Description

Sodium Tolmetin Dihydrate is the sodium salt dihydrate form of Tolmetin, a non-steroidal anti-inflammatory drug (NSAID). This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and consistency of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers for the production of analgesic and anti-inflammatory medications targeting conditions such as osteoarthritis and rheumatoid arthritis.

Application

• Pharmaceutical API: Primary use as the active ingredient in solid oral dosage forms (e.g., tablets, capsules).
• Analgesic Formulations: Manufacture of medications for the relief of mild to moderate pain.
• Anti-inflammatory Drugs: Key component in drugs used to reduce inflammation and swelling.
• Antipyretic Medications: Used in formulations aimed at reducing fever.
• Rheumatology Treatments: Essential for producing drugs managing symptoms of rheumatoid arthritis and osteoarthritis.
• Clinical Research: Serves as a reference standard or raw material in pharmaceutical R&D and analytical laboratories.
• Generic Drug Manufacturing: Sourcing for the production of bioequivalent generic versions of branded Tolmetin sodium products.

Basic Information

Product Name	Sodium Tolmetin Dihydrate
CAS No.	64490-92-2
Molecular Formula	C15H14NNaO3 · 2H2O
Molecular Weight	315.29 g/mol (anhydrous basis)
Synonyms	Tolmetin Sodium Dihydrate; Sodium 1-Methyl-5-(4-methylbenzoyl)-1H-pyrrole-2-acetate Dihydrate; Tolmetin Sodium Salt Dihydrate; McN-2559; 1-Methyl-5-(p-toluoyl)pyrrole-2-acetic acid sodium salt dihydrate; Tolectin (Trade Name) Sodium Salt; Sodium Tolmetin
EINECS	Contact for details

Quality Control

Our Sodium Tolmetin Dihydrate is manufactured under strict quality systems suitable for pharmaceutical use. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency. A Certificate of Analysis (COA) documenting compliance with relevant pharmacopeial standards (such as USP/EP) is provided with every shipment to guarantee supply reliability and quality assurance for your production processes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	9.0% - 12.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.