Starch-Containing Pellets are pharmaceutical excipient-based multiparticulate pellets in which starch is incorporated as one component of the pellet formulation along with other excipients or formulation materials. Unlike a pure Starch Pellets product, the term “starch-containing” indicates that starch is a component of the finished pellet rather than necessarily being the only or predominant material.
Starch is a naturally derived carbohydrate polymer represented by CAS 9005-25-8 and the general polymeric formula (C₆H₁₀O₅)n. Its molecular weight is variable because starch consists of polymeric chains with different degrees of polymerization.
The properties of starch-containing pellets depend on the type and percentage of starch, other formulation components, pelletization process, particle-size distribution and moisture level. USP emphasizes that excipient properties and their effects can vary according to the formulation, manufacturing process, supplier and batch, so finished-product specifications should be established for the specific formulation.
Commercial starch pellet references demonstrate that spherical starch-based pellets can be produced with controlled physical characteristics. However, specifications for a starch-containing pellet should not be copied from a pure starch pellet because the presence of other components can change the final assay, moisture, density and physical properties.
Starch-Containing Pellets can be considered for:
The final characteristics of Starch-Containing Pellets depend on the starch source, starch concentration, additional excipients, pelletization process and intended formulation application.
For example, a commercial starch pellet reference uses controlled parameters such as particle size, moisture, ash, pH and density. These parameters demonstrate the types of controls that may be relevant to a finished pellet, but they should not be treated as universal specifications for starch-containing pellets.
For the SDP CMS, the actual starch loading and finished-product specifications should therefore be entered from the applicable SDP product specification or COA.
Starch-Containing Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Starch loading, particle size, moisture, density, packaging configuration and other finished-product parameters 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) | 97.0% – 103.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |