Description

Diclofenac Potassium is a potent non-steroidal anti-inflammatory drug (NSAID) belonging to the phenylacetic acid derivative class. Its primary value lies in its rapid onset of action and high efficacy in managing pain and inflammation, making it a critical active pharmaceutical ingredient (API) for various therapeutic formulations. This compound is essential for pharmaceutical manufacturers developing immediate-release oral solid dosage forms, such as tablets and capsules, targeting conditions like arthritis, migraines, and post-operative pain. Global supply chains rely on consistent, high-purity Diclofenac Potassium CAS NO 15307-81-0 to ensure the safety and effectiveness of final medicinal products.

Application

• Pharmaceutical API: Primary use as the active ingredient in immediate-release analgesic and anti-inflammatory tablets and capsules.
• Pain Management Formulations: Manufacture of medications for acute pain conditions, including dental pain, dysmenorrhea, and musculoskeletal injuries.
• Anti-arthritic Medications: Key component in drugs prescribed for osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
• Migraine Relief Products: Used in fast-acting formulations designed for the acute treatment of migraine attacks.
• Generic Drug Production: Sourcing for manufacturers producing bioequivalent versions of branded Diclofenac Potassium medications.
• Veterinary Pharmaceuticals: Application in anti-inflammatory and analgesic treatments for companion and livestock animals.
• Clinical Research: Serves as a reference standard or raw material in pharmacokinetic and pharmacodynamic studies.
• Compounding Pharmacy: Used by specialized pharmacies to prepare customized dosage forms for specific patient needs.

Basic Information

Product Name	Diclofenac Potassium
CAS No.	15307-81-0
Molecular Formula	C14H10Cl2KNO2
Molecular Weight	334.24 g/mol
Synonyms	2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid potassium salt; Potassium diclofenac; Diclofenac K; Cataflam (Brand Name); Voltaren-K; Arthrotec (combination product); Diclopot; (2,6-Dichlorophenyl)aminophenylacetic acid potassium salt
EINECS	239-346-4

Quality Control

Our Diclofenac Potassium is manufactured and tested under strict quality management systems to meet or exceed major pharmacopoeial standards, including USP, EP, and JP. Every batch undergoes comprehensive analytical testing for identity, potency, purity, and impurity profiles using validated methods such as HPLC, IR spectroscopy, and titration. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting compliance with agreed specifications for parameters like assay, related substances, residual solvents, heavy metals, and microbiological quality. We ensure traceability and supply chain integrity from raw materials to finished API.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature between 15°C and 25°C (59°F and 77°F). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a low-humidity environment to prevent degradation. Store away from incompatible materials.

Specification

Item	Specification
Appearance	White or almost white, hygroscopic, crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (Karl Fischer)	≤ 2.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.1% Total impurities: ≤ 0.5%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Total aerobic microbial count ≤ 10³ CFU/g Total combined yeasts/molds ≤ 10² CFU/g
Specified Microorganisms	Absence of E. coli, Salmonella, S. aureus, P. aeruginosa

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