COX-2 Preferential NSAID with Superior GI Tolerability for Pain Management
| 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% |
Aceclofenac API (CAS 89796-99-6) is an Active Pharmaceutical Ingredient used in the formulation of prescription and/or over-the-counter pharmaceutical products. Swapnroop Drugs and Pharmaceuticals manufactures and supplies Aceclofenac API with pharmacopeial compliance (IP/BP/EP/USP as applicable) from our WHO-GMP certified facility in Aurangabad (MIDC Shendra), Maharashtra — one of India's premier pharmaceutical manufacturing zones with robust regulatory infrastructure.
Pharmaceutical formulation companies sourcing Aceclofenac API require consistent polymorphic or salt form characterisation, batch-to-batch HPLC purity ≥98% (or per specific pharmacopeial monograph), validated residual solvent control per ICH Q3C, and full impurity profiling against pharmacopeial limits. Our quality control laboratory performs complete pharmacopeial testing with USP/EP/IP validated analytical methods before every batch release.
Swapnroop's Aceclofenac API supply is backed by WHO-GMP certified manufacturing, a qualified vendor documentation package (CoA, MSDS, Certificate of Origin, stability data), and dedicated technical support for domestic formulation companies and international export customers. We maintain inventory for rapid order fulfilment across 25+ countries served from our Aurangabad facility.
Aceclofenac API is supplied in double-polyethylene-lined HDPE drums or fiber drums (25 kg net) with desiccant and nitrogen head-space. Smaller quantities (1 kg, 5 kg) in sealed HDPE jars for R&D programs. All packaging labelled with batch, grade, and pharmacopeial standard.
Get Bulk QuoteThe CAS number for Aceclofenac is 89796-99-6. It is a phenylacetic acid derivative COX-2 preferential NSAID.
Aceclofenac is a prodrug that is partially metabolised to Diclofenac in vivo. It shows preferential COX-2 inhibition and better GI tolerability than conventional Diclofenac, making it preferred in osteoarthritis and rheumatoid arthritis treatment in many Asian and European markets.
Per IP and BP specifications, Diclofenac impurity in Aceclofenac API should be controlled to ≤0.1%. Swapnroop provides impurity profile certificates with every commercial batch.
Minimum order is 25 kg for commercial supply. We offer competitive pricing for volumes above 100 kg, 500 kg, and full drum quantities for large Indian formulation manufacturers.
Yes. We provide dissolution profile data (IP specification: Q ≥75% in 45 minutes in phosphate buffer pH 7.4) with batch documentation to support formulation development and ANDA/dossier submissions.
Swapnroop Drugs and Pharmaceuticals is a trusted Aceclofenac API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Aceclofenac API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Aceclofenac API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Aceclofenac API pricing, samples, and sourcing support.