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PHR1144

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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:
Molecular Weight:
318.13
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

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

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

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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.

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.

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Description
Pricing

Signal Word

Danger

Hazard Statements

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


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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)
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
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

Articles

A comparative UHPLC analysis of diclofenac sodium in gel using Chromolith® HighResolution RP-18 endcapped 100 x 2 mm I.D column and FPP 1.7 µm hybrid silica C18 100 x 2.1 mm I.D column with UV and MS detection.

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