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Y0001635

Diclofenac for system suitability

European Pharmacopoeia (EP) Reference Standard

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Synonym(s):
Diclofenac sodium salt, 2-[(2,6-Dichlorophenyl)amino]benzeneacetic acid sodium salt
Empirical Formula (Hill Notation):
C14H10Cl2NNaO2
CAS Number:
15307-79-6
Molecular Weight:
318.13
MDL number:
MFCD00082251
UNSPSC Code:
41116107
PubChem Substance ID:
329831520
NACRES:
NA.24

grade

pharmaceutical primary standard

API family

diclofenac

manufacturer/tradename

EDQM

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°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)

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General description

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 for system suitability EP Reference standard, intended for use in laboratory tests only as specifically prescribed in the European Pharmacopoeia.

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.

Packaging

The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Other Notes

Sales restrictions may apply.

related product

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N-(2,6-Dichlorophenyl)-2-indolinone, analytical standard

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PHR2443

Diclofenac Impurity E, Pharmaceutical Secondary Standard; Certified Reference Material

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Diclofenac Impurity F, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2447

Diclofenac Impurity D, Pharmaceutical Secondary Standard; Certified Reference Material

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Diclofenac Impurity C, Pharmaceutical Secondary Standard; Certified Reference Material

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Diclofenac Impurity B, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2442

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PHR2441

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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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George M Martin et al.
Journal of drugs in dermatology : JDD, 11(5), 600-608 (2012-04-25)
Diclofenac sodium 3% gel (Solaraze®) gained US approval for the treatment of actinic keratosis (AK) more than 10 years ago. Since the publication of the pivotal phase 3 studies, numerous clinical studies have assessed use of this therapy in a
R N Brogden et al.
Drugs, 20(1), 24-48 (1980-07-01)
Diclofenac sodium, a phenylacetic acid derivative, is a non-steroidal, anti-inflammatory, analgesic agent advocated for use in rheumatoid arthritis, degenerative joint disease, ankylosing spondylitis and allied conditions, and in the treatment of pain resulting from minor surgery, trauma and dysmenorrhoea. Published
D Aygün et al.
Histology and histopathology, 27(4), 417-436 (2012-03-01)
Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for the purpose of anti-inflammation, antipyretic, and analgesia. For this aim, they are used for the alleviation of pain, fever, and inflammation associated with rheumatoid arthritis, sports injuries, and temporary pain. However, treatment
P A Todd et al.
Drugs, 35(3), 244-285 (1988-03-01)
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) advocated for use in painful and inflammatory rheumatic and certain non-rheumatic conditions. It is available in a number of administration forms which can be given orally, rectally or intramuscularly. Conveniently, dosage adjustments are
Paul L McCormack et al.
Drugs, 68(1), 123-130 (2007-12-18)
*A new formulation of the nonselective NSAID diclofenac sodium suitable for intravenous bolus injection has been developed using hydroxypropyl beta-cyclodextrin as a solubility enhancer (HPbetaCD diclofenac). * HPbetaCD diclofenac intravenous bolus injection was shown to be bioequivalent to the existing
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