Pharmaceutical-Grade Enteric Coated Pellets for Oral Dosage Forms
| 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 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Duloxetine HCl EC Pellets are pharmaceutical-grade enteric coated pellets designed for capsule filling, minitablet compression, and multiparticulate oral dosage form manufacturing. These pellets provide predictable drug release profiles critical for bioequivalence and patient compliance.
Formulators sourcing Duloxetine HCl EC Pellets evaluate pellet size distribution (500–1400 µm), drug content uniformity (RSD <2%), dissolution profile correlation (f2 >50 vs reference), and coating thickness consistency. Robust membrane integrity testing ensures reproducible in-vivo release performance.
Swapnroop Drugs and Pharmaceuticals manufactures Duloxetine HCl EC Pellets from our WHO-GMP certified Aurangabad facility using Wurster fluid-bed coating technology. We supply dissolution-profiled batches with full regulatory documentation for ANDA/CTD dossier submissions.
Duloxetine HCl EC Pellets are supplied in double-layer LDPE bags within amber HDPE containers (1 kg, 5 kg, 10 kg) with nitrogen purge and desiccant sachets to protect the coating integrity and drug potency during storage and international transit.
Get Bulk QuoteDuloxetine HCl EC Pellets are designed to provide a enteric coated profile with dissolution tested in USP Apparatus 1/2 at multiple pH media. Actual dissolution profile data and f2 comparison data available on request.
Full CoA, dissolution profile report, MSDS, drug content uniformity data, coating weight data, and regulatory support for ANDA/CTD dossier submissions including DMF referencing.
Minimum order is 1 kg for R&D sampling and 5 kg for development batches. Standard commercial lead time is 3–4 weeks from our Aurangabad, Maharashtra facility.
Yes. All pellet batches are manufactured at our WHO-GMP certified facility in MIDC Shendra, Aurangabad, with validated Wurster coating process and full traceability documentation.
Swapnroop Drugs and Pharmaceuticals is a trusted Duloxetine HCl EC Pellets manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Duloxetine HCl EC Pellets with full dissolution profiling, competitive pricing, and complete documentation for capsule fill and multiparticulate development programs.
As a Duloxetine HCl EC Pellets supplier from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, CoA, dissolution data, and regulatory filing assistance. Contact us for pricing, samples, and technical data.