Sodium Formaldehyde Sulfoxylate

Functional Category

Antioxidant.

Applications in Pharmaceutical Formulation

Sodium formaldehyde sulfoxylate is a water-soluble antioxidant and is generally used as the dihydrate. It is used in the formulation of injection products at a level of up to 0.1% w/v in the final preparation administered to the patient.

Description

When freshly prepared, sodium formaldehyde sulfoxylate occurs as white, odorless crystals, which quickly develop a characteristic garlic odor on standing.

Stability and Storage Conditions

Store in well-closed, light-resistant containers at controlled room temperature (15–30 C).

Incompatibilities

Sodium formaldehyde sulfoxylate is incompatible with strong oxidizing agents; it is decomposed by dilute acid.

Safety

The toxicological properties of sodium formaldehyde sulfoxylate have not been fully investigated. However, it is used in the formulation of injection products at a level to 0.1% w/v in the final preparation administered to the patient. Sodium formaldehyde sulfoxylate is moderately toxic by ingestion, and when heated to decomposition it emits toxic fumes of sulfur dioxide and sodium oxide.(1) LD50 (mouse, oral): 4 g/kg(1,2) LD50 (rat, IP): >2 g/kg(2) LD50 (rat, oral): >2 g/kg(2)

External Links
Sodium Formaldehyde Sulfoxylate