling.

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

Yes, pharmaceutical-grade potato starch is non-toxic, biocompatible, and recognized as Generally Recognized as Safe (GRAS) by the FDA. It complies with pharmacopeial standards like USP and Ph. Eur.

Potato starch swells rapidly when it absorbs water, causing tablets to break apart quickly in the gastrointestinal tract, which helps release the active drug effectively.

We provide certificates including Certificate of Analysis (CoA), Certificate of Origin (CoO), GMP compliance certificates, Halal/Kosher certifications (if requested), and Safety Data Sheets (SDS) to comply with international regulatory requirements.

Potato starch is typically packed in 25 kg or 50 kg multi-layer kraft paper bags with inner polyethylene liners to ensure moisture protection. Customized packaging is available upon request.

Absolutely. We cater to both small and large bulk orders with flexible shipment schedules based on client requirements.

You can request a product catalogue or custom quotation by contacting us at export@saliuspharma.com or through the inquiry form submitted on our website. Our export team responds to all inquiries 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

Looking to source Starch (Potato) or other high-quality pharmaceutical products?
We’re here to help.
Whether you need Active Pharmaceutical Ingredients (APIs), excipients, or regulatory support, our team is ready to provide reliable, compliant, and cost-effective solutions tailored to your market needs.

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Any patented products are excluded from our offerings in regions where such patents are currently in force.

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