Paraffin

Paraffin

Paraffin wax is a refined product derived from petroleum, obtained through a series of purification steps to remove non-wax hydrocarbons and impurities. At room temperature, it appears as a solid with a waxy texture, while its melting point can vary depending on molecular weight and composition. A critical feature of paraffin wax for pharmaceutical use is the availability of pharmacopeial-grade material. This grade ensures compliance with strict purity and safety requirements, including tight limits on polycyclic aromatic hydrocarbons (PAHs) and other potentially harmful residues. Such quality standards are essential to guarantee its suitability in medicinal products and safeguard patient safety.

One of the most valuable properties of paraffin wax is its chemical inertness. It shows no significant reactivity with most active pharmaceutical ingredients (APIs) and maintains stability under environmental factors such as light and oxidation. This stability supports the preservation of drug integrity and efficacy throughout the product's shelf life. In addition to its stability, paraffin wax contributes to achieving controlled consistency, smooth texture, and desirable handling properties in a wide range of dosage forms. These attributes make paraffin wax a reliable and versatile excipient in modern pharmaceutical formulation.

Our Products

We offer a range of paraffin products designed to meet the high standards of pharmaceutical applications. Our products are specifically formulated to adhere to the pharmacopoeia standards of multiple regions, ensuring that they are safe and effective for use in medicinal products.

CatalogProduct NameAppearanceMelting PointOthers Pharmacopoeia Standards
PI-PF300Paraffin 300Colorless or white translucent granules52-54 °C
  • USP, EP, ChP
PI-PF301Paraffin 301Colorless or white translucent granules54-56 °C
  • USP, EP, ChP
PI-PF302Paraffin 302Colorless or white translucent granules58-60 °C
  • USP, EP, ChP
PI-PF303Paraffin 303Colorless or white translucent granules60-65 °C
  • USP, EP, ChP
PI-PF304Paraffin 304White slabs / pastilles47-65 °C
  • Acidity, Alkalinity, Readily Carbonizable Substances, Limit of Polycyclic Aromatic Hydrocarbons, Limit of Sulfur Compounds: Complies
  • Residual Solvents Class 3 MEK: NMT 0.5%
  • Residual Solvents Class 2 Toluene: NMT 800 ppm
  • USP/NF

Product Advantages

  • High Purity and Odorless Properties: Our paraffin waxes undergo a meticulous purification process that includes impurity removal, refining, and deodorization. This results in a product that is odorless, tasteless, and has a very low oil content. Key purity indicators, such as easily carbonized substances and polycyclic aromatic hydrocarbons, fully comply with pharmacopeial standards.
  • Excellent Thermal and Oxidative Stability: Our paraffin products exhibit superior thermal stability, oxidation resistance, and light stability. These properties ensure that the formulations remain stable and effective throughout their shelf life, even under varying environmental conditions.
  • Controlled Hardness and Consistency: The melting point of paraffin is directly related to its crystallinity and hardness. The higher the melting point, the greater the crystallinity, which results in a harder product. By precisely controlling the melting point of our paraffin, we can ensure that the hardness of the base material is consistent.

Applications

Ointments and Creams

Paraffin wax is a common stiffening agent in semi-solid preparations. It helps to regulate the consistency and viscosity of ointments and creams, providing the desired texture and spreadability. By using paraffin wax with a specific melting point, formulators can precisely control the final product's hardness.

Suppositories

In suppositories, paraffin wax can be used as a base or a co-base. It helps to ensure that the suppository remains solid at room temperature but melts or softens at body temperature, allowing for the controlled release of the active drug.

Transdermal Patches

Paraffin wax can be incorporated into the matrix of transdermal patches to help control the release rate of the drug. Its inert nature ensures that it does not interfere with the absorption of the active ingredient through the skin.

Tablet Coatings

Paraffin wax can be used as a component in tablet coatings for polishing and to provide a smooth, glossy finish. This improves the aesthetic appeal of the tablet and can also provide a protective layer, helping to mask taste and protect the active ingredient from moisture and light.

Our range of paraffin wax products provides formulators with the tools they need to create high-quality, stable, and effective pharmaceutical products. By offering excipients that meet the highest standards of purity and consistency, we contribute to the safety and efficacy of modern medicines.

Please kindly note that our services are for research use only.

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