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1188800

USP

Diclofenac sodium

United States Pharmacopeia (USP) Reference Standard

Synonym(s):

Diclofenac sodium salt, 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
MDL number:
MFCD00082251
UNSPSC Code:
41116107
PubChem Substance ID:
329749565
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

diclofenac

manufacturer/tradename

USP

application(s)

pharmaceutical (small molecule)

format

neat

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)

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General description

Diclofenac sodium is a sodium salt of diclofenac, a non-steroidal anti-inflammatory drug (NSAID). It prevents the synthesis of prostaglandin involved in pain, inflammation, and fever by inhibiting the cyclooxygenase enzyme activity.
This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia.For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Diclofenac sodium USP reference standard suitable for use in specified USP compendial quality tests and assays.

Also used to prepare acid stage standard, standard, standard stock, sensitivity, and system suitability solution for the assay, impurity analysis, identification, and performance test by using liquid chromatography coupled with UV detector according to the given below monographs of United States Pharmacopeia (USP): 
  • Diclofenac Sodium
  • Diclofenac Sodium Delayed-Release Tablets  
  • Diclofenac Sodium Extended-Release Tablets
  • Diclofenac Sodium Topical Solution
  • Diclofenac Sodium and Misoprostol Delayed-Release Tablets

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 products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind.  ​

Other Notes

Sales restrictions may apply.

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Diclofenac Impurity D, Pharmaceutical Secondary Standard; Certified Reference Material

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Signal Word

Danger

Hazard Statements

H301,H361d,H372,H411

Hazard Classifications

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

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

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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Diclofenac Sodium
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 42(4), 1347-1347 (2020)
Adaptation of a color reaction for spectrophotometric determination of diclofenac sodium and piroxicam in pure form and in pharmaceutical formulations
El-Didamony, AM and Amin, AS
Analytical Letters, 37(6), 1151-1162 (2004)
Diclofenac Sodium Extended-Release Tablets
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 40(6), 1350-1350 (2016)
Diclofenac Sodium Delayed-Release Tablets
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 40(6), 1348-1348 (2016)
Diclofenac Sodium and Misoprostol Delayed-Release Tablets
USP43-NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia, 43(5), 1353-1353 (2023)
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