Diclofenac sodium salt

Pharmaceutical Secondary Standard; Certified Reference Material

2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid sodium salt
Empirical Formula (Hill Notation):
Número de CAS:
Peso molecular:
EC Number:
MDL number:
PubChem Substance ID:

Quality Level


certified reference material
pharmaceutical secondary standard




current certificate can be downloaded


HPLC: suitable
gas chromatography (GC): suitable

Featured Industry

Pharmaceutical (small molecule)



pharmacopeia traceability

traceable to BP 619
traceable to PhEur S0765000
traceable to USP 118880

SMILES string




InChI key


Gene Information

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General description

Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Diclofenac is a derivative of benzeneacetic acid. It is categorized under the class of non-steroidal anti-inflammatory drugs (NSAIDs). It shows inflammatory, analgesic and antipyretic activities.


These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Diclofenac sodium salt may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography and spectrophotometric techniques.

Biochem/physiol Actions

Standard NSAID and cyclooxygenase (COX) inhibitor. Major metabolites are 4´-hydroxydiclofenac and 5´-hydroxydiclofenac. Has been used as substrate selective for CYP2C9.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

Values of analytes vary lot to lot.
This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.


To see an example of a Certificate of Analysis for this material enter LRAC1513 in the slot below. This is an example certificate only and may not be the lot that you receive.




Acute Tox. 3 Oral - Aquatic Chronic 2 - Repr. 2 - STOT RE 1


6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

WGK Germany


Flash Point F

Not applicable

Flash Point C

Not applicable

Certificado de Análisis

Certificado de origen

Simultaneous determination of methylparaben, propylparaben, sodium diclofenac and its degradation product in a topical emulgel by reversed-phase liquid chromatography
Hajkova R, et al.
Analytica Chimica Acta, 467(1), 91-96 (2002)
Determination of diclofenac salts in pharmaceutical formulations
Bucci R, et al.
Fresenius Journal of Analytical Chemistry, 362(7-8), 577-582 (1998)
Alison E M Vickers et al.
International journal of molecular sciences, 19(12) (2018-12-24)
Human liver slice function was stressed by daily dosing of acetaminophen (APAP) or diclofenac (DCF) to investigate injury and repair. Initially, untreated human liver and kidney slices were evaluated with the global human U133A array to assess the extended culture...
High Performance Thin Layer Chromatographic Method for the Determination of Diclofenac Sodium in Pharmaceutical Formulations
Thongchai W, et al.
Chiang Mai Journal of Science, 33(1) (2006)
Shahinaze A Fouad et al.
International journal of pharmaceutics, 453(2), 569-578 (2013-06-26)
Microemulsion (ME) and poloxamer microemulsion-based gel (PMBG) were developed and optimized to enhance transport of diclofenac epolamine (DE) into the skin forming in-skin drug depot for sustained transdermal delivery of drug. D-optimal mixture experimental design was applied to optimize ME...
LC/MS/MS Analysis of Drugs in Plasma on Ascentis® Express C18 after Extraction using SPME LC Tips
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