Bisoprolol IR Pellets are pharmaceutical-grade immediate-release multiparticulate pellets containing Bisoprolol Fumarate as the active ingredient. Bisoprolol Fumarate has CAS Number 104344-23-2, molecular formula (C₁₈H₃₁NO₄)₂·C₄H₄O₄, and molecular weight 766.97 g/mol. The current USP specification for Bisoprolol Fumarate is 97.5%–102.0%, calculated on the anhydrous basis.
The immediate-release pellet format is designed to provide rapid release of Bisoprolol after administration. The multiparticulate system can provide flexibility in capsule-filling and oral formulation development, with the final release characteristics determined by the pellet composition, active loading, particle size and excipient system.
Bisoprolol Fumarate is used in immediate-release solid oral formulations, and published pharmaceutical literature describes immediate-release Bisoprolol formulations with dissolution assessment at pH 1.2, 4.5 and 6.8.
Important: I could not verify a reliable universal commercial strength specifically for Bisoprolol IR Pellets. Therefore, an exact pellet loading should not be invented. The SDP strength should be entered from the current SDP product specification or COA.
Bisoprolol IR Pellets are designed for immediate-release oral formulations requiring rapid active-ingredient release.
The multiparticulate pellet format is suitable for incorporation into capsule dosage forms according to the required active loading and formulation specification.
The pellets can be used as a formulation intermediate for development and optimization of oral multiparticulate dosage forms.
Bisoprolol IR Pellets can be incorporated into pharmaceutical manufacturing processes where a controlled pellet size, active loading and immediate-release profile are required.
The pellets can be supplied in bulk according to the approved active loading and finished-product quality specification.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| Water Content | NMT 1.0% |