PHR1144

Diclofenac sodium salt

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid sodium salt
• Empirical Formula (Hill Notation): C₁₄H₁₀Cl₂NNaO₂
• CAS Number: 15307-79-6
• Molecular Weight: 318.13
• EC Number: 239-346-4
• MDL number: MFCD00082251
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823164
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• agency: traceable to BP 619; traceable to Ph. Eur. S0765000; traceable to USP 118880
• API family: diclofenac
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: [Na+].[O-]C(=O)Cc1ccccc1Nc2c(Cl)cccc2Cl

Description

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.

Application

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.

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.

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

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.

Values of analytes vary lot to lot.

Footnote

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.

Recommended products

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Safety Information

• pictograms: GHS06,GHS08,GHS09
• signalword: Danger
• hcodes: H301,H361d,H372,H411
• pcodes: P202 - P260 - P264 - P273 - P280 - P301 + P310
• Hazard Classifications: Acute Tox. 3 Oral - Aquatic Chronic 2 - Repr. 2 - STOT RE 1
• Storage Class: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable