Rice Starch Pellets are pharmaceutical excipient-based spherical pellets prepared from rice starch obtained from Oryza sativa L. Rice starch is an established pharmaceutical excipient and can be processed into spherical pellet forms for multiparticulate formulation, coating and capsule-filling applications. USP-NF recognizes Rice Starch as an excipient, while pharmacopoeial specifications include identification, pH, iron, oxidizing substances, sulfur dioxide, loss on drying and sulfated ash.
Commercial Rice Starch Pellets are available as spherical, free-flowing pellets. A current commercial pharmaceutical pellet specification reports 0.30–1.50 mm particle size, 0.40–0.60 g/mL bulk density, ≤5.0% moisture, pH 5.0–7.0, ≤0.5% ash and ≥98.0% starch content. These values are useful as a product-specific commercial reference, but should not be represented as SDP's specification unless confirmed by SDP's COA.
Rice Starch Pellets can be considered for:
Rice Starch Pellets can provide a spherical and free-flowing excipient platform. Commercial pellet specifications demonstrate particle sizes around 0.30–1.50 mm, with bulk density and moisture controlled for handling and processing.
The exact pellet size, starch content, moisture, bulk density and friability should be controlled according to the actual SDP grade and COA.
Rice Starch Pellets can be supplied for pharmaceutical formulation and bulk manufacturing requirements. Particle size, starch content, moisture, packaging configuration and finished-product specifications should be confirmed against the applicable product specification and COA.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 95.0% – 105.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Water Content | NMT 0.5% |