Pharmaceutical-Grade Nitrofurantoin IR Pellets for Immediate-Release Oral Formulations
Nitrofurantoin IR Pellets are pharmaceutical multiparticulate formulations designed for immediate-release oral dosage applications. Nitrofurantoin has the CAS Number 67-20-9, molecular formula C₈H₆N₄O₅, and molecular weight 238.16 g/mol for the anhydrous form. Nitrofurantoin monohydrate is identified by CAS 17140-81-7.
Swapnroop's product portfolio lists Nitrofurantoin IR Pellets in 35% and 50% strengths, providing formulation flexibility for pharmaceutical manufacturers developing immediate-release multiparticulate formulations.
The IR pellet format is designed to provide rapid release of the active ingredient from the multiparticulate system. Pellet formulation characteristics, coating or functional excipient systems, particle-size distribution and release performance are controlled according to the applicable finished-product specification.
Nitrofurantoin is available in an anhydrous form and as a monohydrate. The USP monograph identifies anhydrous Nitrofurantoin as C₈H₆N₄O₅, 238.16, while the monohydrate has a molecular weight of 256.18. USP specifies Nitrofurantoin at 98.0–102.0%, calculated on the anhydrous basis, for the API.
For finished Nitrofurantoin IR Pellets, the API specification should not be confused with the finished pellet assay. The finished product is evaluated according to its specified active loading and applicable quality parameters.
Both strengths are listed in the SDP pellet product catalogue.
Nitrofurantoin IR Pellets can be used for:
Nitrofurantoin IR Pellets can be supplied in suitable bulk packaging according to formulation and commercial requirements. Strength, batch quantity, packaging configuration and applicable documentation can be specified according to customer requirements.
| 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% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |