Phenylephrine HCl SR Pellets are multiparticulate pharmaceutical pellets containing Phenylephrine Hydrochloride and designed for sustained-release formulation development. The SR pellet format can provide a platform for incorporating a controlled release profile into suitable oral dosage forms.
Phenylephrine Hydrochloride has the molecular formula C₉H₁₃NO₂·HCl, molecular weight 203.67 g/mol, and CAS Number 61-76-7. The current USP-NF monograph specifies Phenylephrine Hydrochloride at 98.0%–102.0%, calculated on the dried basis.
Commercial pharmaceutical-pellet listings specifically identify Phenylephrine Hydrochloride SR Pellets and report a 10% w/w commercial presentation. This is a market reference and should not be entered as the SDP product strength unless confirmed by SDP's own specification.
Phenylephrine HCl SR Pellets can be used for:
SR pellets can be manufactured using suitable pelletization, layering and functional-coating technologies. The final release profile depends on factors such as active-ingredient loading, pellet size, coating composition, coating weight gain and process parameters.
For this reason, assay, pellet size, moisture, coating weight gain and dissolution/release limits should be taken from the validated SDP product specification rather than inferred from the Phenylephrine HCl API monograph.
Phenylephrine HCl SR Pellets may be evaluated for:
The USP API monograph specifies 98.0%–102.0% assay on the dried basis. It should not automatically be used as the finished-pellet assay limit.
| 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 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |