Swapnroop Drugs & Pharmaceuticals is a pharmaceutical Tolmetin Sodium API manufacturer and supplier in India, providing pharmaceutical-grade active pharmaceutical ingredients for qualified pharmaceutical manufacturers, formulation companies, research organizations, and bulk procurement requirements.
Tolmetin Sodium is the sodium salt of Tolmetin, a non-steroidal anti-inflammatory drug (NSAID) belonging to the pyrrole acetic acid derivative class. The pharmaceutical material is commonly supplied as Tolmetin Sodium Dihydrate, with the CAS number 64490-92-2, molecular formula C₁₅H₁₄NNaO₃·2H₂O, and molecular weight 315.30 g/mol.
Tolmetin Sodium has analgesic, anti-inflammatory, and antipyretic activity and acts as a nonselective NSAID associated with inhibition of prostaglandin synthesis. It has been used in pharmaceutical products for the management of inflammatory and painful musculoskeletal conditions.
The current USP 2025 monograph identifies Tolmetin Sodium as 1H-Pyrrole-2-acetic acid, 1-methyl-5-(4-methylbenzoyl)-, sodium salt, dihydrate, with CAS 64490-92-2 and UNII 02N1TZF99F. The anhydrous sodium salt is separately identified as CAS 35711-34-3 with molecular weight 279.27 g/mol.
The USP definition requires Tolmetin Sodium to contain 98.0% to 102.0% of tolmetin sodium, calculated on the dried basis.
Tolmetin Sodium is a nonselective NSAID with analgesic, anti-inflammatory and antipyretic properties. The sodium salt is freely soluble in water, making it suitable for pharmaceutical formulations where the sodium salt form is required.
Tolmetin Sodium has historically been used in oral pharmaceutical dosage forms for conditions including rheumatoid arthritis and osteoarthritis.
Swapnroop supports pharmaceutical companies and qualified procurement organizations requiring Tolmetin Sodium API for formulation and manufacturing applications.
The API can be supplied according to applicable pharmaceutical specifications, including requirements aligned with USP where applicable. The current USP monograph specifies controls for identity, assay, organic impurities and loss on drying.
USP specifies that Tolmetin Sodium should be preserved in well-closed containers.
For bulk API supply, packaging should protect the material against contamination and excessive environmental exposure. Storage conditions should follow the applicable product specification and stability data.
Depending on the applicable supply arrangement, documentation may include:
Swapnroop Drugs & Pharmaceuticals provides Tolmetin Sodium API for qualified pharmaceutical, formulation and bulk procurement requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | 10.4–12.4% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | 10.4–12.4% |