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Product Overview

Crospovidone has excellent disintegrant properties and is widely used in pharmaceutical formulations. It is used in direct compression formulations and wet granulation processes due to its high swelling capacity and inert nature. Due to its unique physical and chemical properties, it contributes to improving the efficacy and reliability of oral drug delivery systems.

Product Type: Pharmaceutical Excipient

Chemical Name Cross-linked Polyvinylpyrrolidone
Chemical Formula (C6H9NO)n
CAS Number 25249-54-1
Molecular Weight Approximately 25,000 – 60,000 Da
Application Role Superdisintegrant in tablets and capsules to enhance disintegration and dissolution
Regulatory Compliance BP / USP / EP
Manufacturing Suitability Suitable for direct compression and wet granulation processes due to high swelling capacity and non-gelling behavior
Storage Conditions Store in a cool, dry place away from moisture and direct sunlight to maintain stability
Certifications GMP (depending on manufacturer)
Availability Widely available from multiple pharmaceutical excipient suppliers globally
HS Code 39139090

Excipient Technical Profile

Appearance White to off-white free-flowing powder
Bulk Density 0.3 – 0.5 g/cm³
Solubility Insoluble in water and organic solvents

Typical Applications

Key Benefits

Rapid disintegration
High swelling capacity
Improved bioavailability
Good flow properties
Insoluble and non-gelling
Regulatory acceptance

Safety Info

Crospovidone – Safety Information

Toxicological Profile

  • Non-toxic when used within recommended concentrations (typically 2–5%)
  • Oral LD₅₀ (rat) >100 g/kg indicating very low acute toxicity

Inhalation Risk

  • Excessive dust inhalation should be avoided
  • Use local exhaust ventilation and appropriate PPE when required

Skin and Eye Contact

  • Not known to be a skin or eye irritant
  • Non-sensitizing and suitable for oral administration

Handling Precautions

  • Use standard industrial hygiene practices
  • Wear dust mask, gloves, and safety goggles when handling large quantities
  • Avoid contact with eyes and prolonged skin contact

Environmental Impact

  • Not expected to pose environmental risks under normal usage
  • Dispose of according to local, regional, or national regulations

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

Lead time typically ranges from 2 to 4 weeks depending on order size, destination, and availability. Express air shipments are available upon request.

Yes. Free samples are available upon request along with CoA and technical documentation.

No. It is not a controlled substance and is classified as non-hazardous for international transport.

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

It should be stored and transported in cool, dry conditions, avoiding moisture and direct sunlight.

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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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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