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Product Overview

Product Overview
White Soft Paraffin is a highly refined, semi-solid mixture of hydrocarbons obtained from petroleum. It is widely used as a pharmaceutical excipient due to its excellent emollient, occlusive, and protective properties. White Soft Paraffin is chemically inert, non-irritant, and highly stable, making it ideal for topical, dermatological, and cosmetic formulations.

Product Type: Pharmaceutical Excipient

Chemical Name White Soft Paraffin; Petrolatum; White Petroleum Jelly
CAS Number 8009-03-8
Molecular Weight Approximately 350 – 550 g/mol
Application Role Emollient, Ointment base, Occlusive agent, Skin protectant
Regulatory Compliance IP / BP / USP / Ph.Eur
Manufacturing Suitability ointment, cream, gel, and emulsion manufacturing, base for dermatological, ophthalmic, and veterinary formulations
Storage Conditions Store in a well-closed container in a cool, dry place, protected from heat and light
Certifications GMP, ISO 9001, WHO-GMP
Availability Available in pharmaceutical-grade White Soft Paraffin, supplied in multiple grades and pack sizes as per customer and regulatory requirements
HS Code 2712.10

Excipient Technical Profile

Appearance White to almost white, translucent, smooth semi-solid mass
Density (at 25°C) Approximately 0.82 – 0.86 g/cm³
Solubility Insoluble in water; slightly soluble in chloroform and ether; practically insoluble in ethanol
Acidity / Alkalinity Neutral

Typical Applications

Key Benefits

Chemically Inert and Non-Reactive
High Stability and Long Shelf Life
Excellent Skin Occlusivity and Moisture Retention
Broad Regulatory Acceptance
Non-Irritant and Hypoallergenic
Cost-Effective and Widely Available

Safety Info

⚠️ Safety Information: White Soft Paraffin

Toxicology & Safety Profile

  • Non-toxic and non-sensitizing when used as directed
  • No evidence of mutagenicity or carcinogenicity in pharmaceutical-grade material
  • Safe for pediatric, geriatric, and sensitive skin applications

Handling Precautions

  • Use clean, dedicated equipment to avoid contamination
  • Avoid excessive heating beyond recommended temperatures
  • Follow GMP guidelines during handling and filling

Storage and Stability

  • Store in tightly closed containers
  • Keep in a cool, dry place away from direct sunlight
  • Protect from dust and foreign contamination

Regulatory & Compliance

  • Complies with IP, BP, USP, and Ph.Eur. monographs
  • Listed in FDA Inactive Ingredient Database (IID)
  • Suitable for pharmaceutical, cosmetic, and personal care products
  • Supplied with full regulatory documentation

Why Choose Salius Pharma?

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

FAQs

Yes, highly refined ophthalmic-grade White Soft Paraffin complying with stringent purity and particle limits is suitable for eye ointments.

Generally no, but extreme heat exposure should be avoided during transit to maintain consistency.

COA, MSDS, GMP certificate, ISO certificate, stability data, and regulatory statements.

Yes. Laboratory and pilot-scale samples are available upon request.

Yes. It is widely used in veterinary ointments and topical products.

GMP compliance, consistent quality, full documentation support, reliable logistics, and global regulatory acceptance.

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 White Soft Paraffin or other high-quality pharmaceutical products?
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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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