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
• 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
• 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
• InChI: 1S/C14H11Cl2NO2.Na/c15-10-5-3-6-11(16)14(10)17-12-7-2-1-4-9(12)8-13(18)19;/h1-7,17H,8H2,(H,18,19);/q;+1/p-1
• InChI key: KPHWPUGNDIVLNH-UHFFFAOYSA-M
• Gene Information: human ... PTGS1(5742) , PTGS2(5743)

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.

Packaging

1 g

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.

Safety Information

• Pictograms: GHS06,GHS08,GHS09
• Signal Word: Danger
• Hazard Statements: H301 - H361d - H372 - H411
• Precautionary Statements: P201 - P273 - P301 + P310 + P330
• Hazard Classifications: Acute Tox. 3 Oral - Aquatic Chronic 2 - Repr. 2 - STOT RE 1
• Storage Class Code: 6.1C - Combustible, acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable