Description

Diclofenac Sodium CAS NO 15307-79-6 is a potent non-steroidal anti-inflammatory drug (NSAID) widely recognized for its analgesic and antipyretic properties. It is a critical active pharmaceutical ingredient (API) essential for the formulation of effective pain management and anti-inflammatory medications. This compound is primarily required by pharmaceutical manufacturers and research institutions developing oral tablets, topical gels, and injectable solutions for treating conditions like arthritis, migraines, and post-operative pain.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription and over-the-counter (OTC) analgesic and anti-inflammatory medications.
• Oral Solid Dosage Forms: Formulation into tablets, capsules, and enteric-coated pills for systemic relief of pain and inflammation.
• Topical Formulations: Incorporation into gels, creams, and patches for localized pain relief with reduced systemic exposure.
• Injectable Solutions: Used in parenteral formulations for rapid post-operative or acute pain management.
• Veterinary Medicine: Application in veterinary pharmaceuticals for managing pain and inflammation in animals.
• Research & Development: Serves as a reference standard and key intermediate in pharmacological research and new drug development.

Basic Information

Product Name	Diclofenac Sodium
CAS No.	15307-79-6
Molecular Formula	C14H10Cl2NNaO2
Molecular Weight	318.13 g/mol
Synonyms	Diclofenac Sodium Salt; 2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid sodium salt; Voltaren; Aclonac; Aliviod; Arthrotec (in combination); Dyloject; Fenac; Flameril; GP 45840; NSC 339641; Sodium Diclofenac
EINECS	239-350-4

Quality Control

Our Diclofenac Sodium is manufactured under strict quality systems and can be supplied to meet various pharmacopoeial standards, including USP, EP, and BP. Every batch undergoes rigorous analytical testing to ensure identity, purity, and potency. A comprehensive Certificate of Analysis (COA) is provided, detailing results for assay, related substances, residual solvents, and microbiological quality, ensuring full traceability and compliance with cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to protect from moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White or almost white, hygroscopic, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on dried basis)
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.1%; Total impurities: ≤ 0.5%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbiological Enumeration	Meets EP/USP requirements for non-sterile APIs

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