Sodium Starch Glycolate-Based Pellets are pharmaceutical-grade excipient pellets developed using sodium starch glycolate as a key functional component of the pellet system. Sodium starch glycolate is the sodium salt of a carboxymethyl ether of starch and is available in different compendial types, including Type A and Type B, with defined sodium-content and pH ranges. It is a highly hygroscopic, water-swellable starch derivative used primarily for its rapid swelling characteristics in pharmaceutical formulations.
In pelletized form, sodium starch glycolate can provide a convenient multiparticulate excipient system with controlled physical characteristics. The finished pellet properties depend on the composition, pelletization process, particle-size distribution, moisture level and any additional formulation components used during manufacturing.
Sodium Starch Glycolate-Based Pellets can be considered for pharmaceutical formulation development, multiparticulate systems, capsule-filling applications and other oral solid formulation processes where a sodium starch glycolate-based pellet system is required.
Sodium starch glycolate has CAS Number 9063-38-1 and is chemically described as starch carboxymethyl ether, sodium salt. The material is a polymeric starch derivative, so it does not have one fixed molecular weight or a conventional single molecular formula applicable to all grades.
Compendial sodium starch glycolate distinguishes between Type A and Type B. Type A contains 2.8–4.2% sodium, while Type B contains 2.0–3.4% sodium. The corresponding pH ranges are 5.5–7.5 for Type A and 3.0–5.0 for Type B.
The pelletized product should therefore identify the applicable sodium starch glycolate type where relevant.
Sodium Starch Glycolate-Based Pellets can be considered for:
The finished pellet can be evaluated for:
The exact finished-pellet limits should be established according to the actual product specification and manufacturing process.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 10.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 5.5–7.5 |
| Water Content | NMT 10.0% |