Pharmaceutical-Grade Direct Compression Granules for Solid 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% |
Diclofenac Sodium DC Granules are pharmaceutical-grade direct compression granules engineered for high-throughput tablet manufacturing without wet granulation. These granules provide excellent flowability, compressibility, and content uniformity critical for regulated solid dosage form production.
Formulators sourcing Diclofenac Sodium DC Granules evaluate particle size distribution (D50, D90), bulk/tapped density ratio, angle of repose, and moisture content for press performance. Batch-to-batch consistency in compressibility index (Carr's Index <20%) ensures reliable tableting across different press configurations.
Swapnroop Drugs and Pharmaceuticals manufactures Diclofenac Sodium DC Granules from our WHO-GMP certified Aurangabad facility. We supply controlled particle size batches with full granule characterisation data, CoA, and regulatory documentation support for ANDA/CTD dossier submissions.
Diclofenac Sodium DC Granules are supplied in double-layer HDPE bags within fibre drums (10 kg, 25 kg) with desiccant sachets to maintain flowability and prevent moisture uptake during storage and transit.
Get Bulk QuoteDiclofenac Sodium DC Granules are available with D50 in the 100–300 µm range, optimised for direct compression. Customised particle size distributions can be discussed for specific press and formulation requirements.
We provide full CoA, MSDS, particle size analysis report, bulk/tapped density data, moisture content certificate, and regulatory dossier support for ANDA/CTD submissions.
Minimum order is 5 kg for development batches and 25 kg for commercial supply. Standard lead time is 2–3 weeks from our Aurangabad, Maharashtra facility.
Yes. All granule batches are manufactured at our WHO-GMP certified facility in MIDC Shendra, Aurangabad, with full traceability and quality documentation for regulated market submissions.
Swapnroop Drugs and Pharmaceuticals is a trusted Diclofenac Sodium DC Granules manufacturer and bulk supplier in Aurangabad, Maharashtra, supplying pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Diclofenac Sodium DC Granules with full characterisation data, competitive pricing, and complete documentation for solid dosage form development and commercial production.
As a Diclofenac Sodium DC Granules supplier from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, CoA, particle size analysis, and regulatory filing assistance for USFDA and EU submissions. Contact us for pricing, samples, and technical data.
The CAS number for Diclofenac Sodium DC Granules DC API is available on request. Please verify the exact salt or hydrate form you require as different forms carry distinct CAS numbers.
Diclofenac Sodium DC Granules DC API is available in IP / BP / EP / USP pharmacopeial grades, manufactured under WHO-GMP certified conditions with full impurity profiling per ICH Q3A and pharmacopeial identification testing (IR, HPLC).
Minimum order is 1 kg for R&D sampling and 25 kg for commercial bulk supply. Standard lead time is 2-4 weeks from our Aurangabad, Maharashtra facility. Expedited supply available for urgent requirements.
Yes, Swapnroop provides full DMF-grade documentation for Diclofenac Sodium DC Granules DC API including CoA, MSDS, impurity report, stability data, and complete regulatory dossier support for USFDA, EMA, and CDSCO submissions.