Metronidazole SR Pellets are pharmaceutical-grade multiparticulate pellets containing Metronidazole and designed for sustained-release oral dosage-form development. The pellet format provides a flexible platform for capsule filling and other multiparticulate pharmaceutical formulations.
Metronidazole has CAS Number 443-48-1, molecular formula C₆H₉N₃O₃, and molecular weight 171.15 g/mol. The USP-NF monograph defines Metronidazole at 99.0%–101.0%, calculated on the dried basis.
Commercial pharmaceutical-pellet listings specifically include Metronidazole SR Pellets, with one Indian manufacturer listing a 60% presentation. This is a commercial reference and should not be treated as the SDP finished-pellet strength unless confirmed by the applicable SDP specification.
Metronidazole Sustained-Release Pellets are designed around a multiparticulate formulation approach in which the release profile can be controlled through the pellet composition and, where applicable, a functional coating or release-controlling matrix.
The final release characteristics depend on factors such as active-ingredient loading, pellet size, excipient system, polymer/coating characteristics, coating weight gain and manufacturing conditions.
For this reason, the finished Metronidazole SR Pellets specification should be established independently from the Metronidazole API specification.
Metronidazole SR Pellets can be considered for:
Metronidazole SR Pellets may be manufactured using suitable pelletization, layering and functional-coating technologies.
Important product parameters may include:
These characteristics should be controlled according to the approved finished-product specification.
Metronidazole SR Pellets may be evaluated for:
The USP-NF Metronidazole monograph specifies 99.0%–101.0% assay on the dried basis for the API. This is an API specification and should not automatically be used as the finished-pellet assay range.
Metronidazole SR Pellets from Swapnroop are positioned as pharmaceutical-grade multiparticulate pellets for sustained-release formulation development and capsule-filling applications.
Metronidazole SR Pellets can be supplied in suitable pharmaceutical bulk packaging according to the applicable product specification. Active loading, pellet size, release characteristics, packaging configuration and analytical requirements should be confirmed before commercial supply.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 95.0% – 105.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 1.0% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 2.0% |