Pharmaceutical-Grade Immediate Release Pellets for Oral Dosage Forms
Ambroxol Hydrochloride IR Pellets are pharmaceutical-grade immediate-release multiparticulate pellets containing Ambroxol Hydrochloride, designed for oral dosage-form applications. These pellets provide a convenient formulation platform for pharmaceutical capsule filling and other suitable multiparticulate oral formulations requiring rapid release of the active ingredient.
Ambroxol Hydrochloride is identified by CAS Number 23828-92-4, with molecular formula C₁₃H₁₈Br₂N₂O·HCl and molecular weight approximately 414.6 g/mol. The Indian Pharmacopoeia identifies Ambroxol Hydrochloride as a white or yellowish crystalline powder and specifies an API assay of 99.0%–101.0% on the dried basis. These API specifications should not automatically be treated as the specification of finished IR pellets.
Commercial pharmaceutical pellet manufacturers list Ambroxol Hydrochloride pellets for oral formulation applications. Pel Pharma specifically lists Ambroxol Hydrochloride IR Pellets at 60% strength, while other Indian manufacturers report different Ambroxol Hydrochloride pellet strengths, demonstrating that finished-pellet loading is formulation-specific.
Ambroxol Hydrochloride IR Pellets can be supplied in suitable pharmaceutical packaging for formulation development and bulk manufacturing applications. Packaging configuration, active-ingredient loading, pellet characteristics, dissolution requirements, quantity and storage conditions should be confirmed according to the applicable product specification and customer requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.0%–101.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 4.5–6.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |