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Sodium Sulfite
Pharmaceutical Chemistry

Sodium Sulfite

Formula: Na₂SO₃ GOST/CAS: CAS 7757-83-7

Sodium Sulfite (Pharma Grade) is a high-purity inorganic compound occurring as an odorless (or almost odorless), white crystalline powder or granules that are readily soluble in water. Within the pharmaceutical industry, this product plays a critical role as a highly effective antioxidant, preservative, and stabilizer. It prevents the oxidative degradation of Active Pharmaceutical Ingredients (APIs), ensuring the stability, safety, and regulatory shelf-life of finished dosage forms.

Applications

Production of Injectables and Liquid Dosage Forms: Utilized as an antioxidant in solutions for injection, eye drops, nasal drops, and syrups. It protects labile drug substances from oxidation caused by atmospheric oxygen.
Production of Semi-Solid Dosage Forms (Ointments, Creams, Gels): Used to prevent changes in color, consistency, and therapeutic activity of ointments and liniments that contain easily oxidizable components.
Pharmaceutical Synthesis and Laboratory Analysis: Serves as a reducing agent and reagent in organic synthesis processes for manufacturing drug substances, as well as in analytical quality control.
Cosmeceuticals and Personal Care (Premium/Pharma): Incorporated into formulations of specialized therapeutic shampoos, creams, and toothpastes to stabilize active vitamin complexes and botanical extracts.

Key Advantages

High Purity Level (Pharma Grade): Complies with the stringent requirements of leading pharmacopoeias (EP, USP, BP), guaranteeing minimal content of heavy metals and foreign impurities.
Reliable Antioxidant Protection: Effectively binds dissolved oxygen, blocking free-radical processes and preventing the decomposition of sensitive pharmaceutical active ingredients.
Color and Organoleptic Stabilization: Prevents darkening, yellowing, and odor alteration of finished solutions and emulsions during storage.
Excellent Solubility: Dissolves quickly and completely in aqueous media, simplifying the technological workflow of preparing liquid medicines.

Storage & Transportation

  • Store in dry, clean, cool warehouse premises in tightly closed original factory packaging, away from heat sources and direct sunlight.
  • Critical Note: Avoid exposure to moisture and air during storage, as the product gradually oxidizes to sodium sulfate in damp environments.
  • Avoid co-storage and contact with strong acids and oxidizing agents. Reaction with acids releases toxic sulfur dioxide gas
  • Recommended storage temperature range: +5°C to +25°C.
  • Transportation is permitted by all types of covered transport in strict accordance with freight regulations.
  • Shelf Life: 1–2 years from the date of manufacture (depending on the airtightness of the packaging).

Technical Specifications

Appearance White crystalline powder or granules
Assay 98.0% – 100.5%
Chlorides max. 0.01%
Heavy Metals max. 10 ppm (0.001%)
Iron max. 10 ppm (0.001%)
pH (5% aqueous solution) 8.5 – 10.5
Solubility Freely soluble in water, practically insoluble in ethanol

Supply info

  • Polyethylene bags with an airtight inner liner at 25 kg net.
  • Big-bags (FIBC) at 500 kg / 1000 kg for large-scale industrial manufacturing.
  • Custom packaging options are available upon agreement with the customer.

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Merit Chemicals