Clopidogrel Bisulphate IR Pellets are pharmaceutical-grade immediate-release multiparticulate pellets containing Clopidogrel Bisulphate as the active ingredient. Clopidogrel Bisulphate has CAS Number 120202-66-6, molecular formula C₁₆H₁₆ClNO₂S·H₂SO₄, and molecular weight 419.90 g/mol. The current USP monograph specifies 97.0–101.5% Clopidogrel Bisulphate, calculated on the dried basis.
The immediate-release pellet format provides a multiparticulate platform for oral formulation development. Active loading, pellet size, moisture, physical characteristics and dissolution are controlled according to the finished-product specification. The format can be used for capsule-filling and other multiparticulate formulation applications.
A commercial pharmaceutical pellet portfolio specifically lists Clopidogrel Bisulphate IR Pellets at 50% w/w strength. For the SDP website, this 50% strength should be published only if it corresponds to the current SDP specification/COA.
Clopidogrel Bisulphate IR Pellets are designed for immediate-release multiparticulate oral formulations.
The pellet format is suitable for incorporation into capsule dosage forms according to the selected active loading and formulation specification.
Individual pellets provide a flexible intermediate for development of oral multiparticulate formulations.
The pellets can be used as a formulation intermediate where controlled active loading, pellet characteristics and immediate-release performance are required.
Clopidogrel Bisulphate IR Pellets can be supplied in bulk according to the approved finished-product specification.
| 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% |
| Water Content | NMT 0.5% |