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Merck

PHR1144

Diclofenac sodium salt

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid sodium salt

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About This Item

Empirical Formula (Hill Notation):
C14H10Cl2NNaO2
CAS Number:
15307-79-6
Molecular Weight:
318.13
NACRES:
NA.24
PubChem Substance ID:
329823164
UNSPSC Code:
41116107
EC Number:
239-346-4
MDL number:
MFCD00082251

Key Documents

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InChI key

KPHWPUGNDIVLNH-UHFFFAOYSA-M

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

SMILES string

[Na+].[O-]C(=O)Cc1ccccc1Nc2c(Cl)cccc2Cl

grade

certified reference material, pharmaceutical secondary standard

agency

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

Quality Level

300

Gene Information

human ... PTGS1(5742), PTGS2(5743)

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Related Categories

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 and EP (PhEur) primary standards, where they are available.

Other Notes

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.
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.
Values of analytes vary lot to lot.

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Danger

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

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

PHR1144-1G: + PHR1144-1G-PW:

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Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)
Determination of diclofenac salts in pharmaceutical formulations
Bucci R, et al.
Fresenius Journal of Analytical Chemistry, 362(7-8), 577-582 (1998)
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)
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
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
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Articles

UHPLC Analysis of Diclofenac in Gel

UHPLC analysis of diclofenac sodium using Chromolith® and FPP columns offers efficient detection with UV and MS.

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