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Pharmaceutical Chemistry
Sodium Starch Glycolate
Formula:
(C6H9O5CH2COONa)n
GOST/CAS:
CAS 9063-38-1
Sodium Starch Glycolate (superdisintegrant, the sodium salt of a carboxymethyl ether of starch) is a highly efficient pharmaceutical-grade excipient. It appears as a fine, white or almost white, free-flowing powder that is practically insoluble in water and organic solvents. Due to its unique ability to rapidly swell (increasing in volume by up to 200–300% upon contact with moisture), this product serves as an indispensable disintegrating agent (disintegrant) in the manufacture of solid dosage forms (tablets and capsules), ensuring their fast and uniform dissolution in the gastrointestinal tract.
Applications
Tablet Manufacturing: Used as a superdisintegrant in direct compression, as well as wet and dry granulation processes. It ensures instantaneous tablet breakup, significantly enhancing the bioavailability of Active Pharmaceutical Ingredients (APIs).
Capsule Formulations: Applied as a filler and disintegrant during the filling of hard gelatin capsules, preventing the powder mass from clumping and promoting rapid drug release.
Effervescent and Soluble Forms: Incorporated into fast-dissolving granules and powders to accelerate the hydration process and ensure even distribution of active substances throughout the liquid.
Specialized Medical Devices: Can be utilized as a hydrophilic agent in certain types of wound dressings and absorbent medical materials.
Key Advantages
High Disintegration Speed: Features a powerful capillary effect and immense swelling capacity. Tablets disintegrate within seconds, guaranteeing rapid API release.
Processing Versatility: Equally effective in both direct compression and wet granulation (it can be added intragranularly, extragranularly, or split between both phases).
Stability Under Compression: Disintegration efficiency remains unimpaired even under high compression forces on tablet presses, allowing the production of robust tablets with excellent disintegration profiles.
Inertness and Safety: Fully compatible with most active components, non-toxic, and hypoallergenic. It strictly complies with international pharmacopeia standards (USP/NF, Ph. Eur., BP).
Storage & Transportation
- Store in dry, clean, and well-ventilated warehouse premises in the tightly closed original packaging, away from moisture and heat sources.
- Recommended temperature range: +5°C to +30°C. The product is highly hygroscopic; do not allow packaging damage to avoid lump formation.
- Avoid exposure to direct sunlight. Storage on pallets is recommended to exclude direct contact with the floor.
- Transportation is permitted by all types of covered transport, provided that container tightness is maintained. The material is not classified as hazardous cargo (ADR classification is not applicable).
- Shelf Life: 3 years from the date of manufacture.
Technical Specifications
Appearance
Fine, white or almost white, odorless, free-flowing powder
Molecular Weight
High molecular weight polymer (depends on the degree of polymerization)
Assay (Sodium content)
≥ 98.0%
Bulk Density
0.55 – 0.85 {g/cm}3
pH (4% aqueous suspension)
5.5 – 7.5 or 3.0 – 5.0 (depending on the grade/Type A or Type B)
Swelling Factor
Volume increases by at least 2.5–3 times upon contact with water
Loss on Drying
≤ 10,0%
Supply info
- Pharmaceutical-grade multi-layer kraft paper bags with an inner polyethylene liner containing 25 kg (optimal for powder forms).
- Available on shrink-wrapped pallets for large wholesale shipments.