Sodium Starch Glycolate Pellets are pharmaceutical excipient-based multiparticulate pellets formulated using sodium starch glycolate as the principal excipient component. Sodium starch glycolate is the sodium salt of a cross-linked, partly O-carboxymethylated starch and is recognized as a pharmaceutical excipient. The International Pharmacopoeia identifies it as a disintegrant and describes it as a hygroscopic material that forms a translucent suspension in water.
Sodium Starch Glycolate is identified by CAS 9063-38-1. It is available in different pharmacopoeial types, with the sodium content differing by type. The harmonized pharmacopoeial specification gives 2.8–4.2% sodium for Type A and 2.0–3.4% sodium for Type B, calculated on the specified dried, ethanol-washed basis.
Pelletization converts the excipient into a multiparticulate format suitable for formulation development, capsule-filling systems and further processing. The finished-pellet loading, particle size, moisture, density, mechanical properties and any coating parameters are product-specific and should be confirmed against the applicable SDP specification.
Sodium Starch Glycolate Pellets can be considered for:
The characteristics of the finished pellets depend on the sodium starch glycolate type, raw-material grade, pellet composition, processing method and target particle size.
The International Pharmacopoeia describes sodium starch glycolate as very hygroscopic and practically insoluble in dichloromethane, while producing a translucent suspension in water.
For the underlying excipient, the harmonized USP/Ph. Eur./JP specifications include controls for pH, loss on drying, iron, sodium chloride, sodium glycolate and sodium content.
Sodium Starch Glycolate Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Pellet size, sodium starch glycolate loading, moisture, density, packaging configuration and finished-product acceptance criteria should be confirmed against the applicable SDP product specification and COA.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Water Content | NMT 0.5% |